Part 607 — Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices
Current through Sep 8, 2026
Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 371, 374, 381, 393; 42 U.S.C. 262, 264, 271.
Source: 40 FR 52788, Nov. 12, 1975, unless otherwise noted.
Sections
- § 607.1 Scope.
- § 607.3 Definitions.
- § 607.7 Establishment registration and product listing of blood banks and other firms manufacturing human blood and blood products.
- § 607.20 Who must register and submit a blood product list.
- § 607.21 Times for establishment registration and blood product listing.
- § 607.22 How to register establishments and list blood products.
- § 607.25 Information required for establishment registration and blood product listing.
- § 607.26 Amendments to establishment registration.
- § 607.30 Updating blood product listing information.
- § 607.31 Additional blood product listing information.
- § 607.35 Blood product establishment registration number.
- § 607.37 Public disclosure of establishment registration and blood product listing information.
- § 607.39 Misbranding by reference to establishment registration, validation of registration, or to registration number.
- § 607.40 Establishment registration and blood product listing requirements for foreign blood product establishments.
- § 607.65 Exemptions for blood product establishments.
- § 607.80 Applicability of part 607 to licensed devices.