21 CFR 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
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter F—Biologics
- Subpart A—General Provisions
- § 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.
- Subpart B—Procedures for Domestic Blood Product Establishments
- § 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.
- Subpart C—Procedures for Foreign Blood Product Establishments
- § 607.40 Establishment registration and blood product listing requirements for foreign blood product establishments.
- Subpart D—Exemptions
- § 607.65 Exemptions for blood product establishments.
- Subpart E—Establishment Registration and Product Listing Of Licensed Devices
- § 607.80 Applicability of part 607 to licensed devices.
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