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COVID-19 Updates

DateTitleCategories
12 April 2021FDA Advisory No.2021-0681 || Public Health Warning on Falsified COVID-19 Vaccine BNT162b2 Confirmed by the World Health Organization (WHO)COVID19-Related, Drugs Advisories2021-04-12 14:00:24
8 April 2021FDA has released a total of 410 COVID – 19 Test Kits (133 – PCR based, 115 – Rapid Antibody, 73 – Immunoassay and 89 – OthersCOVID19-Related, Device Announcements2021-04-08 16:02:08
31 March 2021FDA Advisory No. 2021-0664 || Public Health Warning on Fake COVID-19 VaccinesCOVID19-Related, Drugs Advisories2021-03-31 22:00:31
29 March 2021FDA Press Statement || Clarification on the purchase and use of Ivermectin 29 March 2021COVID19-Related, Press Statement2021-03-29 10:47:24
26 March 2021FDA has released a total of 408 COVID – 19 Test Kits (133 – PCR based, 115 – Rapid Antibody, 73 – Immunoassay and 87 – OthersCOVID19-Related, Device Announcements2021-03-26 13:23:50
23 March 2021FDA Memorandum No. 2021-009 || Minimum Performance Requirements for COVID-19 Test Kits Used for SARS-CoV-2 InfectionCOVID19-Related, FDA Memorandum2021-03-23 17:10:44
29 January 2021FDA has released a total of 366 COVID – 19 Test Kits (126 – PCR based, 105 – Rapid Antibody, 68 – Immunoassay and 67 – Others).COVID19-Related, Device Announcements2021-01-29 13:34:14
21 January 2021FDA has released a total of 358 COVID – 19 Test Kits (123 – PCR based, 106 – Rapid Antibody, 68 – Immunoassay and 61 – Others).COVID19-Related, Device Advisories2021-01-21 16:29:35
20 January 2021Press Statement || Donated COVID-19 Vaccines Require FDA AuthorizationCOVID19-Related, Press Statement2021-01-20 13:53:33
14 January 2021FDA Philippines Grants Emergency Use Authorization to Pfizer-BioNTech COVID-19 VaccineCOVID19-Related, Press Statement2021-01-14 12:17:40
8 January 2021Press Statement || Updates on Applications for Conduct of Clinical Trials and Emergency Use Authorization of COVID-19 VaccinesCOVID19-Related, Press Statement2021-01-08 17:21:04
7 January 2021FDA has released a total of 346 COVID – 19 Test Kits (121 – PCR based, 106 – Rapid Antibody, 68 – Immunoassay and 51 – Others).COVID19-Related, Device Announcements2021-01-07 15:23:36
28 December 2020Press Statement || Caution on Use of Unauthorized VaccinesCOVID19-Related, Press Statement2020-12-28 15:22:27
21 December 2020FDA has released a total of 335 COVID – 19 Test Kits (119 – PCR based, 104 – Rapid Antibody, 68 – Immunoassay and 44 – Others).COVID19-Related, Device Announcements2020-12-21 15:02:19
18 December 2020FDA Circular No. 2020-037 || Reissuance of the Guidelines on the Implementation of the Use of Electronic Means of Prescription for Drugs for the Benefit of Individuals Vulnerable to COVID-19COVID19-Related, FDA Circular2020-12-18 13:49:19
18 December 2020FDA Circular No. 2020-028-A || EXTENSION OF THE EFFECTIVITY OF FDA CIRCULAR NO. 2020-028 ENTITLED “REISSUANCE OF THE GUIDELINES FOR THE REGISTRATION OF DRUG PRODUCTS UNDER EMERGENCY USE (DEU) FOR THE CORONAVIRUS DISEASE 2019 (COVID-19)”COVID19-Related, FDA Circular2020-12-18 13:28:55
18 December 2020FDA Circular No. 2020-022-A || EXTENSION OF THE EFFECTIVITY OF FDA CIRCULAR NO. 2020-022 ENTITLED “REISSUANCE OF THE GUIDELINES ON THE IDENTIFICATION, NOTIFICATION, EVALUATION, REGULATORY ENFORCEMENT ACTION, AND REVIEW AND MONITORING OF DONATED HEALTH PRODUCTS SOLELY INTENDED TO ADDRESS COVID-19 PUBLIC HEALTH EMERGENCY”COVID19-Related, FDA Circular2020-12-18 11:19:42
14 December 2020FDA Circular No. 2020-036 || Guidelines on the Issuance of Emergency Use Authorization for Drugs and Vaccines for COVID-19COVID19-Related, FDA Circular2020-12-14 14:50:54
1 December 2020FDA has released a total of 282 COVID – 19 Test Kits (114 – PCR based, 101 – Rapid Antibody, 68 – Immunoassay and 35 – Others).COVID19-Related, Device Announcements2020-12-01 16:50:47
24 November 2020FDA Advisory No. 2020-1395-A || REITERATION OF FDA ADVISORY NO. 2020-1395 TO TAKE EXTREME CAUTION ON THE PURCHASE AND USE OF UNREGISTERED VACCINES FOR COVID-19COVID19-Related, Drugs Advisories2020-11-24 10:27:54
17 November 2020FDA has released a total of 306 COVID – 19 Test Kits (109 – PCR based, 99 – Rapid Antibody, 65 – Immunoassay and 33 – Others)COVID19-Related, Device Announcements2020-11-17 11:05:34
30 October 2020FDA has released a total of 303 COVID – 19 Test Kits (106 – PCR based, 99 – Rapid Antibody, 65 – Immunoassay and 33 – Others)COVID19-Related, Device Announcements2020-10-30 21:27:45
23 October 2020FDA Advisory No. 2020-1928 || Delisted Companies with Issued Special Certification for COVID-19 Rapid Antibody Test KitsCOVID19-Related, Device Advisories2020-10-23 15:01:31
20 October 2020FDA has released a total of 282 COVID – 19 Test Kits (99 – PCR based, 97 – Rapid Antibody, 59 – Immunoassay and 27 – Others)COVID19-Related, Device Announcements2020-10-20 12:55:25
14 October 2020FDA Circular No. 2020-0029 || Guidance on Applications for the Conduct of COVID-19 Clinical TrialsCOVID19-Related, FDA Circular2020-10-14 14:27:27
29 September 2020FDA has released a total of 260 COVID – 19 Test Kits (89 – PCR based, 93 – Rapid Antibody, 58 – Immunoassay and 20 – Others)COVID19-Related, Device Announcements2020-09-29 09:23:35
22 September 2020FDA Circular No. 2020-015-B || Further Amendment to FDA Circular No. 2020-015 entitled “Interim Measures to Ensure Access to Vitamin Drug Products during the Coronavirus Disease 2019 (COVID-19) Pandemic”COVID19-Related, FDA Circular2020-09-22 18:12:48
