Medical Devices

Cross-Center Final Guidance

This page lists final guidance documents developed by CDRH and other FDA Centers. For a list of current draft guidance documents, please see the Draft Guidance page.

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Cross-Center Final Guidance Documents

TitleOrganizationDoc #Date
Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies - Guidance for Industry and Food and Drug Administration Staff (PDF - 1.1MB) CDRH CBER 1500626 09/12/17
Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 421KB) CDRH CBER 1500015 09/06/17
Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 532KB) CDRH CBER 1500012 08/31/17
FY 2018 Medical Device User Fee Small Business Qualification and Certification - Guidance for Industry, Food and Drug Administration Staff and Foreign Governments (PDF - 329KB) CDRH CBER 2017 08/29/17
Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities - Questions and Answers Guidance for Industry and Review Staff (PDF - 609KB) Procedural 01/18/17
Medical Product Communications That Are Consistent With the FDA-Required Labeling - Questions and Answers Guidance for Industry (PDF - 134KB) Procedural 01/17/17
Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions - Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators and Food and Drug Administration Staff (PDF - 749KB) CDRH CBER 1783 01/13/17
Medical Device Accessories - Describing Accessories and Classification Pathway for New Accessory Types - Guidance for Industry and Food and Drug Administration Staff (PDF - 512KB) CDRH CBER 1770 12/30/16
Postmarket Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 1.2MB) CDRH CBER 1400044 12/28/16
Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 286KB) CDRH CBER 1500044 08/30/16
Patient Preference Information - Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling - Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders (PDF - 766KB) CDRH CBER 1500006 08/24/16
Guidance for Industry and Food and Drug Administration Staff - Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications (PDF - 1.1MB) CDRH CBER 1772 08/24/16
Adaptive Designs for Medical Device Clinical Studies - Guidance for Industry and Food and Drug Administration Staff (PDF - 587KB) CDRH CBER 1500005 07/27/16
Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 367KB) CDRH CBER 1827 06/21/16
Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile - Guidance for Industry and Food and Drug Administration Staff (PDF - 386KB) CBER CDRH/ODE 1615 01/21/16
eCopy Program for Medical Device Submissions - Guidance for Industry and Food and Drug Administration Staff (PDF - 525KB) CDRH CBER 1797 12/03/15
Global Unique Device Identification Database (GUDID): Data Submission Compliance Date of September 24, 2015 - Guidance for Industry and Food and Drug Administration Staff (PDF - 199KB) CDRH CBER 1500036 08/14/15
Guidance for Industry and Food and Drug Administration Staff - Refuse to Accept Policy for 510(k)s (PDF - 1.2MB) CDRH CBER 1793 08/04/15
FY 2017 Medical Device User Fee Small Business Qualification and Certification - Guidance for Industry, Food and Drug Administration Staff and Foreign Governments (PDF - 765KB) CBER CDRH 2016 08/01/16
Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval - Guidance for Industry and Food and Drug Administration Staff (PDF - 500KB) CDRH CBER 1833 04/13/15
Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions - Guidance for Industry and Food and Drug Administration Staff (PDF - 800KB) CDRH CBER 1400007 04/13/15
Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff (PDF - 805KB) CDRH/ODE CBER 1748 03/17/15
Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 650KB) CDRH CBER 1400021 02/09/15
Mobile Medical Applications - Guidance for Industry and Food and Drug Administration Staff (PDF - 1.3MB) CDRH CBER 1741 02/09/14
Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex - Guidance for Industry and Food and Drug Administration Staff (PDF - 76KB) CDRH CDER CBER CVM 1768 12/02/14
Design Considerations for Devices Intended for Home Use - Guidance for Industry and Food and Drug Administration Staff (PDF - 523KB) CDRH CBER 1750 11/24/14
Molecular Diagnostic Instruments with Combined Functions - Guidance for Industry and Food and Drug Administration Staff (PDF - 425KB) CDRH/OIR CBER 1763 11/12/14
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 324KB) CDRH/ODE CDRH/OIR CBER 1825 10/02/14
Evaluation of Sex-Specific Data in Medical Device Clinical Studies - Guidance for Industry and Food and Drug Administration Staff (PDF - 941KB) CDRH CBER 1727 08/22/14
Unique Device Identifier System: Frequently Asked Questions, Vol. 1 - Guidance for Industry and Food and Drug Administration Staff (PDF - 462KB) CDRH CBER 1400050 08/20/14
FDA Decisions for Investigational Device Exemption Clinical Investigations - Guidance for Sponsors, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff (PDF - 631KB) CDRH CBER 1783 08/19/14
Unique Device Identification System: Small Entity Compliance Guide - Guidance for Industry and Food and Drug Administration Staff (PDF - 420KB) CDRH CBER 1400046 08/13/14
