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

Draft Medical Device Guidance

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Draft Guidance Documents

Title Issued Date
Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions - Draft Guidance for Industry and Food and Drug Administration Staff 12/23/21
Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology - Draft Guidance for Industry and Food and Drug Administration Staff 12/23/21
Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Draft Guidance for Industry and Food and Drug Administration Staff 12/23/21
Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Draft Guidance for Industry and Food and Drug Administration Staff 12/23/21
Referencing the Definition of "Device" in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents - Draft Guidance for Industry and Food and Drug Administration Staff 12/16/21
Content of Premarket Submissions for Device Software Functions - Draft Guidance for Industry and Food and Drug Administration Staff 11/04/21
Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products - Draft Guidance for Industry and Food and Drug Administration Staff 10/20/21
Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices - Draft Guidance for Industry and Food and Drug Administration Staff 10/14/21
Electronic Submission Template for Medical Device 510(k) Submissions - Draft Guidance for Industry and Food and Drug Administration Staff 09/29/21
Denture Base Resins – Performance Criteria for Safety and Performance Based Pathway - Draft Guidance for Industry and Food and Drug Administration Staff 08/30/21
Facet Screw Systems – Performance Criteria for Safety and Performance Based Pathway - Draft Guidance for Industry and Food and Drug Administration Staff 08/30/21
Remanufacturing of Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff 06/24/21
Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order - Draft Guidance for Industry and Food and Drug Administration Staff 05/27/21
Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act - Draft Guidance for Industry and Food and Drug Administration Staff 05/27/21
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
Electromagnetic Compatibility (EMC) of Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff 11/17/20
Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin - Draft Guidance for Industry and Food and Drug Administration Staff 10/15/20
Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Physician Notification Orders - Draft Guidance for Mammography Facilities and Food and Drug Administration Staff 07/21/20
Soft (Hydrophilic) Daily Wear Contact Lenses - Performance Criteria for Safety and Performance Based Pathway - Draft Guidance for Industry and Food and Drug Administration Staff 03/03/20
Product Labeling for Laparoscopic Power Morcellators - Draft Guidance for Industry and Food and Drug Administration Staff 02/26/20
Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions - Draft Guidance for Industry and Food and Drug Administration Staff 01/13/20
Clinical Decision Support Software - Draft Guidance for Industry and Food and Drug Administration Staff 09/27/19
Technical Performance Assessment of Quantitative Imaging in Device Premarket Submissions - Draft Guidance for Industry and Food and Drug Administration Staff 04/19/19
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
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff 10/18/18
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
Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 615KB) 12/19/17
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
Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 1.4MB) 05/13/16
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
General Considerations for Animal Studies for Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 418KB) 10/14/15
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
Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) - Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories (PDF - 312KB) 10/03/14
FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs) - Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories (PDF - 565KB) 10/03/14
Surveying, Leveling, or Alignment Laser Products - Draft Guidance for Industry and Food and Drug Administration Staff 05/05/14
Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products - Draft Guidance for Industry and Food and Drug Administration Staff 11/07/13
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
Coronary Drug-Eluting Stents — Nonclinical and Clinical Studies -Companion Document (PDF - 1.3MB) 04/07/08
Coronary Drug-Eluting Stents-Nonclinical and Clinical Studies (PDF - 1.7MB) 03/26/08
Draft Guidance for Industry, Clinical Laboratories, and FDA Staff - In Vitro Diagnostic Multivariate Index Assays 07/26/07
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