Title 21

PART 607

Part 607 - Establishment Registration And Product Listing For Manufacturers Of Human Blood And Blood Products And Licensed Devices

PART 607 - ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS AND LICENSED DEVICES 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.

21:7.0.1.1.4.1SUBPART A
Subpart A - General Provisions
21:7.0.1.1.4.1.1.1SECTION 607.1
   607.1 Scope.
21:7.0.1.1.4.1.1.2SECTION 607.3
   607.3 Definitions.
21:7.0.1.1.4.1.1.3SECTION 607.7
   607.7 Establishment registration and product listing of blood banks and other firms manufacturing human blood and blood products.
21:7.0.1.1.4.2SUBPART B
Subpart B - Procedures for Domestic Blood Product Establishments
21:7.0.1.1.4.2.1.1SECTION 607.20
   607.20 Who must register and submit a blood product list.
21:7.0.1.1.4.2.1.2SECTION 607.21
   607.21 Times for establishment registration and blood product listing.
21:7.0.1.1.4.2.1.3SECTION 607.22
   607.22 How to register establishments and list blood products.
21:7.0.1.1.4.2.1.4SECTION 607.25
   607.25 Information required for establishment registration and blood product listing.
21:7.0.1.1.4.2.1.5SECTION 607.26
   607.26 Amendments to establishment registration.
21:7.0.1.1.4.2.1.6SECTION 607.30
   607.30 Updating blood product listing information.
21:7.0.1.1.4.2.1.7SECTION 607.31
   607.31 Additional blood product listing information.
21:7.0.1.1.4.2.1.8SECTION 607.35
   607.35 Blood product establishment registration number.
21:7.0.1.1.4.2.1.9SECTION 607.37
   607.37 Public disclosure of establishment registration and blood product listing information.
21:7.0.1.1.4.2.1.10SECTION 607.39
   607.39 Misbranding by reference to establishment registration, validation of registration, or to registration number.
21:7.0.1.1.4.3SUBPART C
Subpart C - Procedures for Foreign Blood Product Establishments
21:7.0.1.1.4.3.1.1SECTION 607.40
   607.40 Establishment registration and blood product listing requirements for foreign blood product establishments.
21:7.0.1.1.4.4SUBPART D
Subpart D - Exemptions
21:7.0.1.1.4.4.1.1SECTION 607.65
   607.65 Exemptions for blood product establishments.
21:7.0.1.1.4.5SUBPART E
Subpart E - Establishment Registration and Product Listing Of Licensed Devices
21:7.0.1.1.4.5.1.1SECTION 607.80
   607.80 Applicability of part 607 to licensed devices.