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 For a complete listing, please see the Draft Guidance page.

Recent Draft Guidance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
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Interface (BCI) Devices for Patients with Paralysis or Amputation - Non-clinical Testing and Clinical Considerations - Draft Guidance for Industry and Food and Drug Administration Staff February 25, 2019
Nonbinding Feedback After Certain Food and Drug Administration Inspections of Device Establishments - Draft Guidance for Industry and Food and Drug Administration Staff February 19, 2019
Principles of Premarket Pathways for Combination Products February 06, 2019
Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products December 07, 2018
Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use - Draft Guidance for Industry and Food and Drug Administration Staff November 30, 2018
Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use - Draft Guidance for Industry and Food and Drug Administration Staff November 30, 2018
Recommendations for Dual 510(k) and CLIA Waiver by Application Studies - Draft Guidance for Industry and Food and Drug Administration Staff November 29, 2018
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Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices - Draft Guidance for Industry and Food and Drug Administration Staff November 29, 2018
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff October 18, 2018
The Special 510(k) Program - Draft Guidance for Industry and Food and Drug Administration Staff September 28, 2018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Recognition and Withdrawal of Voluntary Consensus Standards - Draft Guidance for Industry and Food and Drug Administration Staff September 14, 2018
510(k) Third Party Review Program - Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations September 14, 2018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Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions - Draft Guidance for Industry and Food and Drug Administration Staff September 06, 2018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
Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling - Draft Guidance for Industry and Food and Drug Administration Staff June 15, 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
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

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Page Last Updated: 02/22/2019
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