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GUIDANCE DOCUMENT

Bundling Multiple Devices or Multiple Indications in a Single Submission Guidance for Industry and FDA Staff June 2007

Final
Docket Number:
FDA-2003-D-0376
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

The Medical Device User Fee and Modernization Act of 2002 (MDUFMA), P.L. 107-250, amended the Federal Food, Drug, and Cosmetic Act (the act) by authorizing FDA to collect user fees for certain premarket submissions received on or after October 1, 2002. A letter from the Secretary of Health and Human Services to Congress that accompanies the user fee legislation sets forth performance goals and policy and procedural provisions. One of these provisions is entitled, “Bundling Policy,” and states that FDA will consider, in consultation with its stakeholders, when bundling multiple devices in a single submission may be appropriate.

This guidance is intended to assist industry and FDA staff in understanding when bundling may be appropriate.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2003-D-0376.