Assessing User Fees |
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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, February 25, 2003 |  |
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Bundling |
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Bundling Multiple Devices or Multiple Indications in a Single Submission, June 22, 2007 | |
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Combination Products |
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Draft Guidance for Industry and FDA Current Good Manufacturing Practice for Combination Products | |
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Guidance for Industry and FDA Staff: Application User Fees for Combination Products | |
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Definition of the Primary Mode of Action of a Combination Product | |
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Draft Guidance for Industry: Combination Products, Timeliness of Premarket Reviews, Dispute Resolution Guidance | |
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Dispute Resolution |
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Resolution of Disputes Concerning Payment or Refund of Medical Device User Fees Under MDUFMA - November 17, 2004 | |
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Expedited Review |
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Expedited Review of Premarket Submissions for Devices, February 29, 2008 | |
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Inspections by an Accredited Person |
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Requests for Inspection by an Accredited Person Under the Inspection by Accredited Persons Program Authorized by Section 201 of the Medical Device User Fee and Modernization Act of 2002 | |
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Implementation of the Inspection by Accredited Persons Program Under The Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria, October 4, 2004 | |
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Pediatric Medical Devices |
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Premarket Assessment of Pediatric Medical Devices, May 14, 2004 | |
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Pediatric Expertise for Advisory Panels, June 3, 2003 | |
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Premarket Notification Submissions (510(k)s) |
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Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements, December 28, 2007 | |
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User Fees and Refunds for Premarket Notification Submissions (510(k)s), May 28, 2004 | |
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FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment, May 21, 2004 | |
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Determination of Intended Use for 510(k) Devices, December 3, 2002 | |
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Premarket Approval Applications (PMAs) |
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Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements, December 28, 2007 | |
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Real-Time Premarket Approval Application (PMA) Supplements | |
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User Fees and Refunds for Premarket Approval Applications, November 24, 2003 | |
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Premarket Approval Application Modular Review, November 3, 2003 | |
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FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Performance Assessment, October 8, 2003 | |
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Premarket Approval Application Filing Review, May 1, 2003 | |
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Small Business Qualification |
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FY 2008 MDUFMA Small Business Qualification Worksheet and Certification, October 17, 2005 | |
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FY 2006 MDUFMA Small Business Qualification Worksheet and Certification, August 17, 2005 | |
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FY 2005 MDUFMA Small Business Qualification Worksheet and Certification, August 2, 2004 | |
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FY 2004 MDUFMA Small Business Qualification Worksheet and Certification, August 1, 2003 |
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Reprocessed Single-Use Medical Devices |
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Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices, September 25, 2006 | |
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Section 301 (requirement to identify manufacturer on the device) |
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Guidance for Industry and FDA Staff - Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended - Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices. May 1, 2006 | |
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Updated March 3, 2008
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