The Food and Drug Administration (FDA) warns all concerned healthcare professionals and the public against the purchase and use of this unregistered medical device:
- Arturo Fixotherm SP-FT-001 Digital Fever Thermometer
The FDA verified through post-marketing surveillance that the abovementioned medical device is not registered and the Certificate of Product Registration (CPR) has not been issued. Pursuant to Republic Act 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization is prohibited.
Since this unregistered medical device has not gone through the evaluation process of the FDA, the agency cannot guarantee its quality and safety.
In light of the foregoing, the public is hereby advised not to purchase this violative product in the market.
All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device until the Certificate of Product Registration is issued, otherwise, regulatory actions and sanctions shall be strictly pursued.
All FDA Field Officers and Regulatory Enforcement Unit in coordination with the law enforcement agencies and Local Government Units are requested to ensure that this product is not sold or made available in their localities or areas of jurisdiction.
The Bureau of Customs is urged to restrain the entry of this unregistered product.
For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research through email at [email protected] or call (02) 857-1900 local 8301.
To report any sale or distribution of the above medical device, the online reporting facility, eReport, can be accessed at www.fda.gov.ph/ereport.
Dissemination of this advisory to all concerned is hereby requested.
Attachment-> : FDA Advisory No.2019-193