Updated monthly, the FDA 501(k) database is searchable by 501(k) number, applicant or device name, decision date and additional parameters. This database of new or significantly changed device information is submitted by medical device manufacturers prior to commercial distribution.
Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers to notify the FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification (PMN) or 510(k).
The Freedom of Information Action Online maintains a private library of more than 150,000 FDA documents in all categories of products regulated by the agency. It also includes a DocuSearch® system that can easily determine if the document is available to order.
Updated monthly, this database includes all PMAs, private licenses for marketing a medical device, approved by the FDA. Search the database by applicant name, trade name, docket number and additional parameters.
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