All comments can be sent at [email protected]. Deadline of submission of comments shall be by 04 March 2022.
I. RATIONALE
On 25 February 2014, FDA Memorandum Circular No. 2014-005 entitled “Updated List of Medical Devices required to be registered prior to sale, distribution and use” was issued to provide the initial list of medical devices including IVDs that are required for registration with the Food and Drug Administration (FDA).
With the occurrence of the pandemic due to COVID-19, FDA Memorandum (FM) No. 2020-006 entitled “Issuance of Special Certification for Imported Test Kits of COVID-19” was issued on 12 March 2020 adding COVID-19 test kits to the list of IVDs that require authorization from the FDA prior to their importation, distribution and sale.
FM No. 2020-006 was issued at the outset of the COVID-19 pandemic. Despite the limited clinical data available at that time to support the performance of the products, FM No. 2020-006 was issued requiring only limited documents to facilitate the issuance of Special Certification to provide access to these products and to enable testing of patients suspected to be afflicted with COVID-19.
Considering that developments have been made in establishing clinical data for COVID-19 test kits and there is already adequate supply of these products in the market, it is prudent to require compliance of these products to the FDA technical requirements for product registration similar with other regulated IVDs to ensure their quality, safety and performance. For COVID-19 test kits that have complied to the said technical requirements, it is appropriate to issue a Certificate of Product Registration (CPR) to the said test kit products in lieu of the Special Certification issued under FM 2020-006.
Majority of the above-mentioned IVDs including COVID-19 test kits are required to undergo performance evaluation by the FDA Common Services Laboratory (FDA-CSL) and by the different National Reference Laboratories (NRLs) depending on the respective capacity of said laboratories. These IVDs should pass such performance evaluation prior to the issuance of required authorization by the FDA.
II. OBJECTIVE
This Circular aims to:
A. Provide the specific list of the different registrable IVDs based on the capacity of FDA-CSL and NRLs.
B. Provide guidelines on the transition from the issuance of Special Certification to CPR for COVID-19 test kits and on the revised technical requirements for the registration of COVID-19 test kits
III. SCOPE
This Circular shall apply to manufacturers and distributors (importers/exporters/wholesalers) of registrable IVDs enumerated in Section B of FDA Memorandum Circular No. 2014-005 and of COVID-19 test kits and reagents.
IV. GUIDELINES
A. The following are the specific list of registrable IVDs that require performance evaluation based on the capacity of FDA-CSL and the different NRLs.
- FDA – CSL
a. Qualitative immunochromatographic assay Pregnancy Test Kits using urine specimen
- NRL – San Lazaro Hospital – STD AIDS Cooperative Central Laboratory
| TEST SYSTEM | TESTING PLATFORM | INTENDED USE |
| a. HIV (Antibody, antigen) | Screening Test, Confirmatory Test, Supplemental Test, Self-Testing* | Diagnostic Use Only |
| b. HBV (Antibody, antigen) | Screening Test, Confirmatory Test, Supplemental Test | Diagnostic Use Only |
| i. Hepatitis Markers (Antibody, antigen) | Screening Test, Disease Monitoring Test | Diagnostic Use Only |
| c. HCV (Antibody, antigen) | Screening Test, Confirmatory Test, Supplemental Test | Diagnostic Use Only |
| d. Syphilis (Treponemal, non-treponemal) | Screening Test, Confirmatory Test | Diagnostic Use Only |
| e. CD4 | Disease Monitoring Test | Diagnostic Use Only |
* Additional evaluation for HIV self-testing kits shall be done as community research study in coordination with the National AIDS and STD Prevention and Control Program (NASPCP) of the Department of Health.
- NRL – East Avenue Medical Center
| ANALYTE | IVD TYPE / SPECIMEN | CUT-OFF VALUES |
| a. Shabu (Methamphetamine) | Rapid Test Kits; Assay Reagents / Urine | 1000ng/mL; 500ng/mL
|
| b. Marijuana (THC) | Rapid Test Kits; Assay Reagents / Urine | 50ng/mL
|
| c. Amphetamine | Rapid Test Kits; Assay Reagents / Urine | 1000ng/mL; 500ng/mL |
| d. Cocaine/Benzoylecgonine | Rapid Test Kits; Assay Reagents / Urine | 300ng/mL
|
| e. Ecstasy (MDMA) | Rapid Test Kits; Assay Reagents / Urine | 500ng/mL
|
| f. Opiates (Morphine/Codeine) | Rapid Test Kits; Assay Reagents / Urine | 2000ng/mL
|
| g. Benzodiazepine (Nordiazepam/Oxazepam) | Rapid Test Kits; Assay Reagents / Urine | 300ng/mL |
- NRL – National Kidney and Transplant Institute
All platforms/technologies including but not limited to manual, semi-automated and automated platforms.
