N95 respirators intended for use in a health care setting during procedures to protect both the patient and health care personnel from the transfer of microorganisms, body fluids, and particulate material, are regulated under product code MSH, class II medical devices exempt from 510(k) Premarket Notification.
There are several exceptions.
■ intended to prevent specific diseases or infections
■ labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity
■ contains coating technologies unrelated to filtration (reduce and or kill microorganisms).
Under the Medical Device User Fee Amendments (MDUFA), medical device companies pay fees to the FDA when they register their establishments and list their devices.
$5,546.00 | Establishment Registration Fee, annual (FY 2021)
Keep in mind that this fee will increase on October 1, 2021.
Is your company manufacturing, exporting or distributing other medical devices?
FDA is using Dun & Bradstreet Inc to conduct verification of medical device facility information provided to the agency by registered and listed medical device manufacturers.
- Company Registration
- Product Listing
- U.S. Agent Service