22 September 2020FDA Circular No.2020-007-B || Further Amendment to FDA Circular No. 2020-007 entitled “Guidelines on the Implementation of the Use of Electronic Means of Prescription for Drugs for the Benefit of Individuals Vulnerable to COVID-19”COVID19-Related, FDA Circular2020-09-22 18:00:44
22 September 2020FDA Circular No. 2020-028 || Reissuance of the Guidelines for the Registration of Drug Products under Emergency Use (DEU) for the Coronavirus Disease 2019 (COVID-19)COVID19-Related, FDA Circular2020-09-22 17:48:23
14 September 2020FDA has released a total of 249 COVID – 19 Test Kits (87 – PCR based, 90 – Rapid Antibody, 58 – Immunoassay and 14 – Others)COVID19-Related, Device Announcements2020-09-14 11:50:14
3 September 2020FDA Memorandum No. 2020-022 || Performance Testing of Antigen Based Test Kits with Issued Special CertificationCOVID19-Related, FDA Memorandum2020-09-03 10:53:29
1 September 2020FDA Circular No. 2020-015-A || Amendment to FDA Circular No. 2020-015 entitled “Interim Measures to Ensure Access to Vitamin Drug Products during the Coronavirus Disease 2019 (COVID-19) Pandemic”COVID19-Related, FDA Circular2020-09-01 13:37:21
31 August 2020FDA has released a total of 249 COVID – 19 Test Kits (87 – PCR based, 90 – Rapid Antibody, 58 – Immunoassay and 14 – Others)COVID19-Related, Device Announcements2020-08-31 13:58:02
26 August 2020FDA Circular No. 2020-012-B || Further Amendment to FDA Circular (FC) Nos. 2020-012 and 2020-012-A entitled “Guidelines for the Registration of Drug, Products under Emergency Use (DEU) for the Coronavirus Disease 2019 (COVID-19)”COVID19-Related, FDA Circular2020-08-26 14:15:26
26 August 2020FDA Circular No. 2020-007-A || Amendment to FDA Circular (FC) No. 2020-007 entitled “Guidelines in the Implementation of the Use of Electronic Means of Prescription for Drugs for the Benefit of Individuals Vulnerable to COVID-19”COVID19-Related, FDA Circular2020-08-26 13:59:53
25 August 2020FDA Advisory No. 2020-1546 || Regulation of Face ShieldCOVID19-Related, Device Advisories2020-08-25 14:04:01
25 August 2020FDA Circular No. 2020-027 || Conduct of Risk-Based Local Inspections in Light of the COVID-19 PandemicCOVID19-Related, FDA Circular2020-08-25 13:41:35
24 August 2020FDA Circular No. 2020-026 || Food and Drug Action Center (FDAC) New Normal Operational Guidelines of the Food and Drug Administration (FDA)COVID19-Related, FDA Circular2020-08-24 19:08:08
24 August 2020FDA Memorandum Circular No. 2020-001-B || Extension of the Effectivity of FDA Memorandum Circular No. 2020-001 entitled “Interim Guidelines for the Issuance of Provisional License to Operate (LTO) and Certificate of Product Notification (CPN) for Manufacturers of Rubbing Alcohol Products under the Center for Cosmetics Regulation and Research” issued on 19 March 2020 and Its Amendment, FDA Memorandum Circular No. 2020-001-A issued on 16 April 2020COVID19-Related, Memorandum Circular2020-08-24 14:32:24
20 August 2020FDA Circular No. 2020-024 || UPDATED GUIDELINES FOR APPLICATION OF AUTHORIZATIONS AT THE FOOD AND DRUG ADMINISTRATION IN LIGHT OF THE COMMUNITY QUARANTINE DECLARATIONSCOVID19-Related, FDA Circular2020-08-20 15:01:18
17 August 2020FDA has released a total of 235 COVID – 19 Test Kits (81 – PCR based, 86 – Rapid Antibody, 58 – Immunoassay and 10 – Others)COVID19-Related, Device Announcements2020-08-17 20:05:43
13 August 2020ONLINE SUBMISSION OF FOOD EXPORT CERTIFICATE AND FOOD COMMODITY CLEARANCECOVID19-Related, General Announcements2020-08-13 11:56:33
12 August 2020FDA Circular No. 2020-022 || REISSUANCE OF THE GUIDELINES ON THE IDENTIFICATION, NOTIFICATION, EVALUATION, REGULATORY ENFORCEMENT ACTION, AND REVIEW AND MONITORING OF DONATED HEALTH PRODUCTS SOLELY INTENDED TO ADDRESS COVID-19 PUBLIC HEALTH EMERGENCYCOVID19-Related, FDA Circular2020-08-12 17:50:57
3 August 2020RRD-CDRRHR ANNOUNCEMENT 03 August 2020COVID19-Related, Device Announcements2020-08-03 19:37:15
30 July 2020FDA has released a total of 214 COVID – 19 Test Kits (75 – PCR based, 79 – Rapid Antibody, 53 – Immunoassay and 7 – Others)COVID19-Related, Device Announcements2020-07-30 17:15:47
27 July 2020FDA Circular No. 2020-012-A || Amendment to FDA Circular No. 2020-012 entitled Guidelines for the Registration of Drug Products under Emergency Use (DEU) for the Coronavirus Disease 2019 (COVID-19)COVID19-Related, FDA Circular2020-07-27 16:41:48
24 July 2020FDA has released a total of 211 COVID – 19 Test Kits (72 – PCR based, 79 – Rapid Antibody, 55 – Immunoassay and 5 – Others)COVID19-Related, Device Announcements2020-07-24 17:08:06
24 July 2020FDA Advisory No. 2020-1395 || Caution On The Purchase And Use Of Unregistered Vaccines For COVID-19COVID19-Related, Drugs Advisories2020-07-24 16:58:02
23 July 2020FDA Advisory No. 2020-624-A || Payment through fund transferCOVID19-Related, General Advisories2020-07-23 10:25:05
22 July 2020FDA Circular No. 2020-011-A || RESCISSION OF FDA CIRCULAR NO. 2020-011 entitled “GUIDELINES OF ALCOHOL BASED SANITIZER FORMULATIONS IN LIGHT OF THE DECLARATION OF STATE OF CALAMITY DUE TO COVID-19”COVID19-Related, FDA Circular2020-07-22 09:51:08
20 July 2020FDA Advisory No. 2020-1374 || ADVISE ON THE USE OF FACE MASK WITH VALVECOVID19-Related, Device Advisories2020-07-20 17:30:42
20 July 2020FDA Circular No. 2020-006-B || FURTHER AMENDMENT TO THE FDA CIRCULAR NO. 2020-006 ENTITLED “GUIDANCE FOR APPLICATIONS AND TRANSACTIONS AT THE FOOD AND DRUG ADMINISTRATION IN LIGHT OF THE COMMUNITY QUARANTINE DECLARATION” ISSUED ON 17 MARCH 2020 AND ITS AMENDMENT ISSUED ON 2 APRIL 2020COVID19-Related, FDA Circular2020-07-20 14:57:11
17 July 2020FDA has released a total of 208 COVID – 19 Test Kits (72 – PCR based, 78 – Rapid Antibody, 53 – Immunoassay and 5 – Others)COVID19-Related, Device Announcements2020-07-17 16:42:31
