This script search US Code. View Rule
Menu Item - Home
Menu Item - Agenda Main page
Menu Item - Historical Agenda
Menu Item - Historical Agenda
Menu Item - Agenda Search
Menu Item - Agenda XML Reports
Menu Item - EO Dashboard
Menu Item - Reg Review
Menu Item - EO Agency lists
Menu Item - EO Search
Menu Item - EO Historical Reports
Menu Item - Review Counts
Menu Item - OIRA Letters
Menu Item - EOM 12866 Search
Menu Item - EO XML Reports
Menu Item - ICR Dashboard page
Menu Item - ICR Main page
Menu Item - ICR Search
Menu Item - ICR XML Reports
Menu Item - FAQ
Menu Item - Additional Resources
Menu Item - Contact Us
Search: Agenda Reg Review ICR

View Rule

View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML

HHS/FDA RIN: 0910-AF81 Publication ID: Spring 2007 
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 parts 210 and 211 will generally meet the requirements of the device quality system regulations in 21 CFR part 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
Action Date FR Cite
NPRM  11/00/2007    
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

About Us   Vertical Spacer Spacer Related Resources   Vertical Spacer Spacer Disclosure   Vertical Spacer Spacer Accessibility   Vertical Spacer Spacer Privacy Policy   Vertical Spacer Spacer Contact Us