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  1. Device Advice: Comprehensive Regulatory Assistance

Recent Final Medical Device Guidance Documents

This list contains the most recent final medical device guidance documents. For a complete listing, please see the Guidance Documents homepage.

Recent Final Guidance Documents

Title Issued Date
The Special 510(k) Program - Guidance for Industry and Food and Drug Administration Staff 09/13/19
Format for Traditional and Abbreviated 510(k)s - Guidance for Industry and FDA Staff 09/13/19
The Abbreviated 510(k) Program - Guidance for Industry and Food and Drug Administration Staff 09/13/19
Refuse to Accept Policy for 510(k)s - Guidance for Industry and Food and Drug Administration Staff 09/13/19
Acceptance Review for De Novo Classification Requests - Guidance for Industry and Food and Drug Administration Staff 09/09/19
User Fees and Refunds for De Novo Classification Requests - Guidance for Industry and Food and Drug Administration Staff 09/09/19
FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals - Guidance for Industry and Food and Drug Administration Staff 09/09/19
Humanitarian Device Exemption (HDE) Program - Guidance for Industry and Food and Drug Administration Staff 09/05/19
Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions - Guidance for Industry and Food and Drug Administration Staff 08/30/19
Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications - Guidance for Industry and Food and Drug Administration Staff 08/30/19
Metal Expandable Biliary Stents - Premarket Notification (510(k)) Submissions - Guidance for Industry and Food and Drug Administration Staff 07/26/19
Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials - Guidance for Institutional Review Boards, Industry, Clinical Investigators, and Food and Drug Administration Staff 07/11/19
Center for Devices and Radiological Health (CDRH) Appeals Processes - Guidance for Industry and Food and Drug Administration Staff 07/02/19
Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A - Guidance for Industry and Food and Drug Administration Staff 07/02/19
Marketing Clearance of Diagnostic Ultrasound Systems and Transducers - Guidance for Industry and Food and Drug Administration Staff 06/27/19
Utilizing Animal Studies to Evaluate Organ Preservation Devices - Guidance for Industry and Food and Drug Administration Staff 05/08/19
Medical X-Ray Imaging Devices Conformance with IEC Standards - Guidance for Industry and Food and Drug Administration Staff 05/08/19
Policy Clarification for Certain Fluoroscopic Equipment Requirements - Guidance for Industry and Food and Drug Administration Staff 05/08/19
Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56) - Guidance for Industry and Food and Drug Administration Staff 05/08/19
Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 57) - Guidance for Industry and Food and Drug Administration Staff 05/08/19
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program - Guidance for Industry and Food and Drug Administration Staff 05/07/19
Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions - Guidance for Industry and Food and Drug Administration Staff 04/26/19
Unique Device Identification: Convenience Kits - Guidance for Industry and Food and Drug Administration Staff 04/26/19
Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices - Guidance for Industry and Food and Drug Administration Staff 04/26/19
Class II Special Controls Guideline: In Vitro Diagnostic Devices for Bacillus spp. Detection - Guideline for Industry and Food and Drug Administration Staff (PDF - 200.5KB) 04/01/19
Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) - Guidance for Industry and Food and Drug Administration Staff (PDF - 603kb) 03/13/19
Acceptance and Filing Reviews for Premarket Approval Applications (PMAs) - Guidance for Industry and Food and Drug Administration Staff (PDF - 583KB) 02/25/19
Refuse to Accept Policy for 510(k)s - Guidance for Industry and Food and Drug Administration Staff (PDF - 1.1MB) 02/25/19
Acceptance and Filing Reviews for Premarket Approval Applications (PMAs) - Guidance for Industry and Food and Drug Administration Staff (PDF - 551KB) 02/21/19
Evaluation of Devices Used with Regenerative Medicine Advanced Therapies - Guidance for Industry (PDF - 193KB) 02/15/19
Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements - Guidance for Industry and Food and Drug Administration Staff (PDF - 272KB) 02/08/19
The Least Burdensome Provisions: Concept and Principles - Guidance for Industry and FDA Staff (PDF - 484KB) 02/05/19
Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 372KB) 02/01/19
Safety and Performance Based Pathway - Guidance for Industry and Food and Drug Administration (PDF - 121KB) 01/21/19
Breakthrough Devices Program - Guidance for Industry and Food and Drug Administration Staff (PDF - 586KB) 12/18/18
Manufacturing Site Change Supplements: Content and Submission - Guidance for Industry and Food and Drug Administration Staff (PDF - 185KB) 12/17/18
User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications - Guidance for Industry and Food and Drug Administration Staff (PDF - 151KB) 12/12/18
Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking - Immediately in Effect Guidance for Industry and Food and Drug Administration Staff (PDF - 375KB) 11/05/18
Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics - Guidance for Industry and Food and Drug Administration Staff (PDF - 538KB) 09/25/18