Cross-Center Guidance Document List

Posted on February 21, 2012. Filed under: Uncategorized |

Title Organization Doc # Date
Providing Submissions in Electronic Format — Standardized Study Data (PDF – 539KB) Electronic Submissions 02/17/12
Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage (PDF – 157KB)
Draft Guidance for Industry and Food and Drug Administration Staff – Medical Device Classification Product Codes CDRH CBER 1774 01/03/12
Draft Guidance for Industry and Food and Drug Administration Staff – The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] CDRH/ODE CBER 1766 12/27/11
Draft Guidance- Humanitarian Use Device (HUD) Designations (PDF – 79KB) FDA Staff- Humanitarian Use Device (HUD) Designations; HDE, HUD
Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff – FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations CDRH CBER 1783 11/10/11
Draft Guidance for Industry and Food and Drug Administration Staff – De Novo Classification Process (Evaluation of Automatic Class III Designation) CDRH CBER 1760 10/03/11
Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring (PDF – 149KB) Procedural 08/29/11
Draft Guidance for Industry and Food and Drug Administration Staff – Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review CDRH CBER 1772 08/15/11
Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff – Design Considerations for Pivotal Clinical Investigations for Medical Devices CDRH/ODE CDRH/OIVD CBER 1776 08/15/11
Guidance for Industry and Food and Drug Administration Staff and Foreign Governments – FY 2012 Medical Device User Fee Small Business Qualification and Certification (PDF – 1.5MB) CDRH CBER 2012 08/01/11
Guidance for Industry and FDA Staff – 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device CDRH CBER 1793 07/27/11
Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Applications CDRH CBER 1741 07/21/11
Draft Guidance for Industry and Food and Drug Administration Staff – In Vitro Companion Diagnostic Devices CDRH CBER CDER 1737 07/14/11
Draft Guidance for Industry and FDA Staff – Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions CDRH/OIVD CBER 1723 06/01/11
Draft Guidance for Industry and FDA Staff – Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling CDRH/ODE CBER 1644 05/02/11
Guidance for Industry and FDA Staff – 30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes CDRH/OC CBER 1687 04/13/11
Electronic Source Documentation in Clinical Investigations (PDF – 166KB) Procedural; Electronic Submissions 01/06/11
Guidance for Industry: Cellular Therapy for Cardiac Disease CBER/CDRH 11/04/10
Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff – Humanitarian Device Exemption (HDE) Regulation: Questions and Answers CBER CDRH 1668 07/08/10
Guidance for Industry and FDA Staff: In Vitro Diagnostic (IVD) Device Studies – Frequently Asked Questions (PDF – 352KB) CBER CDRH/OIVD 1587 06/25/10
Draft Guidance for Industry, Third Parties and FDA Staff: Medical Device ISO 13485:2003 Voluntary Audit Report Submission Program CBER CDRH 1705 05/20/10
Draft Guidance for Industry and FDA Staff: FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act ODE/POS/PNS 1671 04/29/10
Draft Guidance for Industry and FDA Staff: User Fees for 513(g) Requests for Classification Information ODE/POS/PNS 1709 04/29/10
Guidance for Industry and FDA Staff – User Fees and Refunds for Premarket Notification Submissions (510(k)s) CBER CDRH 1511 08/27/09
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 CBER CDRH 1200 08/06/09
Presenting Risk Information in Prescription Drug and Medical Device Promotion (PDF – 387KB) Advertising 05/27/09
User Fees and Refunds for Premarket Approval Applications CBER CDRH 1681 03/13/09
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) CBER CDRH 1532 03/02/09
Assay Migration Studies for In Vitro Diagnostic Devices CBER CDRH/OIVD 1660 01/05/09
Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile CBER CDRH/ODE 1615 12/12/08
Modifications to Devices Subject to Premarket Approval (PMA) – The PMA Supplement Decision CBER CDRH 1584 12/11/08
FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals CBER CDRH 1218 06/30/08
Coronary Drug-Eluting Stents-Nonclinical and Clinical Studies  (PDF – 398KB)
Coronary Drug-Eluting Stents — Nonclinical and Clinical Studies -Companion Document (PDF – 221KB)
Guidance for Industry and FDA Staff: Expedited Review of Premarket Submissions for Devices CBER CDRH 108 02/29/08
Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements CBER CDRH 1655 02/28/08
Guidance for Industry and FDA Staff: Bundling Multiple Devices or Multiple Indications in a Single Submission CBER CDRH 1215 06/22/07
Guidance on Pharmacogenetic Tests and Genetic Tests for Heritable Markers CBER CDER CDRH 1549 02/09/06
Annual Reports for Approved Premarket Approval Applications (PMA) CBER CDRH 1585 10/26/06
Real-Time Premarket Approval Application (PMA) Supplements CBER CDRH 673 04/28/06
Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable CBER CDRH 1588 04/25/06
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices CBER CDRH/ODE CDRH/OIVD 337 05/11/05
Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use CBER CDRH 4444 11/30/04
Resolution of Disputes Concerning Payment or Refund of Medical Device User Fees Under MDUFMA CBER CDRH 1303 11/17/04
Guidance for Industry and FDA Staff – User Fees and Refunds for Premarket Notification Submissions (510(k)s) CBER CDRH 1511 08/27/09
FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment CBER CDRH 1219 05/21/04
Premarket Assessment of Pediatric Medical Devices CBER CDRH 1220 05/14/04
Guidance for Industry and FDA: User Fees and Refunds for Premarket Approval Applications CBER CDRH 1224 11/24/03
Premarket Approval Application Modular Review CBER CDRH/ODE 835 11/03/03
Premarket Approval Application Filing Review CBER CDRH/ODE CDRH/OIVD 297 05/01/03
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 CBER CDRH 1201 02/25/03
The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles; Final Guidance for FDA and Industry CBER CDRH/ODE 1332 10/04/02
General Principles of Software Validation; Final Guidance for Industry and FDA Staff CBER CDRH/OC 938 01/11/02

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