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  1. Guidance Documents (Medical Devices and Radiation-Emitting Products)

Draft Medical Device Guidance

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Draft Guidance Documents

Title Issued Date
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In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564 - Draft Guidance for Laboratory Manufacturers and Food and Drug Administration Staff 05/06/24
Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency - Draft Guidance for Industry and Food and Drug Administration Staff 05/06/24
Animal Studies for Dental Bone Grafting Material Devices - Premarket Notification (510(k)) Submissions - Draft Guidance for Industry and Food and Drug Administration Staff 03/29/24
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program - Draft Guidance for Industry and Food and Drug Administration Staff 03/15/24
Evaluation of Thermal Effects of Medical Devices that Produce Tissue Heating and/or Cooling - Draft Guidance for Industry and Food and Drug Administration Staff 03/15/24
Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act - Draft Guidance for Industry and Food and Drug Administration Staff 03/13/24
Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance - Draft Guidance for Industry and Food and Drug Administration Staff 02/21/24
Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices - Draft Guidance for Industry and Food and Drug Administration Staff 12/23/24
510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review - Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations 12/21/23
Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices 12/19/23
Select Updates for the 506J Guidance: 506J Device List and Additional Notifications - Draft Guidance for Industry and Food and Drug Administration Staff 11/17/23
Electronic Submission Template for Medical Device De Novo Requests - Draft Guidance for Industry and Food and Drug Administration Staff 09/29/23
Medical Devices with Indications Associated with Weight Loss - Clinical Study and Benefit-Risk Considerations - Draft Guidance for Industry and Food and Drug Administration Staff 09/14/23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
Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder - Draft Guidance for Industry and Food and Drug Administration Staff 07/28/23
Patient-Matched Guides to Orthopedic Implants - Draft Guidance for Industry and Food and Drug Administration Staff 06/28/23
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions - Draft Guidance for Industry and Food and Drug Administration Staff 04/03/23
Orthopedic Non-Spinal Bone Plates, Screws, and Washers - Premarket Notification (510(k)) Submissions - Draft Guidance for Industry and Food and Drug Administration Staff 03/29/23
Photobiomodulation (PBM) Devices - Premarket Notification [510(k)] Submissions - Draft Guidance for Industry and Food and Drug Administration Staff 01/12/23
Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers - Draft Guidance for Industry and Food and Drug Administration Staff 12/09/22
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
Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment - Draft Guidance for Industry and Food and Drug Administration Staff 12/17/18
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
 
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