a. Anti-A Reagents
i. Anti-A1
ii. Anti-A2
iii. Anti-A3
iv. All other Anti-A Sub Types
v. Anti-A for Tube Technology
vi. Anti-A for Phase Contrast Technology
vii. Anti-A for Column Agglutination Technology
viii. Anti-A for Erythrocyte Magnetized Technology
ix. Anti-A for Solid Phase Technology
x. Anti-A Card Technology
xi. All other Anti-A Technologies
xii. Anti-A Control
xiii. Neutral reagents
xiv. Dolichos Biflorus Lectin (A1 Lectin) Reagent
xv. Anti-A,B
xvi. All other Anti-A reagents and controls
b. Anti-B Reagents
i. Anti-B
ii. All other Anti-B Sub Types
iii. Anti-B for Tube Technology
iv. Anti-B for Phase Contrast Technology
v. Anti-B for Column Agglutination Technology
vi. Anti-B for Erythrocyte Magnetized Technology
vii. Anti-B for Solid Phase Technology
viii. Anti-B Card Technology
ix. All other Anti-B Technologies
x. Anti-B Control
xi. Neutral reagents
xii. Anti-A,B
xiii. All other Anti-B reagents and controls
c. Anti-D/Rh Reagents
i. Anti-D/Rh
ii. Anti-DW
iii. Anti-DP
iv. Anti-DVI+
v. Anti-DVI-
vi. Anti-E
vii. Anti-e
viii. Anti-C
ix. Anti-c
x. Anti-CW
xi. All Other Anti-Rh Sub Types
xii. Anti-D/Rh For Tube Technology
xiii. Anti-D/Rh For Phase Contrast Technology
xiv. Anti-D/Rh For Column Agglutination Technology
xv. Anti-D/Rh For Erythrocyte Magnetized Technology
xvi. Anti-D/Rh For Solid Phase Technology
xvii. Anti-D/Rh Card Technology
xviii. All other Anti-D/Rh Technologies
xix. Anti-D/Rh Control
xx. Neutral reagents
xxi. All other Anti-D reagents and controls
d. Known Cells or Reverse Cells
i. Known A1 and Control
ii. Known A2 and Control
iii. Known B and Control
iv. Known O and Control
v. Neutral
vi. All other antigens for minor blood groups and controls
e. Anti-Human Globulin (AHG) Reagents
i. Polyspecific Anti-human Globulin
ii. Anti-IgG
iii. Anti-C3
iv. Anti-C3b
v. Anti-C3d
vi. Anti-C3d C3b
vii. Anti-C4b
viii. Anti-C4d
ix. All other anti complement antibodies
x. Coombs’ control
xi. Check cells
f. Potentiators
i. Low Ionic Strength Saline (LISS)
ii. LISS and Additives
iii. Albumin
iv. Albumin based additives
v. Enzymes (all Proteoloytic enzymes used in Immunohemotology included)
vi. Polyethelyne Glycol
vii. Polybrene
viii. Control
ix. Neutral
x. All other methods using potentiators
xi. All other technologies using potentiators
g. Antibody Screen Reagents
i. Pooled cells
ii. 2 cell antibody screen panel
iii. 3 cell antibody screen panel
iv. Antibody screen reagents for Tube method
v. Antibody screen reagents for Column Agglutination Technology
vi. Antibody screen reagents for Erythrocyte Magnetized Technology
vii. Antibody screen reagents for Solid Phase Method (Plate Method)
viii. LISS cards/cassettes for antibody screening using Column Agglutination Technology
ix. AHG cards/cassettes for antibody screening using Column Agglutination Technology
x. All other methods and technologies for antibody screening reagents and controls
xi. All other cards/cassettes for antibody screening reagents and controls
h. Antibody Identification Reagents
i. 11 or more cell antibody identification panel
ii. Antibody identification reagents for Tube method
iii. Antibody identification reagents for Column Agglutination Technology
iv. Antibody identification reagents for Erythrocyte Magnetized Technology
v. Antibody identification reagents for Solid Phase Method (Plate Method)
vi. LISS cards/cassettes for antibody identification using Column Agglutination Technology
vii. AHG cards/cassettes for antibody identification using Column Agglutination Technology
viii. All other methods and technologies for antibody identification reagents
ix. All other cards/cassettes for antibody identification reagents and controls
i. Phenotyping Reagents
i. Anti-C
ii. Anti-c
iii. Anti-Cw
iv. Anti-e
v. Anti-E
vi. Anti-Fya
vii. Anti-Fyb
viii. Anti-Jka
ix. Anti-Jkb
x. Anti-K
xi. Anti-k
xii. Anti-Kpa
xiii. Anti-Kpb
xiv. Anti-Lea
xv. Anti-Leb
xvi. Anti-M
xvii. Anti-N
