Medical Devices

Recent Final Medical Device Guidance Documents

This list contains the 25 most recent final medical device guidance documents. For a complete listing, please see the Guidance Documents homepage.

Recent Final Guidance Documents

TitleIssued Date
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
Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing - Guidance for Industry and Food and Drug Administration Staff (PDF - 345KB)09/20/18
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 364KB)09/14/18
Medical Device User Fee Small Business Qualification and Certification - Guidance for Industry, Food and Drug Administration Staff and Foreign Governments (PDF - 208KB)08/01/18
Logical Observation Identifiers Names and Codes for In Vitro Diagnostic Tests - Guidance for Industry and Food and Drug Administration Staff (PDF - 323KB)06/15/18
Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics - Guidance for Stakeholders and Food and Drug Administration Staff (PDF - 444KB)04/13/18
Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing (NGS) - Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases - Guidance for Stakeholders and Food and Drug Administration Staff (PDF - 869KB)04/13/18
Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions - Guidance for Industry and Food and Drug Administration Staff (PDF - 485KB)02/21/18
Acceptance and Filing Reviews for Premarket Approval Applications (PMAs) - Guidance for Industry and Food and Drug Administration Staff (PDF - 551KB)01/30/18
Refuse to Accept Policy for 510(k)s - Guidance for Industry and Food and Drug Administration Staff (PDF - 1.9MB)01/30/18
Medical Device Accessories - Describing Accessories and Classification Pathways - Guidance for Industry and FDA Staff (PDF - 449KB)12/20/17
Software as a Medical Device (SAMD): Clinical Evaluation - Guidance for Industry and Food and Drug Administration Staff (PDF - 1.2MB)12/08/17
Technical Considerations for Additive Manufactured Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 803KB)12/05/17
FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions - Guidance for Sponsors, Clinical Investigators, Industry, Institutional Review Boards, and Food and Drug Administration Staff (PDF - 573KB)12/05/17
Pediatric Information for X-ray Imaging Device Premarket Notifications - Guidance for Industry and Food and Drug Administration Staff (PDF - 672KB)11/28/17
Unique Device Identification: Direct Marking of Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 587KB)11/17/17
Product Labeling for Certain Ultrasonic Surgical Aspirator Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 273KB)10/30/17
De Novo Classification Process (Evaluation of Automatic Class III Designation) - Guidance for Industry and Food and Drug Administration Staff (PDF - 139KB)10/30/17
Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request - Guidance for Industry and Food and Drug Administration Staff (PDF - 269KB)10/30/17
Deciding When to Submit a 510(k) for a Software Change to an Existing Device - Guidance for Industry and Food and Drug Administration Staff (PDF - 585KB)10/25/17
Deciding When to Submit a 510(k) for a Change to an Existing Device - Guidance for Industry and Food and Drug Administration Staff (PDF - 1MB)10/25/17
User Fees for 513(g) Requests for Information - Guidance for Industry and Food and Drug Administration Staff (PDF - 83KB)10/02/17
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 (PDF - 396KB)10/02/17
User Fees and Refunds for De Novo Classification Requests - Guidance for Industry and Food and Drug Administration Staff (PDF - 419KB)10/02/17
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 - 423KB)10/02/17
User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications - Guidance for Industry and Food and Drug Administration Staff (PDF - 513KB)10/02/17
FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals - Guidance for Industry and Food and Drug Administration Staff (PDF - 485KB)10/02/17
FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals - Guidance for Industry and Food and Drug Administration Staff (PDF - 594KB)10/02/17
User Fees and Refunds for Premarket Notification Submissions (510(k)s) - Guidance for Industry and Food and Drug Administration Staff (PDF - 118KB)10/02/17
Display Devices for Diagnostic Radiology - Guidance for Industry and Food and Drug Administration Staff (PDF - 446KB)10/02/17
Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions - Guidance for Industry and Food and Drug Administration Staff (PDF - 440KB)09/29/17
Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A - Guidance for Industry and Food and Drug Administration Staff (PDF - 354KB)09/29/17
Administrative Procedures for CLIA Categorization - Guidance for Industry and Food and Drug Administration Staff (PDF - 124KB)10/02/17
Classification of Products as Drugs and Devices and Additional Product Classification Issues09/25/17

 

Page Last Updated: 11/02/2018
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