Cross-Center Guidance Document List

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Draft Guidance for Industry and Food and Drug Administration Staff - Medical Device Classification Product Codes	CDRH CBER	1774	01/03/12
Draft Guidance for Industry and Food and Drug Administration Staff - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]	CDRH/ODE CBER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Draft Guidance- Humanitarian Use Device (HUD) Designations (PDF - 79KB)	FDA Staff- Humanitarian Use Device (HUD) Designations; HDE, HUD
Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff - FDA Decisions for Investigational Device Exemption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Draft Guidance for Industry and Food and Drug Administration Staff - De Novo Classification Process (Evaluation of Automatic Class III Designation)	CDRH CBER	1760	10/03/11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Draft Guidance for Industry and Food and Drug Administration Staff - Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review	CDRH CBER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Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff - Design Considerations for Pivotal Clinical Investigations for Medical Devices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Draft Guidance for Industry and Food and Drug Administration Staff - Mobile Medical Applications	CDRH CBER	1741	07/21/11
Draft Guidance for Industry and Food and Drug Administration Staff - In Vitro Companion Diagnostic Devices	CDRH CBER CDER	1737	07/14/11
Draft Guidance for Industry and FDA Staff - Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked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