Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions - Draft Guidance for Industry and Food and Drug Administration Staff |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Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology - Draft Guidance for Industry and Food and Drug Administration Staff |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That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Draft Guidance for Industry and Food and Drug Administration Staff |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Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Draft Guidance for Industry and Food and Drug Administration Staff |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Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents - Draft Guidance for Industry and Food and Drug Administration Staff |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Content of Premarket Submissions for Device Software Functions - Draft Guidance for Industry and Food and Drug Administration Staff |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Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products - Draft Guidance for Industry and Food and Drug Administration Staff |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Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices - Draft Guidance for Industry and Food and Drug Administration Staff |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Electronic Submission Template for Medical Device 510(k) Submissions - Draft Guidance for Industry and Food and Drug Administration Staff |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Denture Base Resins – Performance Criteria for Safety and Performance Based Pathway - Draft Guidance for Industry and Food and Drug Administration Staff |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Facet Screw Systems – Performance Criteria for Safety and Performance Based Pathway - Draft Guidance for Industry and Food and Drug Administration Staff |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Remanufacturing of Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff |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Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order - Draft Guidance for Industry and Food and Drug Administration Staff |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Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act - Draft Guidance for Industry and Food and Drug Administration Staff |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 |