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Draft Guidance for Industry and FDA Current Good Manufacturing Practice for Combination Products |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Draft Guidance for Industry: Combination Products, Timeliness of Premarket Reviews, Dispute Resolution Guidance |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 |
| |
Small Business Qualification
|
| |
FY 2010 MDUFMA Small Business Qualification Worksheet and Certification, August 3, 2009 |
| |
FY 2009 MDUFMA Small Business Qualification Worksheet and Certification, August 1, 2008 |
| |
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 |
