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Medical Device User Fee and Modernization Act of 2002
Establishment of a Public Docket, 12/31/02
Docket Number 02N-0534

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The FDA has established a public docket to obtain input on implementation of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Federal Register Notice - 2/4/2003). This provides an opportunity for all interested persons to provide information and share views on the implementation of MDUFMA. A copy of the statute and other information on implementation is available on the Center's MDUFMA website at http://www.fda.gov/cdrh/mdufma/index.html.

Written comments can be submitted to Dockets Management Branch, (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD, 20852 or electronic comments to http://www.accessdata.fda.gov/scripts/oc/dockets/commentdocket.cfm . Be sure to include the docket number 02N-0534 with your comments.

At this time the agency is particularly interested in receiving comments from stakeholders about several provisions that must be immediately implemented to track and monitor the performance goals FDA has pledged to meet over the next few years and to collect appropriate fees. Specifically, the Agency is seeking input on:

  1. more clearly defining the different supplement submissions such as: “panel-track supplement,” “180-day supplement,” and “real-time supplement.”
  2. implementing the modular review program for PMA’s,
  3. establishing a bundling policy to define when bundling multiple devices, device modifications, or indications for use into a single submission is appropriate versus when separate applications should be submitted; and
  4. gathering information for the pediatric device guidance document
FDA’s MDUFMA Steering Committee is specifically seeking input on items 1 and 3 above as soon as possible. To expedite this request we are asking that you send your comments, including the Docket Number 02N-0534, to the MDUFMA email address MDUFMA@cdrh.fda.gov. The comments will be forwarded to the Docket.

 

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Web page created April 15, 2003