Medical Devices

Recent Draft Medical Device Guidance Documents

This list contains the 25 most recent draft medical device guidance documents. For a complete listing, please see the Draft Guidance page.

Recent Draft Guidance

Title Date
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff October 18, 2018
The Special 510(k) Program - Draft Guidance for Industry and Food and Drug Administration Staff September 28, 2018
Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank September 20, 2018
Recognition and Withdrawal of Voluntary Consensus Standards - Draft Guidance for Industry and Food and Drug Administration Staff September 14, 2018
510(k) Third Party Review Program - Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations September 14, 2018
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Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions - Draft Guidance for Industry and Food and Drug Administration Staff September 06, 2018
Peripheral Vascular Atherectomy Devices - Premarket Notification [510(k)] Submissions - Draft Guidance for Industry and Food and Drug Administration Staff July 27, 2018
Metal Expandable Biliary Stents - Premarket Notification (510(k)) Submissions - Draft Guidance for Industry and Food and Drug Administration Staff July 18, 2018
Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings - Labeling Considerations - Draft Guidance for Industry and Food and Drug Administration Staff June 15, 2018
Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling - Draft Guidance for Industry and Food and Drug Administration Staff June 15, 2018
Humanitarian Device Exemption (HDE) Program - Draft Guidance for Industry and Food and Drug Administration Staff June 13, 2018
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program - Draft Guidance for Industry and Food and Drug Administration Staff June 07, 2018
Recommended Content and Format of Complete Test Reports for Non-Clinical Bench Performance Testing in Premarket Submissions - Draft Guidance for Industry and Food and Drug Administration Staff May 31, 2018
Multiple Function Device Products: Policy and Considerations - Draft Guidance for Industry and Food and Drug Administration April 27, 2018
Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56) - Draft Guidance for Industry and Food and Drug Administration Staff January 19, 2018
Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices - Draft Guidance for Industry and Food and Drug Administration Staff December 19, 2017
Investigational IVDs Used in Clinical Investigations of Therapeutic Products - Draft Guidance for Industry, Food and Drug Administration Staff, Sponsors, and Institutional Review Boards December 18, 2017
The Least Burdensome Provisions: Concept and Principles - Draft Guidance for Industry and Food and Drug Administration Staff December 15, 2017
Clinical and Patient Decision Support Software - Draft Guidance for Industry and Food and Drug Administration Staff December 08, 2017
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 December 08, 2017
Recommendations for Dual 510(k) and CLIA Waiver by Application Studies - Draft Guidance for Industry and Food and Drug Administration Staff November 29, 2017
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 November 29, 2017
Acceptance Review for De Novo Classification Requests - Draft Guidance for Industry and Food and Drug Administration Staff October 30, 2017
Breakthrough Devices Program - Draft Guidance for Industry and Food and Drug Administration Staff October 25, 2017
Marketing Clearance of Diagnostic Ultrasound Systems and Transducers - Draft Guidance for Industry and Food and Drug Administration Staff October 02, 2017

Page Last Updated: 06/12/2018
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