10 July 2020FDA has released a total of 204 COVID – 19 Test Kits (71 – PCR based, 77 – Rapid Antibody, 51 – Immunoassay and 5 – Others)COVID19-Related, General Announcements2020-07-10 17:18:46
10 July 2020FDA Circular No. 2020-020 || Interim Guidelines Governing the Issuance of a Permit to Register to Drug Importers for Foreign Drug ManufacturersCOVID19-Related, FDA Circular2020-07-10 15:03:25
1 July 2020Updated List of Notified Hand Sanitizers and Rubbing Alcohol Products as of 01 July 2020Cosmetic Announcements, COVID19-Related2020-07-01 14:58:17
24 June 2020FDA has released a total of 178 COVID – 19 Test Kits (60 – PCR based, 69 – Rapid Antibody, 45 – Immunoassay and 4 – Others)COVID19-Related, Device Announcements2020-06-24 17:17:16
24 June 2020Updated List of Notified Hand Sanitizers and Rubbing Alcohol Products as of 24 June 2020Cosmetic Announcements, COVID19-Related2020-06-24 16:34:59
22 June 2020FDA Advisory No. 2020-1181 || List of FDA Notified Medical Face MasksCOVID19-Related, Device Advisories2020-06-22 16:04:03
19 June 2020FDA Advisory No. 2020-1131-A || Paalala sa Publiko Tungkol sa Paggamit ng DexamethasoneCOVID19-Related, Drugs Advisories2020-06-19 17:06:25
19 June 2020FDA Advisory No. 2020-1131 || Reminder on the Use of DexamethasoneCOVID19-Related, Drugs Advisories2020-06-19 14:14:13
18 June 2020FDA Advisory No. 2020-1080 || Public Health Warning Against the Purchase and Use of the Uncertified COVID-19 Test Kit “WIZ BIOTECH Diagnostic Kit (Colloidal Gold) for IgG/ImM Antibody to SARS-CoV-2”COVID19-Related, Device Advisories2020-06-18 13:58:05
17 June 2020Updated List of Notified Hand Sanitizers and Rubbing Alcohol Products as of 17 June 2020Cosmetic Announcements, COVID19-Related2020-06-17 13:45:37
16 June 2020FDA has released a total of 161 COVID – 19 Test Kits (59 – PCR based, 62 – Rapid Antibody, 36 – Immunoassay and 4 – Others)COVID19-Related, Device Announcements2020-06-16 10:02:09
15 June 2020FDA Advisory No. 2020-1055 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “INFRARED THERMOMETER”COVID19-Related, Device Advisories2020-06-15 14:44:23
15 June 2020FDA Advisory No. 2020-1054 || Public Health Warning Against the Purchase and Use of the Uncertified COVID-19 Test Kit “Testsealabs One Step Rapid Test- SARS-cov-2 IgG/IgM Test Cassette”COVID19-Related, Device Advisories2020-06-15 14:25:27
11 June 2020FDA has released a total of 155 COVID-19 Test Kits (56- PCR based, 60- Rapid Antibody, 36- Immunoassay and 3- Others)COVID19-Related, Device Announcements2020-06-11 21:28:43
11 June 2020FDA Advisory No. 2020-1057 || ON THE USE OF RADIATION DEVICES IN THE DIAGNOSIS OF COVID-19 INFECTIONSCOVID19-Related, Device Advisories2020-06-11 16:35:20
11 June 2020Updated List of Notified Hand Sanitizers and Rubbing Alcohol Products as of 10 June 2020Cosmetic Announcements, COVID19-Related2020-06-11 11:14:56
9 June 2020FDA Advisory No. 2020-1037 || Public Health Warning Against the Purchase and Use of Uncertfied COVID-19 Test Kit “DeepBlue Covid-19 (SARS-CoV-2) Antibody Test Kit”COVID19-Related, Device Advisories2020-06-09 16:00:30
5 June 2020FDA Advisory No. 2020-1038 || Risks Associated with the Use of FavipiravirCOVID19-Related, Drugs Advisories2020-06-05 18:15:02
3 June 2020Updated List of Notified Hand Sanitizers and Rubbing Alcohol Products as of 03 June 2020Cosmetic Announcements, COVID19-Related2020-06-03 15:27:50
3 June 2020FDA approved 11 additional kits (5 PCR, 6 SEROLOGIC) as of 02 June 2020. Total registered COVID-19 Test Kits for commercial use is now 132.COVID19-Related, Device Announcements2020-06-03 10:27:56
29 May 2020FDA Circular No. 2020-009-C || EXTENSION OF EFFECTIVITY OF FDA CIRCULAR 2020-009 ENTITLED “GUIDELINES ON THE IDENTIFICATION, NOTIFICATION, EVALUATION, REGULATORY ENFORCEMENT ACTION, AND REVIEW AND MONITORING OF DONATED HEALTH PRODUCTS SOLELY INTENDED TO ADDRESS COVID-19 PUBLIC HEALTH EMERGENCY”COVID19-Related, FDA Circular2020-05-29 17:57:11
28 May 2020COSMETIC LABELLING REQUIREMENTS FOR RUBBING ALCOHOL AND SANITIZERSCosmetic Announcements, COVID19-Related2020-05-28 11:32:53
28 May 2020Updated List of Notified Hand Sanitizers and Rubbing Alcohol Products as of 27 May 2020Cosmetic Announcements, COVID19-Related2020-05-28 11:26:17
27 May 2020FDA approved 17 additional kits (1 PCR, 16 SEROLOGIC) as of 27 May 2020. Total registered COVID-19 Test Kits for commercial use is now 121.COVID19-Related, Device Announcements2020-05-27 19:50:20
26 May 2020FDA Circular No. 2020-018 || Interim Guidelines of the Importation and Manufacture of Personal Protective Equipment (PPE), Ventilators and Respirators to be used in the COVID-19 PandemicCOVID19-Related, FDA Circular2020-05-26 16:36:30
22 May 2020FDA approved 11 additional kits (4 PCR, 7 SEROLOGIC) as of 22 May 2020. Total registered COVID-19 Test Kits for commercial use is now 104.COVID19-Related, Device Announcements2020-05-22 17:26:43
20 May 2020Updated List of Notified Hand Sanitizers and Rubbing Alcohol Products as of 20 May 2020Cosmetic Announcements, COVID19-Related2020-05-20 15:13:59
20 May 2020FDA Advisory No. 2020-852 || Public Health Warning Against the Purchase and Use of Disinfectants/Biocides Products with Misleading Health Claims that Decrease the Risk for Coronavirus Disease (COVID-19) InfectionCosmetic Advisories, COVID19-Related2020-05-20 11:34:37
19 May 2020FDA approved 7 additional kits (2 PCR, 5 SEROLOGIC) as of 19 May 2020. Total registered COVID-19 Test Kits for commercial use is now 93.COVID19-Related, Device Announcements2020-05-19 17:31:57
18 May 2020FDA Circular No. 2020-017 || Prohibition on the Selling of Essential Emergency Medicines and Medical Devices Beyond the Price Ceiling/Range set by the Department Memorandum No. 2020-0058COVID19-Related, FDA Circular2020-05-18 14:44:49
