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GUIDANCE DOCUMENT

Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products Guidance for Industry and FDA February 2003

Final

Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products

Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

The Medical Device User Fee and Modernization Act of 2002 (MDUFMA), P.L. 107-250, amends the Federal Food, Drug, and Cosmetic Act (the act) to provide the Food and Drug Administration (FDA) new responsibilities, resources, and challenges. One particularly significant provision of MDUFMA is that which permits FDA to collect user fees for certain premarket reviews (i.e., premarket approval applications, premarket reports, supplements, premarket notifications, biologics license applications, and efficacy supplements as discussed in more detail below), including those applications received on or after October 1, 2002. On February 20, 2003, enabling appropriations were enacted, thus allowing the agency to immediately begin to collect fees for medical device applications.

FDA recently established a public docket to obtain input on the implementation of MDUFMA. (Docket number 02N-0534) The agency established this docket in order to provide an opportunity for all interested persons to provide information and share views on the various provisions of MDUFMA. However, FDA is implementing this Level 1 document upon issuance because it is essential for the agency to provide immediate guidance to help the industry determine the appropriate fees for their applications. FDA intends to review all comments it receives and issue a new guidance for public comment. In the meantime and until a new final guidance is issued, this document will be in effect. The agency is committed to obtaining input on the implementation of MDUFMA and encourages its stakeholders to participate in the process by commenting on this guidance and other MDUFMA provisions.


Submit Comments

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.