Mandates
Registration of Manufacturers
A US-located manufacturer, processor, packager (or reprocessor and repackager9) of a medical device must register with the FDA the business’s
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1Federal Food, Drug, and Cosmetic Act [hereinafter FFDCA] § 501(a)(1); 21 USC § 351(a)(1) (2006).
2FFDCA § 501(a)(4), 21 USC § 351(a)(4)(B) (2006).
3FFDCA § 501(a)(3), 21 USC § 351(a)(3) (2006).
4FFDCA § 501(e), 21 USC § 351(a)(1) (2006).
5FFDCA § 502(a), 21 USC § 352(a) (2006).
6FFDCA § 502(c), 21 USC § 352(c) (2006).
7FFDCA § 201(n), 21 USC § 321(n) (2006).
8FFDCA § 502(j), 21 USC § 352(j) (2006).
9Reprocessors and repackagers may sterilize, refurbish, or repackage previously used devices. There are special requirements for those who reprocess single-use medical devices. Section 502(v); 21 USC 352(v) (2006).
name and all places of business.10 Any additional place of business must be registered immediately.11 Registration is also required for establishments outside the United States where devices are made for importation into the United States.12 Registration is to be electronic.13
Listing of Products
Each registered person must file with the FDA a list identifying each device made or processed for commercial distribution in the United States.14 The label and labeling15 for each listed device and a representative sample of other labeling must be provided.16 The FDA may request a registrant to provide a statement as to why it believes that any product listed is not subject to a performance standard or a premarket approval (PMA) application requirement.17 If a device previously listed is no longer made, the registrant must provide a notice of discontinuance regarding the product.18 Listings are to be electronic.19
