U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Device Advice: Comprehensive Regulatory Assistance
  4. Guidance Documents (Medical Devices and Radiation-Emitting Products)
  5. Draft Medical Device Guidance
  1. Device Advice: Comprehensive Regulatory Assistance

Draft Medical Device Guidance

Draft Medical Device Guidance

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 As a result, some Web links (URLs) embedded within guidance documents are no longer valid.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Draft Guidance Documents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
Clinical Investigations for Prostate Tissue Ablation Devices - Draft Guidance for Industry and Food and Drug Administration Staff 06/26/19
Surgical Staplers and Staples for Internal Use - Labeling Recommendations - Draft Guidance for Industry and Food and Drug Administration Staff 04/24/19
Technical Performance Assessment of Quantitative Imaging in Device Premarket Submissions - Draft Guidance for Industry and Food and Drug Administration Staff 04/19/19
Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol - Draft Guidance for Industry and Food and Drug Administration Staff 04/19/19
Review and Update of Device Establishment Inspection Processes and Standards - Draft Guidance for Industry 03/29/19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Interface (BCI) Devices for Patients with Paralysis or Amputation - Non-clinical Testing and Clinical Considerations - Draft Guidance for Industry and Food and Drug Administration Staff 02/25/19
Nonbinding Feedback After Certain Food and Drug Administration Inspections of Device Establishments - Draft Guidance for Industry and Food and Drug Administration Staff 02/19/19
Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment - Draft Guidance for Industry and Food and Drug Administration Staff 12/17/18
Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use - Draft Guidance for Industry and Food and Drug Administration Staff 11/30/18
Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use - Draft Guidance for Industry and Food and Drug Administration Staff 11/30/18
Recommendations for Dual 510(k) and CLIA Waiver by Application Studies - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 1.4MB) 11/29/18
Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 800KB) 11/29/18
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff 10/18/18
The Special 510(k) Program - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 697KB) 09/28/18
Recognition and Withdrawal of Voluntary Consensus Standards - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 515KB) 09/14/18
510(k) Third Party Review Program - Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations (PDF - 781KB) 09/14/18
Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 616KB) 09/06/18
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
Metal Expandable Biliary Stents - Premarket Notification (510(k)) Submissions - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 507KB) 07/18/18
Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings - Labeling Considerations - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 347KB) 06/15/18
Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 460KB) 06/15/18
Humanitarian Device Exemption (HDE) Program - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 1.2MB) 06/13/18
Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers Guidance for Industry (PDF - 458KB) 06/12/18
Multiple Function Device Products: Policy and Considerations - Draft Guidance for Industry and Food and Drug Administration (PDF - 472KB) 04/27/18
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
Clinical and Patient Decision Support Software - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 461KB) 12/08/17
Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 547KB) 12/08/17
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
Premarket Notification (510(k)) Submissions for Bone Anchors - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 493KB) 01/03/17
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
Electroconvulsive Therapy (ECT) Devices for Class II Intended Uses - Draft Guidance for Industry, Clinicians and Food and Drug Administration Staff (PDF - 315KB) 12/29/15
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
Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 357KB) 12/22/14
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