15 May 2020FDA approved 4 additional SEROLOGIC test kits as of 15 May 2020. Total registered COVID-19 Test Kits for commercial use is now 86.COVID19-Related, Device Announcements2020-05-15 19:11:53
14 May 2020FDA approved 2 additional SEROLOGIC test kits as of 14 May 2020. Total registered COVID-19 Test Kits for commercial use is now 82.COVID19-Related, Device Announcements2020-05-14 15:58:09
14 May 2020Development of Drugs and VaccinesCOVID19-Related, Drugs Announcements2020-05-14 14:38:16
14 May 2020Clinical Trial Application ProcessCOVID19-Related, Drugs Announcements2020-05-14 14:37:33
14 May 2020FDA Advisory No. 2020-810 || Reminder on the Risk of QT Prolongation on the Use of Chloroquine or HydroxychloroquineCOVID19-Related, Drugs Advisories2020-05-14 09:40:31
13 May 2020Updated List of Notified Hand Sanitizers and Rubbing Alcohol Products as of 13 May 2020Cosmetic Announcements, COVID19-Related2020-05-13 12:11:20
11 May 2020FDA approved 3 additional kits (1 PCR, 2 SEROLOGIC) as of 11 May 2020. Total registered COVID-19 Test Kits for commercial use is now 80.COVID19-Related, Device Announcements2020-05-11 19:43:41
11 May 2020FDA Circular No. 2020-016 || Prohibition of Online Selling of FDA Certified COVID- 19 Antibody Test kitsCOVID19-Related, FDA Circular2020-05-11 11:41:49
8 May 2020FDA approved 2 additional RAPID test kits today 08 May 2020. Total registered COVID-19 Test Kits for commercial use is now 77.COVID19-Related, Device Announcements2020-05-08 20:09:39
8 May 2020FDA Advisory No. 2020-782 || Public Health Warning Against the Unapproved and Misleading Health Claims of Medical Devices that Decrease the Risk for Coronavirus Disease (COVID-19) InfectionCOVID19-Related, Device Advisories2020-05-08 16:00:19
6 May 2020Updated List of Notified Hand Sanitizers and Rubbing Alcohol Products as of 06 May 2020Cosmetic Advisories, COVID19-Related2020-05-06 17:38:20
5 May 2020FDA approved 5 additional kits (1 PCR, 4 RAPID) as of 05 May 2020. Total registered COVID-19 Test Kits for commercial use is now 75.COVID19-Related, Device Announcements2020-05-05 16:40:48
4 May 2020FDA approved 11 additional kits (3 PCR, 8 RAPID) as of 04 May 2020. Total registered COVID-19 Test Kits for commercial use is now 70.COVID19-Related, Device Announcements2020-05-04 17:29:43
29 April 2020Updated List of Notified Hand Sanitizers and Rubbing Alcohol Products as of 29 April 2020Cosmetic Announcements, COVID19-Related2020-04-29 21:27:06
29 April 2020FDA approved 2 additional kits (1 PCR, 1 RAPID) as of 29 April 2020. Total registered COVID-19 Test Kits for commercial use is now 59.COVID19-Related, Device Announcements2020-04-29 16:33:37
29 April 2020FDA Circular No. 2020-009-B || AMENDMENT TO INCLUDE RESPIRATORY THERAPY DEVICES IN THE LIST OF MEDICAL DEVICES COVERED BY FDA CIRCULAR NO. 2020-009, AS AMENDED BY FDA CIRCULAR NO. 2020-009-ACOVID19-Related, FDA Circular2020-04-29 12:21:30
29 April 2020FDA Advisory No. 2020-761 || FDA CLEARANCE OF RESPIRATORY THERAPY DEVICES PRIOR CUSTOMS RELEASECOVID19-Related, Device Advisories2020-04-29 11:03:05
24 April 2020FDA approved 3 additional kits (1 PCR, 2 RAPID) as of 24 April 2020. Total registered COVID-19 Test Kits for commercial use is now 57.COVID19-Related, Device Announcements2020-04-24 16:23:04
24 April 2020FDA Advisory No. 2020-750 || Releasing of FDA Authorizations and Payment thru Fund TransferCOVID19-Related, General Advisories2020-04-24 12:43:38
23 April 2020FDA Advisory No. 2020-744 || ADVISORY FOR THE ISSUANCE OF SPECIAL PERMIT FOR MEDICAL RADIATION FACILITIES USING LOANED MOBILE X-RAY DEVICES DURING THE COVID-19 PANDEMICCOVID19-Related, Device Advisories2020-04-23 15:52:17
23 April 2020FDA approved 10 additional kits (4 PCR, 6 RAPID) as of 22 April 2020. Total registered COVID-19 Test Kits for commercial use is now 54.COVID19-Related, Device Announcements2020-04-23 08:56:28
22 April 2020Updated List of Notified Hand Sanitizers and Rubbing Alcohol Products as of 22 April 2020Cosmetic Announcements, COVID19-Related2020-04-22 15:58:24
21 April 2020FDA approved 1 additional PCR Test Kit as of 20 April 2020. Total registered COVID-19 Test Kits for commercial use is now 44.COVID19-Related, Device Announcements2020-04-21 16:52:43
21 April 2020FDA Circular No. 2020-015 || Interim Measures to Ensure Access to Vitamin Drug Products during the Coronavirus Disease 2019 (COVID-19) PandemicCOVID19-Related, FDA Circular2020-04-21 16:10:50
21 April 2020RITM TO EVALUATE FDA APPROVED COVID-19 RAPID ANTIBODY TEST KITSCOVID19-Related, Press Statement2020-04-21 13:34:34
20 April 2020FDA Memorandum No. 2020-011 || Performance Testing of Antibody Test kits with Issued Special CertificationCOVID19-Related, FDA Memorandum2020-04-20 16:40:18
18 April 2020FDA Advisory No. 2020-671 || Varying Specifications and Use of COVID-19 Rapid Antibody Test KitsCOVID19-Related, Device Advisories2020-04-18 15:24:21
17 April 2020FDA Advisory No. 2020-549 || Reminders to the General Public on the Proper Selection and Use of Household Cleaners and Disinfectant ProductsCosmetic Advisories, COVID19-Related2020-04-17 14:13:38
16 April 2020FDA approved 5 additional kits today (3 PCR, 2 RAPID), 16 April 2020. Total registered COVID-19 Test Kits for commercial use is now 43.COVID19-Related, Device Announcements2020-04-16 17:00:22
16 April 2020FDA Memorandum Circular No. 2020-001-A || Amendment to FDA Memorandum Circular No. 2020-001 entitled Interim Guidelines for the Issuance of Provisional License to Operate (LTO) and Certificate of Product Notification (CPN) for Manufacturers of Rubbing Alcohol Products under the Center for Cosmetics Regulation and ResearchCOVID19-Related, Memorandum Circular2020-04-16 16:36:14
