The FDA, sometimes referred to as the USFDA, stands for The Food and Drug Administration of the United States. Established in 1906 following the passage of the Federal Food and Drugs act, the FDA has become a critical part of Americas public health infrastructure and has expanded considerably in the past 100 years as cross-country border trade continues to rise. In addition to U.S.-based products, the FDA also regulates products that enter America from abroad.
Today, the FDA is responsible for regulating the safety, security, and effectiveness of many product types, including:
- Medical Devices
- Food (food additives, dietary supplements, infant formula, & bottled water)
- Radiation-emitting products
- Animal and veterinary products
- Tobacco Products
With all the above product types combined, the FDA regulates about 25% of all consumer expenditures across the United States every year. When it comes to PPE (Personal Protective Equipment), much of this equipment mandates approval by the FDA as they’re considered medical devices. Let’s explore how the FDA clears, authorizes, or regulates certain PPE using a risk-based approval process.
PPE Review & Approval Process
When a medical product, such as an N95 mask, is submitted for approval, the application generally takes about 6-10 months for the FDA to make a final call on whether the product is approved or not approved for medical use. During this review process, the FDA consults a branch of their institution called The Center for Devices and Radiological Health (CDRH) who’s job is to approve all medical devices sold in America. After a product has been approved and on the market, the FDA monitors feedback and medical events related to the product through several reporting tools, including:
- Safety Reporting Portal: A service that allows anyone to report safety issues from a variety of FDA approved products.
- MedWatch: Healthcare professionals and patients can report adverse events caused by medical devices, medications, food ingredients, and more.
- Vaccine Adverse Event Reporting System (VAERS): Not as much about medical devices, although this service allows healthcare professionals to report adverse reactions caused by vaccines.
- CFSAN Adverse Event Reporting System (CAERS): Not related to medical devices, anyone can report adverse reactions to foods, cosmetics, and dietary supplements.
Additionally, in rare cases, recalls for certain medical devices are issued by the FDA in hopes to protect consumer health. A product can be recalled for a variety of reasons, including mislabeling, contamination, adverse reactions, or just merited on the fact that it’s a defective product. When it comes to the FDA’s responsibility of approving medical devices, their website reads:
“FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.”
– U.S. Food & Drug Administration Website
Pacific Medical Products
Listed below are some of the FDA Approved medical masks available for purchase on our website:
We understand there’s a lot of concern about fake masks. We purchase all of our masks from Medline or McKesson (two of the world’s largest 3M distributors) who, by contract, can only buy them direct from the manufacturer. Every mask is 100% authentic with lot numbers that can be tracked back to the manufacturer. Quality and trust are of utmost importance to us at Pacific Medical Products.