Bundling Multiple Devices or Multiple Indications in a Single Submission
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 on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.