16 April 2020FDA Advisory No. 2020-624 || Additional Payment ChannelCOVID19-Related, General Advisories2020-04-16 14:06:35
15 April 2020Updated List of Notified Hand Sanitizers and Rubbing Alcohol Products as of 15 April 2020Cosmetic Announcements, COVID19-Related2020-04-15 18:13:41
14 April 2020FDA approved 1 additional RAPID kit today 14 April 2020. Total registered COVID-19 Test Kits for commercial use is now 38COVID19-Related, Device Announcements2020-04-14 16:34:09
13 April 2020FDA approved 4 additional kits today (1 PCR, 3 RAPID), 13 April 2020. Total registered COVID-19 Test Kits for commercial use is now 37.COVID19-Related, Device Announcements2020-04-13 16:33:32
8 April 2020Updated List of Notified Hand Sanitizers and Rubbing Alcohol Products as of 07 April 2020Cosmetic Announcements, COVID19-Related2020-04-08 21:19:14
8 April 2020FDA WARNS THE PUBLIC ON DRUGS AND VACCINES WITH UNPROVEN CLAIMS FOR COVID-19 TREATMENTCOVID19-Related, Press Statement2020-04-08 17:33:08
8 April 2020FDA approved 1 additional PCR Test Kit today, 08 April 2020. Total registered COVID-19 Test Kits for commercial use is now 33.COVID19-Related, Device Announcements2020-04-08 16:22:51
8 April 2020FDA Circular No. 2020-014 || Interim Guidelines on the Manufacture of Personal Protective Equipment (PPE), Ventilators, and Respirators in Light of COVID-19 SituationCOVID19-Related, FDA Circular2020-04-08 13:29:29
7 April 2020FDA approved 1 additional PCR Test Kit today, 07 April 2020. Total registered COVID-19 Test Kits for commercial use is now 32.COVID19-Related, Device Announcements2020-04-07 16:30:24
7 April 2020FDA approved 1 additional Rapid Antibody Test Kit as of 06 April 2020. Total registered COVID-19 Test Kits for commercial use is now 31.COVID19-Related, Device Announcements2020-04-07 09:26:50
6 April 2020FDA Advisory No. 2020-547 || Updated Procedure for FDA Clearance of Personal Protective Equipment (PPE) Prior to Customs ReleaseCOVID19-Related, Device Advisories2020-04-06 16:39:08
3 April 2020FDA approved 2 additional kits today (1 PCR, 1 RAPID), 03 April 2020. Total registered COVID-19 Test Kits for commercial use is now 30.COVID19-Related, Device Announcements2020-04-03 19:37:36
3 April 2020FDA Advisory No. 2020-513 || FDA Approves the First Locally Manufactured Test Kit for COVID-19 for Commercial UseCOVID19-Related, Device Advisories2020-04-03 19:19:46
3 April 2020Joint Memorandum Circular No. 01 Series Of 2020 || CREATION OF BAYANIHAN ONE STOP SHOP FOR SECURING LICENSE TO OPERATE (LTO) TO IMPORT COVID-19 CRITICAL COMMODITIES FOR COMMERCIAL DISTRIBUTIONCOVID19-Related, Memorandum Circular2020-04-03 16:17:46
2 April 2020FDA Circular No. 2020-013 || Guidelines for Monitoring Drug Products Used for the Treatment of COVID-19COVID19-Related, FDA Circular2020-04-02 16:27:36
2 April 2020FDA Circular No. 2020-012 || Guidelines for the Registration of Drug Products under Emergency Use (DEU) for the Coronavirus Disease 2019 (COVID-19)COVID19-Related, FDA Circular2020-04-02 16:13:59
2 April 2020FDA Circular No. 2020-006-A || AMENDMENT TO FDA CIRCULAR NO. 2020-006 ENTITLED “GUIDANCE FOR APPLICATIONS AND TRANSACTIONS AT THE FOOD AND DRUG ADMINISTRATION IN LIGHT OF THE COMMUNITY QUARANTINE DECLARATION” ISSUED ON 17 MARCH 2020COVID19-Related, FDA Circular2020-04-02 14:36:00
1 April 2020FDA Advisory No. 2020-498 || PURCHASE AND ADMINISTRATION OF FDA APPROVED COVID-19 RAPID ANTIBODY TEST KITSCOVID19-Related, Drugs Advisories2020-04-01 18:24:59
1 April 2020FDA Advisory No. 2020-497 || DISTRIBUTION OF FDA APPROVED COVID-19 RAPID ANTIBODY TEST KITSCOVID19-Related, Device Advisories2020-04-01 18:02:40
1 April 2020FDA Advisory No. 2020-496 || Public Health Warning Against Do-It-Yourself Hand Sanitizers/DisinfectantsCosmetic Advisories, COVID19-Related2020-04-01 17:33:37
1 April 2020FDA approved 2 additional Rapid Antibody Test Kits today, 01 April 2020. Total registered COVID-19 Test Kits for commercial use is now 28.COVID19-Related, Device Announcements2020-04-01 16:09:51
31 March 2020FDA approved 3 additional kits today (2 PCR, 1 RAPID), 31 March 2020. Total registered COVID-19 Test Kits for commercial use is now 26.COVID19-Related, Device Announcements2020-03-31 17:58:50
30 March 2020Rapid Diagnostic Test FAQsCOVID19-Related, Device Announcements2020-03-30 13:38:46
30 March 2020FDA APPROVES RAPID ANTIBODY TEST KITS FOR COVID-19COVID19-Related, Press Statement2020-03-30 12:48:50
30 March 2020FDA Advisory No. 2020-483 || FDA APPROVES RAPID ANTIBODY TEST KITS FOR COVID-19COVID19-Related, Device Advisories2020-03-30 12:43:29
30 March 2020FDA Advisory No. 2020-452 || Baseless Claims of “Prodex-B” as Anti-Viral Treatment for COVID-19COVID19-Related, Drugs Advisories2020-03-30 10:11:37
27 March 2020FDA Circular No. 2020-009-A || AMENDMENT TO INCLUDE VENTILATORS,RESPIRATORS AND THEIR RESPECTIVE ACCESSORIES TO THE LIST OF MEDICAL DEVICES COVERED BY FDA CIRCULAR NO. 2020-009COVID19-Related, FDA Circular2020-03-27 16:38:25
27 March 2020FDA approved 3 additional kits today, 27 March 2020. Total registered COVID-19 Test Kits for commercial use is now 18.COVID19-Related, Device Announcements2020-03-27 16:20:24
27 March 2020FDA Advisory No. 2020-451-A || FDA EMAIL HOTLINE PARA SA MGA SUMBONG SA PRODUKTO NA MAY KINALAMAN SA COVID-19COVID19-Related, General Advisories2020-03-27 15:38:43
27 March 2020FDA Advisory No. 2020-451 || FDA EMAIL HOTLINE FOR COVID-19 RELATED REPORTS ON CONSUMER PRODUCTSCOVID19-Related, General Advisories2020-03-27 15:28:55
