Device User Fees
This article was originally published in RAJ Devices
Executive Summary
FDA begins collecting FY 2003 MDUFMA fees and establishes docket
FDA begins collecting FY 2003 MDUFMA fees and establishes docket
US legislation has been enacted which sets out fiscal year (FY) 2003 appropriations for the FDA (see Table 1)1. Although FY 2003 began on 1 October 2002, the delayed enactment of FY 2003 appropriations legislation providing for the new medical device fees under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) meant that the FDA could not yet begin collecting the fees2,3.
FDA publishes payment instructions
Now that the FDA is authorised to begin collecting device user fees, the agency has published a notice in the Federal Register announcing that it will issue invoices for all fees payable for applications submitted between 1 October 2002 and 31 March 20034. Those invoices will be due and payable within 30 days of issuance. For all applications submitted on or after 1 April 2003, fees must be paid at the time that applications are submitted to the FDA. The notice also provides payment procedures for those subject to user fees.
MDUFMA docket
A public docket has been established by the FDA in order to obtain input on implementation of MDUFMA 5. Although the agency invites comments on any or all aspects of the law, it is particularly interested in receiving comments on the following issues, as several MDUFMA provisions must be implemented immediately to track and monitor the performance goals FDA has pledged to meet over the next few years:
- defining the various types of PMA supplements;
- implementing the modular review programme for PMAs;
- establishing a bundling policy to determine when it is appropriate to bundle multiple devices, device modifications or indications for use into a single submission; and
- gathering information for the paediatric device guidance document.
The FDA hopes that this docket will become an important tool for receiving information from interested parties and for public availability of that information. Furthermore, the agency expects to use its MDUFMA website www.fda.gov/cdrh/mdufma to request input to the docket from stakeholders on a variety of specific questions and issues related to MDUFMA. Electronic comments regarding MDUFMA may be submitted to www.fda.gov/dockets/ecomments and should be identified with docket number 02N-0534.
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Food and Drug Administration: $1 630 727 000 Center for Devices and Radiological Health 208 685 000 Center for Drug Evaluation and Research 426 671 000 Center for Biologics Evaluation and Research 199 699 000 Center for Food Safety and Applied Nutrition 413 347 000 Center for Veterinary Medicine 88 972 000 National Center for Toxilogical Research 40 688 000 Other 252 665 000 |
References
1. P.L. 108-7, Consolidated Appropriations Resolution, 2003, Sponsor Rep CW Bill Young, 108th Congress, 20 February 2003, www.house.gov
2. P.L. 107-250, Medical Device User Fee and Modernization Act of 2002, Sponsor Rep James C Greenwood, 107th Congress, www.house.gov; The Regulatory Affairs Journal (Devices), 2002, 10 (4), 339-342
3.The Regulatory Affairs Journal (Devices), 2003, 11 (1), 42
4.Federal Register, 25 February 2003, 68 (37), 8773-8774
5.Federal Register, 4 February 2003, 68 (23), 5643-5644