What 21 CFR Part 807 - Device Establishment Registration, Device Listing and 510(k) Premarket Notification requires
21 CFR Part 807 requires owners and operators of establishments engaged in the manufacture, preparation, propagation, compounding, assembly or processing of devices intended for human use to register their establishments with FDA and to list the devices they market, and it sets out the 510(k) premarket notification requirements. An establishment not otherwise exempt must register within 30 days of first entering into a covered operation, register annually during the period from October 1 to December 31 of each fiscal year, and update registration information within 30 days of any change. Registration and listing information must be submitted through FDA's electronic device registration and listing system unless a waiver is granted, and each owner or operator must maintain a historical file of labeling and advertisements. Foreign establishments that import or offer devices for import into the United States must register and identify importers and a United States agent. Except where exempt, a person required to register must submit a premarket notification (510(k)) to FDA at least 90 days before introducing a device into commercial distribution where the device is new, is being marketed by that person for the first time, or has been significantly changed; the submission must contain the information required, including the comparison establishing substantial equivalence. FDA reviews the submission and issues an order; the device may not be marketed until FDA determines it is substantially equivalent to a legally marketed predicate device.
Pillar: Medical & Healthcare · Authority: U.S. Food and Drug Administration (FDA) · Version: 1.0.0 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-807
SHA-256 integrity: 758a564ecd800b206359778bc99120009385e975e290a2591317e7a40ba37eb2
Primary Citations — 8 traced to source
- 21 CFR Part 807, §807.20 - who must register and submit a device list
- 21 CFR Part 807, §807.22 - times for establishment registration and device listing (initial within 30 days; annual October 1 to December 31)
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