27 March 2020FDA Advisory No. 2020-450 || Pharmacies to Dispense Hydroxychloroquine to Patients with Prescriptions for the Drug UseCOVID19-Related, Drugs Advisories2020-03-27 14:06:05
27 March 2020FDA Advisory No. 2020-449 || FDA Clearance of Ventilators, Respirators and Accessories Prior Customs ReleaseCosmetic Advisories, COVID19-Related2020-03-27 08:32:32
26 March 2020FDA approved 3 additional kits today, 26 March 2020. Total registered COVID-19 Test Kits for commercial use is now 15.COVID19-Related, Device Announcements2020-03-26 15:05:55
26 March 2020UNREGISTERED COVID-19 TEST KITSCOVID19-Related, Press Statement2020-03-26 11:23:20
25 March 2020FDA approved 2 additional kits today, 25 March 2020. Total registered COVID-19 Test Kits for commercial use is now 12.COVID19-Related, Device Announcements2020-03-25 18:59:02
25 March 2020FDA Circular No. 2020-005-A || Amendment to FDA Circular No, 2020-005 re: Prohibition on the Online Selling of Essential Emergency Medical Supplies Beyond the Price Ceiling/Range set by Department Memorandum No. 2020-0058 and Department Memorandum No. 2020-0058-ACOVID19-Related, FDA Circular2020-03-25 12:24:57
24 March 2020FDA approved 1 additional kit today, 24 March 2020. Total registered COVID-19 Test Kits for commercial use is now 10.COVID19-Related, Device Announcements2020-03-24 18:40:19
24 March 2020Dapat bang uminom ng gamot tulad ng Hydroxychloroquine o Chloroquine para maiwasan ang COVID-19?COVID19-Related, Drugs Announcements2020-03-24 11:02:04
24 March 2020Should I take medicine like Hydroxychloroquine or Chloroquine to prevent COVID-19?COVID19-Related, Drugs Announcements2020-03-24 11:00:29
23 March 2020FDA approved 1 additional kit today, 23 March 2020. Total registered COVID-19 Test Kits for commercial use is now 9.COVID19-Related, Device Announcements2020-03-23 18:36:13
22 March 2020FDA Advisory No. 2020-447 || WALA PANG APRUBADONG POINT-OF-CARE O INSTANT COVID 19 TEST KITSCOVID19-Related, Device Advisories2020-03-22 12:37:54
21 March 2020FDA Advisory No. 2020-434 || Public Health Advisory on the Purchase and Use of the Infared Thermometer for Medical Use Offered for Sale OnlineCOVID19-Related, Device Advisories2020-03-21 14:55:43
20 March 2020FDA released 4 kits today, 20 March 2020. Total registered COVID-19 Test Kits for commercial use is now 8COVID19-Related, Device Announcements2020-03-20 17:12:52
20 March 2020The FDA released two (2) more Approved COVID-19 Test Kits for Commercial Use today 20 March 2020.COVID19-Related, Device Announcements2020-03-20 16:08:36
20 March 2020FDA Advisory No. 2020-422 || UPDATED LIST OF NOTIFIED HAND SANITIZERS AND REGISTERED TOPICAL ANTISEPTICS AND ANTIBACTERIALSCosmetic Advisories, COVID19-Related2020-03-20 14:15:35
20 March 2020FDA Advisory No. 2020-420 || Procedure for FDA Clearance of Personal Protective Equipment (PPE) Prior Customs ReleaseCOVID19-Related, Device Advisories2020-03-20 10:04:27
19 March 2020FDA Memorandum Circular No. 2020-001 || Interim Guidelines for the Issuance of Provisional License to Operate (LTO) and Certificate of Product Notification (CPN) for Manufacturers of Rubbing Alcohol Products Under the Center for Cosmetics Regulation and ResearchCOVID19-Related, Memorandum Circular2020-03-19 17:30:02
19 March 2020LIST OF FDA APPROVED COVID-19 TEST KITS FOR COMMERCIAL USECOVID19-Related, Press Statement2020-03-19 15:35:17
19 March 2020FDA Circular No. 2020-009 || GUIDELINES ON THE IDENTIFICATION, NOTIFICATION, EVALUATION, REGULATORY ENFORCEMENT ACTION, AND REVIEW AND MONITORING OF DONATED HEALTH PRODUCTS SOLELY INTENDED TO ADDRESS COVID-19 PUBLIC HEALTH EMERGENCYCOVID19-Related, FDA Circular2020-03-19 15:15:56
19 March 2020FDA Advisory No. 2020-409 || List of Approved COVID-19 Test Kits for Commercial UseCOVID19-Related, Device Advisories2020-03-19 14:42:18
18 March 2020FDA Advisory No. 2020-350 || List of Notified Hand SanitizersCosmetic Advisories, COVID19-Related2020-03-18 15:45:56
18 March 2020PAGLABAS NG FDA NG “GUIDELINES IN THE IMPLEMENTATION OF THE USE OF ELECTRONIC MEANS OF PRESCRIPTION FOR DRUGS FOR THE BENEFIT OF INDIVIDUALS VULNERABLE TO COVID-19”COVID19-Related, Press Statement2020-03-18 13:11:07
17 March 2020FDAC temporary location starting 17 March 2020COVID19-Related, General Announcements2020-03-17 21:29:22
17 March 2020FDA Circular No. 2020-007 || GUIDELINES IN THE IMPLEMENTATION OF THE USE OF ELECTRONIC MEANS OF PRESCRIPTION FOR DRUGS FOR THE BENEFIT OF INDIVIDUALS VULNERABLE TO COVID-19COVID19-Related, FDA Circular2020-03-17 17:38:18
17 March 2020FDA Circular No. 2020-006 || GUIDANCE FOR APPLICATIONS AND TRANSACTIONS AT THE FOOD AND DRUG ADMINISTRATION IN LIGHT OF THE COMMUNITY QUARANTINE DECLARATIONCOVID19-Related, FDA Circular2020-03-17 16:14:16
15 March 2020FDA CLARIFIES AVAILABILTY OF COVID-19 TEST KITS IN THE COUNTRYCOVID19-Related, General Announcements2020-03-15 14:29:37
13 March 2020SUBMISSION HOURS OF THE FOOD AND DRUG ADMINISTRATION (FDA) AUTHORIZATIONS IN THE e-PORTAL SYSTEMCOVID19-Related, General Announcements2020-03-13 17:40:45
12 March 2020FDA Memorandum No. 2020-006 || Issuance of Special Certification for Imported Test Kits of COVID-19COVID19-Related, FDA Memorandum2020-03-12 16:25:25
12 March 2020FDA Circular No. 2020-005 || Prohibition on the Online Selling of Essential Emergency Medical Supplies Beyond the Price Ceiling/Range set by Department Memorandum No. 2020-0058 and Department Memorandum No. 2020-0058-ACOVID19-Related, FDA Circular2020-03-12 16:02:49
12 March 2020FDA Circular No. 2020-004 || Prohibition of Selling of COVID-19 Testing Kit without Authorization from FDACOVID19-Related, FDA Circular2020-03-12 15:47:02

