The Food and Drug Administration (FDA or Agency) is proposing to amend its regulations concerning the classification of products as biological products, devices, drugs, or combination products, and their assignment to Agency components for premarket review and regulation. This proposed rule would update the regulations to clarify the scope of the regulations, streamline and clarify the appeals process, align the regulations with more recent legislative and regulatory measures, update advisory content, and otherwise clarify the regulations, including updates to reflect Agency practices and policies. These changes are intended to enhance regulatory clarity and efficiency.

Regulatory Impact Analysis

• Amendments to 21 CFR Part 3 - Product Jurisdiction (Proposed Rule) Regulatory Impact Analysis

Federal Register: 83 FR 22428, May 15, 2018

Docket: FDA-2004-N-0191