xviii. Anti-P1
xix. Anti-S
xx. Anti-s
xxi. Anti-Lua
xxii. Anti-Lub
xxiii. Neutral card for Phenotyping
xxiv. Phenotyping reagents for Tube Method
xxv. Phenotyping reagents for Column Agglutination Technology
xxvi. Phenotyping reagents for Erythrocyte Magnetized Technology
xxvii. Phenotyping reagents for Solid Phase Method (Plate Method)
xxviii. LISS cards/cassettes for phenotyping using Column Agglutination Technology
xxix. AHG cards/cassettes for phenotyping using Column Agglutination Technology
xxx. Neutral cards/cassettes for phenotyping
xxxi. All other methods and technologies for phenotyping reagents
xxxii. All other cards/cassettes for antibody identification reagents
j. Miscellaneous Reagents
i. LISS cards/cassettes for crossmatching using column Agglutination Technology
ii. AHG cards/cassettes for crossmatching using column Agglutination Technology
iii. Crossmatching reagents using Erythrocyte Magnetized Technology
iv. Crossmatching reagents using Solid Phase Technology
v. All other reagents and methods used for crossmatching
vi. All other technologies for crossmatching
- NRL – Research Institute for Tropical Medicine
a. COVID-19 test kits and reagents
B. The following IVDs shall not undergo performance evaluation by the NRL but shall undergo documentary review by the FDA:
-
- Leptospirosis test kits/reagents
- Pregnancy test kits/reagents using specimen other than urine
C. Above-identified registrable IVDs including COVID-19 test kits shall comply with the FDA technical requirements for registration of IVDs (See Annex A).
D. IVDs including COVID-19 test kits that complied with the requirements shall be issued a CPR. The validity of CPR for COVID-19 test kits shall follow the existing validity of CPR for registrable IVDs.
E. The registration fee for COVID-19 test kits shall follow the registration fee for the registrable IVDs specified in FDA Memorandum Circular No. 2014-005:
- Php1,000.00 + 1% Legal Research Fee (LRF) for initial with one (1) year validity
- Php5,000.00 + 1% LRF for renewal with five (5) years validity
V. Separability Clause
In the event that any provision or part of this Circular is declared invalid, the other provisions hereof shall not be affected.
VI. REPEALING CLAUSE
Provisions of FM No. 2020-006 and FM No. 2021-009 entitled “Minimum Performance Requirements for COVID-19 Test Kits Used for SARS-CoV-2 Infection” that are inconsistent with this Circular are hereby modified, withdrawn, repealed, and/or revoked accordingly.
VII. TRANSITORY PROVISION
A. For COVID-19 test kits with pending application for initial Special Certification prior to the effectivity of this Circular, Special Certification shall still be issued for approved applications. However, after the validity of the issued Special Certification, CPR shall be required for the said COVID-19 test kits in accordance with this Circular.
B. For COVID-19 test kits with pending application for re-issuance of Special Certification pursuant to the provisions of FM No. 2021-009 prior to the effectivity of this Circular, Special Certification shall still be issued for approved applications. However, after the validity of the re-issued Special Certification, CPR shall be required for the said COVID-19 test kits in accordance with this Circular.
C. For COVID-19 test kits with valid Special Certification prior to the effectivity of this Circular, CPR shall be required for the said COVID-19 test kits after the expiration of the Special Certification. The Marketing Authorization Holder may apply for the CPR pursuant to this Circular six (6) months prior to the expiration of the Special Certification.
VIII. EFFECTIVITY
This Circular shall take effect fifteen (15) days following its publication in a newspaper of general circulation and upon filing three (3) certified true copies with the University of the Philippines Law Center – Office of the National Administrative Register.