COVID-19 FDA FAQs

FREQUENTLY ASKED QUESTIONS

COVID19 – Medical Device

This is an FDA authorization issued to companies that wish to distribute COVID-19 Test Kits (PCR and Serologic) commercially.

FDA Memorandum No. 2020-006: Issuance of Special Certification for Imported Test Kits of COVID 19 issued on March 12, 2020 states the following requirements:

  1. Letter of Intent
  2. Valid License to Operate as Medical Device Distributor/Importer/Exporter
  3. Fee of Php500.00 plus LRF (Php10.00)
  4. Product registration issued by the regulatory agency or their accredited third party from the countries with established regulation such as but not limited to US Food and Drug Administration, Therapeutic Goods Authority, European Union, Health Science Authority, Pharmaceutical and Medical Device Authority, Ministry of Food and Drug Safety (Korea) and Health Canada: or WHO prequalification or EUL

FDA Circular No. 2020-006 entitled “Guidance for Applications and Transactions at the Food and Drug Administration in light of the Community Quarantine Declaration” together with its amendment issuance FDA Circular No. 2020-006-A state the procedure on how to apply for the said certificate.

For companies who intend to manufacture COVID19 Test Kits, a Medical Device License to Operate (LTO) as Manufacturer must be secured first. FDA Administrative Order 2016-0003 entitled Guidelines on the Unified Licensing Requirements and Procedure of the Food and Drug Administration (FDA) provides the guidelines and processes for application.  The site master plan that need to be prepared by the company in preparation for the inspection can be downloaded at the FDA website under CDRRHR Downloadables.

