Device Publications
Medical Devices Regulated by CBER
FDA Compliance Policy Guides - Sub Chapter 280: In Vitro Diagnostic Products - Reagents
Draft Guidance for Industry and FDA Staff: Assay Migration Studies for In Vitro Diagnostic Devices - 1/05/2009
Draft Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff: Humanitarian Device Exemption (HDE) Regulation: Questions and Answers - 8/7/2008
Guidance for Industry and FDA Staff: Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements - 3/7/2008
Guidance for Industry and FDA Staff: Expedited Review of Premarket Submissions for Devices - 3/7/2008
FEDERAL REGISTER Medical Devices; Hematology and Pathology Devices: Reclassification of Automated Blood Cell Separator Device Operating by Centrifugal Separation Principle; Final Rule - 11/30/2007
Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle - 11/29/2007
Draft Guidance for Industry and FDA Staff: In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions - 10/29/2007
Guidance for Industry, FDA, and Foreign Governments: Fiscal Year 2008 Medical Device User Fee Small Business Qualification and Certification (PDF - 1 MB) - 10/24/2007
Guidance for Industry and FDA Staff: Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions -
9/13/2007
FEDERAL REGISTER: Medical Devices: Immunology and Microbiology Devices: Classification of In Vitro Human Immunodeficiency Virus Drug Resistance Genotype Assay; Final Rule - 8/8/2007
Guidance for Industry: Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay - 8/8/2007
Draft Guidance for Industry, Clinical Laboratories, and FDA Staff: In Vitro Diagnostic Multivariate Index Assays - 7/24/2007
Guidance for Industry and FDA Staff: Bundling Multiple Devices or Multiple Indications in a Single Submission - 6/22/2007
Draft Guidance for Industry and FDA Staff: Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process - 3/26/2007
Draft Guidance for Industry and FDA Staff - Annual Reports for Approved Premarket Approval Applications (PMA) - 10/26/2006
Guidance for Industry and FDA Staff: Real-Time Premarket Approval Application (PMA) Supplements - 4/28/2006
FEDERAL REGISTER: Draft Guidance for Food and Drug Administration Reviewers: Premarket Notification Submissions for Automated Testing Instruments Used in Blood Establishments; Withdrawal of Guidance - 6/28/2005 - (PDF)
Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - 5/12/2005
Guidance for Industry and FDA Staff: Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use - 11/30/2004 - (PDF)
Guidance for Industry and FDA Staff: Resolution of Disputes Concerning Payment or Refund of Medical Device User Fees Under MDUFMA - 11/17/2004
Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Notification Submissions (510(k)s) - 5/28/2004 - (PDF)
Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment - 5/20/2004 - (PDF)
Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Approval Applications - 11/21/2003 - (PDF)
Guidance for Industry and FDA Staff: Premarket Approval Application Modular Review - 10/31/2003 - (PDF)
FEDERAL REGISTER Medical Devices; Immunology and Microbiology Devices; Classification of the West Nile Virus IgM Capture Elisa Assay - Final Rule - 10/30/2003 - (PDF)
Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Performance Assessment - 10/8/2003
Draft Guidance for Industry and FDA Staff: Premarket Assessment of Pediatric Medical Devices - 7/24/2003
Guidance for Industry and FDA Staff: Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices - 7/3/2003
Guidance for Industry and FDA Staff: Premarket Approval Application Filing Review - 5/1/2003
Guidance for Industry, FDA Staff, and Third Parties: Implementation of the Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria - 4/28/2003
Guidance for Industry and FDA Staff: Quality System Information for Certain Premarket Application Reviews - 2/3/2003
The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles; Final Guidance for FDA and Industry - 10/3/2002
Guidance for Industry: General Principles of Software Validation; Final Guidance for Industry and FDA Staff - 1/11/2002
Guidance for FDA Reviewers: Premarket Notification Submissions for Blood and Plasma Warmers - 7/19/2001
Guidance for FDA Reviewers: Premarket Notification Submissions for Transfer Sets (Excluding Sterile Connecting Devices) - 7/19/2001
Guidance for FDA Reviewers: Premarket Notification Submissions for Empty Containers for the Collection and Processing of Blood and Blood Components - 7/19/2001
Guidance for Industry: Revised Recommendations Regarding Invalidation of Test Results of Licensed and 510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors - 7/11/2001
Guidance for Industry: Use of Sterile Connecting Devices in Blood Bank Practices - 11/22/2000
Draft Guidance for Industry: Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis (OA) - 7/15/1999
Federal Register - FDA Modernization Act of 1997; List of Documents Issued by the FDA That Apply to Medical Devices Regulated by CBER - 4/26/1999 - (PDF)
Guidance for Industry: Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis - 2/17/1999
Federal Register - Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics and Devices; Final Rule 11/20/1998 - (PDF)
FEDERAL REGISTER: Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics and Devices; Proposed Rule - 6/8/1998 - (PDF)
FEDERAL REGISTER: Natural Rubber-Containing Medical Devices; User Labeling; Final Rule - 5/6/1998 - (PDF)
Related Information
CDRH FDAMA Guidances
Intercenter Agreement Between The Center for Biologics Evaluation and Research and The Center for Devices and Radiological Health - (PDF)
