| Title | Organization | Date |
|---|
| 2013 | | |
| Guidance for Industry and Food and Drug Administration Staff - User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications (This document supersedes “User Fees and Refunds for Premarket Approval Applications” dated November 24, 2003.) | CDER/CBER | April
2013 |
| | | |
| Guidance for Industry and Food and Drug Administration Staff - User Fees and Refunds for Premarket Notification Submissions (510(k)s)(This document supersedes “User Fees and Refunds for Premarket Notification Submissions (510(k)s)” issued August 27, 2009) | CDRH/CBER | April
2013 |
| 2011 | | |
Revised Draft Guidance: User Fee Waivers, Reductions, and Refunds for Drug and Biological Products(PDF - 256KB) (This guidance is a revision of the draft guidance entitled Draft Interim Guidance Document for Waivers of and Reductions in User Fees (1993 interim guidance), issued July 16, 1993). (Federal Register Notice: March 14, 2011) | CDER/CBER | March
2011 |
|
| 2010 | | |
| Draft Guidance for Industry and Investigators; Safety Reporting Requirements for INDs and BA/BE Studies (PDF - 687KB) | CDER/CBER | September 2010 |
| 2009 | | |
| Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (PDF - 316KB) | CDER/CBER/CDRH | September 2009 |
| | | |
| Guidance for Industry, FDA Staff, and Third Parties - Inspection by Accredited Persons Under The Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation Criteria (This document supersedes “Implementation of the Inspection by Accredited Persons Program Under The Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria,” issued on October 4, 2004. ) | CDRH/CBER | August 2009 |
| | | |
| Guidance for Industry and FDA Staff - User Fees and Refunds for Premarket Notification Submissions (510(k)s) (This document supersedes "User Fees and Refunds for Premarket Notification Submissions (510(k)s)" dated May 28, 2004. ) | CDRH/CBER | August 2009 |
| | | |
| Formal Meetings Between the FDA and Sponsors or Applicants (PDF - 89KB) (This guidance supersedes the guidance for industry Formal Meetings With Sponsors and Applicants for PDUFA Products published February 2000.) | CDER/CBER | May 2009 |
| | | |
| Guidance for Industry, FDA Staff, and FDA-Accredited Third Parties - Manufacturer's Notification of the Intent to Use an Accredited Person under the Accredited Persons Inspection Program Authorized by Section 228 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (This document supersedes the document which was issued on September 15, 2005 ) | CDRH/CBER | March 2009 |
| | | |
| Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices | CDER/CBER/CDRH/CVM | January 2009 |
| | | |
| 2004 | | |
| FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment | CDRH/CBER | May 2004 |
| | | |
| 2003 | | |
| Premarket Approval Application Modular Review (This document supersedes and replaces, "A Modular Approach to PMA Review," dated January 29, 1998, and "Guidance for the Medical Device Industry on PMA Shell Development and Modular Review," dated November 6, 1998.) | CDR/CBER | November 2003 |
| | | |
| Final Guidance for FDA Staff: The Leveraging Handbook; An Agency Resource for Effective Collaborations. (PDF - 143KB) | OC/CBER | June 2003 |
| | | |
