We have recently redesigned the FDA Web site. As a result, some Web links (URLs) embedded within guidance documents are no longer valid. If you find a link that does not work, please try searching for the document using the document title.
Draft Guidance Documents Title Issued Date Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency 01/07/25 Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations - Draft Guidance for Industry and Food and Drug Administration Staff 01/07/25 Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies - Draft Guidance for Industry and Food and Drug Administration Staff 01/07/25 Pulse Oximeters for Medical Purposes - Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations 01/07/25 The Accreditation Scheme for Conformity Assessment (ASCA) Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff 09/23/24 Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff 09/23/24 Biocompatibility Testing of Medical Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff 09/23/24 Chemical Analysis for Biocompatibility Assessment of Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff 09/20/24 Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle - Draft Guidance for Industry, Food and Drug Administration Staff, and Other Interested Parties 09/06/24 Predetermined Change Control Plans for Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff 08/22/24 Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564 - Draft Guidance for Laboratory Manufacturers and Food and Drug Administration Staff 05/06/24 Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency - Draft Guidance for Industry and Food and Drug Administration Staff 05/06/24 Animal Studies for Dental Bone Grafting Material Devices - Premarket Notification (510(k)) Submissions - Draft Guidance for Industry and Food and Drug Administration Staff 03/29/24 Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program - Draft Guidance for Industry and Food and Drug Administration Staff 03/15/24 Evaluation of Thermal Effects of Medical Devices that Produce Tissue Heating and/or Cooling - Draft Guidance for Industry and Food and Drug Administration Staff 03/15/24 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act - Draft Guidance for Industry and Food and Drug Administration Staff 03/13/24 Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance - Draft Guidance for Industry and Food and Drug Administration Staff 02/21/24 Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices - Draft Guidance for Industry and Food and Drug Administration Staff 01/23/24 Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices 12/19/23 Medical Devices with Indications Associated with Weight Loss - Clinical Study and Benefit-Risk Considerations - Draft Guidance for Industry and Food and Drug Administration Staff 09/14/23 Medical Devices with Indications Associated with Weight Loss - Non-Clinical Recommendations - Draft Guidance for Industry and Food and Drug Administration Staff 09/14/23 Evidentiary Expectations for 510(k) Implant Devices - Draft Guidance for Industry and Food and Drug Administration Staff 09/07/23 Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions - Draft Guidance for Industry and Food and Drug Administration Staff 09/07/23 Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission - Draft Guidance for Industry and Food and Drug Administration Staff 09/07/23 Patient-Matched Guides to Orthopedic Implants - Draft Guidance for Industry and Food and Drug Administration Staff 06/28/23 Photobiomodulation (PBM) Devices - Premarket Notification [510(k)] Submissions - Draft Guidance for Industry and Food and Drug Administration Staff 01/12/23 Computer Software Assurance for Production and Quality System Software - Draft Guidance for Industry and Food and Drug Administration Staff 09/13/22 Laser-Assisted In Situ Keratomileusis (LASIK) Lasers - Patient Labeling Recommendations 07/28/22 Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus - Draft Guidance for Industry and Food and Drug Administration Staff 05/20/21 Review and Update of Device Establishment Inspection Processes and Standards - Draft Guidance for Industry 03/29/19 Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 208KB) 08/17/18 Peripheral Vascular Atherectomy Devices - Premarket Notification [510(k)] Submissions - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 400KB) 07/27/18 Medical Product Communications That Are Consistent With the FDA-Required Labeling - Questions and Answers Guidance for Industry (PDF - 458KB) 06/12/18 Investigational IVDs Used in Clinical Investigations of Therapeutic Products - Draft Guidance for Industry, Food and Drug Administration Staff, Sponsors, and Institutional Review Boards (PDF - 731KB) 12/18/17 Acceptance Review for De Novo Classification Requests - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 1MB) 10/30/17 Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 1.1MB) 07/15/16 List of Highest Priority Devices for Human Factors Review - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 359KB) 02/03/16 Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use (PDF - 113KB) 10/21/15 Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 394KB) 03/22/16 Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Yersinia spp. Detection - Draft Guidance for Industry and Food and Drug Administration Staff 11/07/11 Presenting Risk Information in Prescription Drug and Medical Device Promotion (PDF - 933KB) 05/27/09
Content current as of:
01/06/2025
