MDUFMA Guidances

Assessing User Fees

• 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

Bundling

• Bundling Multiple Devices or Multiple Indications in a Single Submission, June 22, 2007

Combination Products

• Draft Guidance for Industry and FDA Current Good Manufacturing Practice for Combination Products
• Guidance for Industry and FDA Staff: Application User Fees for Combination Products
• Definition of the Primary Mode of Action of a Combination Product
• Draft Guidance for Industry: Combination Products, Timeliness of Premarket Reviews, Dispute Resolution Guidance

Dispute Resolution

• Resolution of Disputes Concerning Payment or Refund of Medical Device User Fees Under MDUFMA - November 17, 2004

Expedited Review

• Expedited Review of Premarket Submissions for Devices, February 29, 2008

Inspections by an Accredited Person

• 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
• Implementation of the Inspection by Accredited Persons Program Under The Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria, October 4, 2004

Pediatric Medical Devices

• Premarket Assessment of Pediatric Medical Devices, May 14, 2004
• Pediatric Expertise for Advisory Panels, June 3, 2003

Premarket Notification Submissions (510(k)s)

• Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements, December 28, 2007
• User Fees and Refunds for Premarket Notification Submissions (510(k)s), May 28, 2004
• FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment, May 21, 2004
• Determination of Intended Use for 510(k) Devices, December 3, 2002

Premarket Approval Applications (PMAs)

• FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals, June 30, 2008
• Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements, December 28, 2007
• Real-Time Premarket Approval Application (PMA) Supplements
• User Fees and Refunds for Premarket Approval Applications, November 24, 2003
• Premarket Approval Application Modular Review, November 3, 2003
• Premarket Approval Application Filing Review, May 1, 2003

Reprocessed Single-Use Medical Devices

• 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

Section 301 (requirement to identify manufacturer on the device)

• 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