Manufacturers of some medical nonwovens have long had to participate in something called the 510(k) Review for the federal government. In August 2015, the FDA released a guidance document “Intent to Exempt Certain Unclassified, Class II and Class I Reserved Medical Devices from Premarket Notification Requirements: Guidance for Industry and Food and Drug Administration Staff.” This is a long title for a relatively simple idea: if a new or modified product is the same as something already on the market, it can be sold immediately. The concept was covered extensively in a recent article by Peter Mayberry in Nonwovens Industry.
Until this guidance document was issued, medical device manufacturers have had to participate in Premarket Notification (PMN) with the FDA. Manufacturers had to register with the FDA at least 90 days before bringing a new product to market. Some healthcare products made from nonwovens, including wound care items, feminine products and surgical drapes and gowns, were included in the PMN process.
Now, with the new guidance, if a product already exists on the market, manufacturers can basically take it to market immediately without going through the time and expense of the PMN.
While the new guidance is not an actual FDA rule, the FDA has said that it will no longer expect manufacturers to submit 510(k)s for any products that fit the existing product description.
This is good news for manufacturers of medical nonwovens and should cut down significantly on the hoops manufacturers must jump through to bring new products to market.
Maybe it’s a good time to start something new.