In Vitro Companion Diagnostic Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 159KB) CDRH CBER CDER 1737 08/06/14
The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] - Guidance for Industry and Food and Drug Administration Staff (PDF - 844KB) CDRH CBER 1766 07/28/14
Global Unique Device Identification Database (GUDID) - Guidance for Industry and Food and Drug Administration Staff (PDF - 2.8MB) CDRH/OSB CBER 1831 06/27/14
Providing Information about Pediatric Uses of Medical Devices - Guidance for Industry and Food and Drug Administration Staff CDRH CBER 1801 05/01/14
Types of Communication During the Review of Medical Device Submissions - Guidance for Industry and Food and Drug Administration Staff CDRH CBER 1804 04/04/14
Premarket Assessment of Pediatric Medical Devices - Guidance for Industry and Food and Drug Administration Staff CBER, CDRH/ODE 1220 03/24/14
Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff - Guidance for Industry and Food and Drug Administration Staff (PDF - 381KB) CDRH CBER 1677 02/18/14
Annual Reports for Approved Premarket Approval Applications (PMA) - Guidance for Industry and Food and Drug Administration Staff CBER CDRH 1585 02/10/14
Design Considerations for Pivotal Clinical Investigations for Medical Devices - Guidance for Industry, Clinical Investigators, Institutional Review Boards and Food and Drug Administration Staff CDRH CBER 1776 11/07/13
Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies - Guidance for Industry and Food and Drug Administration Staff (PDF - 1.3MB) CDRH CBER 1782 10/01/13
IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed 08/27/13
Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff CDRH/OSEL CBER 1618 08/14/13
Guidance for Industry: Oversight of Clinical Investigations - Risk-Based Approach to Monitoring (PDF - 174KB) Procedural 08/06/13
Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality (PDF - 60KB) Pharmaceutical Quality/Manufacturing Standards (CGMP) 06/25/13
Assay Migration Studies for In Vitro Diagnostic Devices - Guidance for Industry and FDA Staff (PDF - 1.2MB) CDRH/OIR, CBER 1660 04/25/13
Medical Device Classification Product Codes - Guidance for Industry and Food and Drug Administration Staff CDRH CBER 1774 04/11/13
Guidance for Industry and Food and Drug Administration Staff - User Fees and Refunds for Premarket Notification Submissions (510(k)s) CDRH CBER 1511 04/02/13
Guidance for Industry and Food and Drug Administration Staff - User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications CDRH CBER 1681 04/02/13
Financial Disclosure by Clinical Investigators (PDF - 165KB) Financial Disclosure by Clinical Investigators 02/01/13
Humanitarian Use Device (HUD) Designations - Guidance for Industry and FDA Staff (PDF - 141KB) Guidance for Industry and FDA Staff - Humanitarian Use Device (HUD) Designations 01/24/13
Guidance for Industry and Food and Drug Administration Staff - Acceptance and Filing Review for Premarket Approval Applications (PMAs) (PDF - 458KB) CDRH CBER 1792 12/31/12
IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed (Printer-Friendly) (PDF - 47KB) Draft Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed 08/27/13
Guidance for Industry and Food and Drug Administration Staff - FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals CBER CDRH 1208 10/15/12
Guidance for Industry and Food and Drug Administration Staff - FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals CBER CDRH 1219 10/15/12
FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act - Guidance for Industry and Food and Drug Administration Staff (PDF - 358KB) CDRH CBER 1671 04/06/12
Guidance for Industry and Food and Drug Administration Staff - User Fees for 513(g) Requests for Information CDRH CBER 1709 04/06/12
(Withdrawn) Guidance for Industry, Third Parties and Food and Drug Administration Staff - Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program CBER CDRH 1764 03/19/12
Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage (PDF - 157KB)
Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only - Guidance for Industry and Food and Drug Administration Staff CDRH CBER 1723 11/25/13
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
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
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
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
Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision CBER CDRH 1584 12/11/08
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
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
Significant Risk and Nonsignificant Risk Medical Device Studies - Information Sheet (PDF - 211KB) Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors - Significant Risk and Nonsignificant Risk Medical Device Studies 01/01/06
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices CBER CDRH/ODE CDRH/OIVD 337 05/11/05
Resolution of Disputes Concerning Payment or Refund of Medical Device User Fees Under MDUFMA CBER CDRH 1303 11/17/04
Premarket Approval Application Modular Review CBER CDRH/ODE 835 11/03/03
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

Page Last Updated: 09/11/2017
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