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HHS/FDA

RIN: 0910-AF81

Publication ID: Fall 2006

Title: Current Good Manufacturing Practice for Combination Products
Abstract: The proposed rule would clarify and streamline the current good manufacturing practice (cGMP) requirements for combination products (combinations of a drug, device, and/or biological product). The proposed rule would provide a flexible, quality management regulatory framework that recognizes that, in most instances, for combination products, a properly implemented quality system program under one set of medical product cGMP regulations will meet the requirements of another set (e.g., application of cGMPs for finished pharmaceuticals in 21 CFR 210/211 will generally meet the requirements of the device quality system regulations in 21 CFR 820). It would allow manufacturers the flexibility to select either the cGMP or quality system regulation to apply for the manufacture of their combination product, provided that their system incorporates select, key provisions from the regulations pertaining to the other part of their combination product. It would avoid the necessity to fully implement both sets of cGMP regulations when manufacturing combination products. The proposed rule is intended to ensure consistency and appropriateness in the regulation of combination products.
Agency: Department of Health and Human Services(HHS)	Priority: Other Significant
RIN Status: Previously published in the Unified Agenda	Agenda Stage of Rulemaking: Proposed Rule Stage
Major: Undetermined	Unfunded Mandates: No
CFR Citation: 21 CFR 4, subchapter A (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 21 USC 321 21 USC 331 21 USC 351 21 USC 352 21 USC 353 21 USC 355 21 USC 360 21 USC 360c to 360f 21 USC 360h to 360j 21 USC 360l 21 USC 360hh to 360ss 21 USC 360aaa to 360bbb 21 USC 371a 21 USC 372 to 374 21 USC 379e 21 USC 381 21 USC 394 42 USC 216 42 USC 262 42 USC 263a 42 USC 264 42 USC 271

Legal Deadline: None

Timetable:

Action	Date	FR Cite
NPRM	03/00/2007

Regulatory Flexibility Analysis Required: No	Government Levels Affected: None
Small Entities Affected: Businesses	Federalism: No
Included in the Regulatory Plan: No
Agency Contact: James S. Cohen Senior Counsel Department of Health and Human Services Food and Drug Administration Office of Combination Products, Suite 200 (HFG-3), 15800 Crabbs Branch Way, Rockville, MD 20855 Phone:301 427-1934 Fax:301 427-1935 Email: james.cohen@fda.hhs.gov