21 CFR 807.20 - Who must register and submit a device list?
(1) Initiates or develops specifications for a device that is to be manufactured by a second party;
(2) Sterilizes or otherwise makes a device for or on behalf of a specifications developer or any other person;
(3) Repackages or relabels a device;
(4) Reprocesses a single use device that has previously been used on a patient;
(5) Acts as an initial importer as defined in § 807.3(g), except that initial importers may fulfill their listing obligation for any device for which they did not initiate or develop the specifications for the device or repackage or relabel the device by submitting the name and address of the manufacturer. Initial importers shall also be prepared to submit, when requested by FDA, the proprietary name, if any, and the common or usual name of each device for which they are the initial importer;
(6) Manufactures components or accessories that are ready to be used for any intended health-related purpose and are packaged or labeled for commercial distribution for such health-related purpose, e.g. blood filters, hemodialysis tubing, or devices which of necessity must be further processed by a licensed practitioner or other qualified person to meet the needs of a particular patient, e.g., a manufacturer of ophthalmic lens blanks.
(b) Registration or listing does not constitute an admission or agreement or determination that a product is a device within the meaning of section 201(h) of the Federal
(c) Registration and listing requirements shall not pertain to any person who acts as a wholesale distributor, as defined in § 807.3(t), and who does not manufacture, repackage, process, or relabel a device.
(d) Owners and operators of establishments or persons engaged in the recovery, screening, testing, processing, storage, or distribution of human cells, tissues, and cellular and tissue-based products, as defined in § 1271.3(d) of this chapter, that are regulated under the Federal
(e) Owners and operators of establishments that manufacture devices licensed under section 351 of the
Title 21 published on 09-Nov-2018 03:23
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 807 after this date.
- 21 CFR 807.35 — Notification of Registrant.
- 21 CFR 807.22 — Times for Establishment Registration and Device Listing.
- 21 CFR 1271.1 — What Are the Purpose and Scope of This Part?
- 21 CFR 807.65 — Exemptions for Device Establishments.
- 21 CFR 1271.20 — If My HCT/P's Do Not Meet the Criteria in § 1271.10, and I Do Not Qualify for Any of the Exceptions in § 1271.15, What Regulations Apply?