After the issuance of the LTO, the Special Certification for COVID19 Test Kit must be secured (FDA Memorandum No. 2020-006: Issuance of Special Certification for Imported Test Kits of COVID 19).  The manufacturing company of COVID19 Test Kits must submit the product to validation testing conducted by the Research Institute for Tropical Medicine (RITM).

The following documents are equivalent to a certificate of product registration but are not limited to:

  • Certificate of Emergency Use approval from Korea Centers for Disease Control and Prevention or Ministry of Food and Drug Safety from Korea
  • Provisional Authorization from Health Sciences Authority (HSA) of Singapore
  • Nucleic Acid Reagent Test Kits for the Novel Corona (2019-nCoV) approved by the National Medical Products Administration (NMPA) of China
  • Emergency Use approval from US Food and Drug Administration
  • Therapeutic Good Administration (TGA) Letter of Inclusion from Australia
  • CE approval issued or duly recognized by the national regulatory agency or certification issued by a Notified Body for European Countries

Yes, however, a performance validation conducted by the Research Institute for Tropical Medicine (RITM) must be complied within a specified period as part of the FDA’s post-marketing surveillance of health products. You may check the FDA Memorandum No. 2020-011(Performance Testing of Antibody Test kits with Issued Special Certification)

  • For test kits issued with Special Certification you may check on this link

https://drive.google.com/drive/folders/1Dk8KjbCzk8g92HydWDRvg8K-ATp7gBez?fbclid=IwAR2v60QZvEV-cV18ft2ZLtvighX6oxCtn3_pWv41fUY2fxjdRo3joNxpXV0

  • Take note however that the approval is company specific. Each company should have a special certification prior to the importation of the product.  To request for the list of the importer/distributors, send an email to [email protected] and [email protected] and indicate the reason for the request.

The FDA has issued FDA Circular No. 2020-016 prohibiting the online selling of COVID19 test Kits to protect the public against the use and purchase of uncertified COVID19 test kits. This is to ensure the safety, efficacy and quality of In Vitro Diagnostic medical devices in the country. Further, this is not a Do-It-Yourself testing, it must be done by a licensed physician or a trained health professional. Please refer to these FDA Issuances: FDA Advisory No. 2020-497 (Distribution of FDA approved COVID-19 Rapid Antibody Test Kits), FDA Advisory No. 2020-498 (Purchase and Administration of FDA approved COVID-19 rapid antibody test kits) and FDA Circular No. 2020-004 (Prohibition of Selling of COVID-19 Testing Kit without Authorization from FDA).

Rapid test kits detect the presence of antibodies in an individual’s blood serum. It is important to consider the timing of the infection and the condition of the patient during the time of specimen collection. The selection of the type of kit to be used is also dependent on the indication, the information the doctor wants to obtain, and the specification of the kit.  Interpretation must be done with caution and clinical correlation. You may read the full advisory: FDA Advisory No. 2020-671 (Varying Specifications and Use of COVID-19 Rapid Antibody Test Kits). Additionally, you may click this link:

https://www.fda.gov.ph/rapid-diagnostic-test-faqs/

The FDA has already approved a number of COVID-19 test kits for local marketing. Thus, all companies who would require mass testing for their employees can purchase the COVID-19 test kits from these importers. A list of the local importers of the COVID-19 test kits with issued Special Certification is available upon request.

Administration of the test must be performed by a doctor or a trained health professional as indicated in FDA Advisory No. 2020-497 and FDA Advisory No. 2020-498.

The Special Certification for COVID-19 PCR Test Kit has no validity and will remain valid during this emergency situation, unless revoked.  However, for the Special Certification for COVID-19 Rapid Test Kit, a performance validation conducted by the Research Institute for Tropical Medicine (RITM) must be submitted within a specified period as indicated in the FDA Memorandum No. 2020-011.

A License to Operate as a Distributor/ Importer must be obtained by the company prior to importation. After securing the required LTO, importers are advised to apply for a Certificate of Product Notification (CPN) prior to commercial sale and distribution (FDA Circular 2020-018: Interim Guidelines of the Importation and Manufacture of Personal Protective Equipment (PPE), Ventilators and Respirators to  be used in the COVID-19 Pandemic). Face masks that are for commercial use may be imported and released from the Bureau of Customs (BOC) by presenting a copy of the importer’s valid License to Operate (LTO).

Cloth face masks are not under the jurisdiction of the FDA, thus, no authorization/certification will be issued by this Agency as of the time being.  However, if the cloth facemasks will be used in medical institutions/facilities then the products are be now considered as medical devices and should comply with the FDA regulation for facemasks.

For importers of Personal Protective Equipment (PPE) and specific medical devices essential for the management of COVID-19 for commercial distribution, the Anti-Red Tape Authority (ARTA) and the Food and Drug Administration (FDA) signed a Joint Memorandum for the Creation of Bayanihan One Stop Shop (BOSS) for securing a License to Operate to import COVID-19 critical commodities for commercial distribution (Joint Memorandum Circular No. 01 Series of 2020).

Take note however that for the importation of COVID-19 Test Kits, the regular LTO should be secured. Application for this is guided by FDA Circular No. 2016-004 for the procedure on the use of the new application form for LTO thru FDA electronic portal, and Administrative Order No. 2016-0003 for the guidelines on the Unified Licensing Requirements and Procedures.

All establishments that intend to manufacture PPEs/ventilators/respirators are required to secure an LTO as Medical Device Manufacturer. Please see Administrative Order No. 2016-0003 for the guidelines on securing a License to Operate.

Please be guided by  FDA Circular No. 2020-018 regarding the application for the product notification/registration.

Clinical Thermometer is a class B medical device and included in the list of registrable products based on FDA Circular 2020-001.  Thermometers are therefore required to be registered.. Administrative Order No 2018-002 and  FDA Circular No. 2020-001 indicates the requirements for CMDR.

The application for CMDR must be submitted through [email protected] Only paid applications will be processed.  This is few of the COVID related products that are allowed to apply for initial application.

  1. COVID-19 Test Kit Donations – certification for donated COVID-19 test kits shall be coursed through solely by the Bureau of International Health Cooperation (BIHC) of the Department of Health (DOH).
  2. PPEs – for foreign donations of PPEs, clearance from FDA shall not be needed.