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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Draft Guidance Documents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
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Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Physician Notification Orders - Draft Guidance for Mammography Facilities and Food and Drug Administration Staff 07/21/20
Select Updates for Guidance for the Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH) - Draft Guidance for Industry and Food and Drug Administration Staff 07/14/20
Select Updates for Peripheral Vascular Atherectomy Devices - Premarket Notification [510(k)] Submissions - Draft Guidance for Industry and Food and Drug Administration Staff 07/13/20
Soft (Hydrophilic) Daily Wear Contact Lenses - Performance Criteria for Safety and Performance Based Pathway - Draft Guidance for Industry and Food and Drug Administration Staff 03/03/20
Product Labeling for Laparoscopic Power Morcellators - Draft Guidance for Industry and Food and Drug Administration Staff 02/26/20
Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use - Premarket Notification (510(k)) Submissions - Draft Guidance for Industry and Food and Drug Administration Staff 01/28/20
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Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions - Draft Guidance for Industry and Food and Drug Administration Staff 01/13/20
Magnetic Resonance (MR) Coil - Performance Criteria for Safety and Performance Based Pathway - Draft Guidance for Industry and Food and Drug Administration Staff 12/09/19
Breast Implants - Certain Labeling Recommendations to Improve Patient Communication - Draft Guidance for Industry and Food and Drug Administration Staff 10/24/19
Clinical Decision Support Software - Draft Guidance for Industry and Food and Drug Administration Staff 09/27/19
Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations - Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders 09/24/19
The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program - Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff 09/23/19
Cutaneous Electrodes for Recording Purposes - Performance Criteria for Safety and Performance Based Pathway - Draft Guidance for Industry and Food and Drug Administration Staff 09/20/19
Conventional Foley Catheters - Performance Criteria for Safety and Performance Based Pathway - Draft Guidance for Industry and Food and Drug Administration Staff 09/20/19
Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway - Draft Guidance for Industry and Food and Drug Administration Staff 09/20/19
Spinal Plating Systems - Performance Criteria for Safety and Performance Based Pathway - Draft Guidance for Industry and Food and Drug Administration Staff 09/20/19
Safer Technologies Program for Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff 09/19/19
Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment - Draft Guidance for Industry and Food and Drug Administration Staff 08/02/19
Surgical Staplers and Staples for Internal Use - Labeling Recommendations - Draft Guidance for Industry and Food and Drug Administration Staff 04/24/19
Technical Performance Assessment of Quantitative Imaging in Device Premarket Submissions - Draft Guidance for Industry and Food and Drug Administration Staff 04/19/19
Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol - 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
Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation - Non-clinical Testing and Clinical Considerations - Draft Guidance for Industry and Food and Drug Administration Staff 02/25/19
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
Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use - Draft Guidance for Industry and Food and Drug Administration Staff 11/30/18
Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use - Draft Guidance for Industry and Food and Drug Administration Staff 11/30/18
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff 10/18/18
Recognition and Withdrawal of Voluntary Consensus Standards - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 515KB) 09/14/18
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
Regulatory Considerations for Microneedling Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 441KB) 09/15/17
Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI) - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 384KB) 07/26/16
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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