FDA Issues Three Guidances on Premarket Notification [510(k)] Program 

On September 7, 2023, the U.S. Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) issued three new draft guidance documents addressing premarket notification [510(k)] submissions for medical devices: 

• Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission (Docket Number: FDA-2023-D-3134);  
• Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions (Docket Number: FDA-2023-D-3133); and  
• Evidentiary Expectations for 510(k) Implant Devices (Docket Number: FDA-2023-D-3132).   

These draft guidances are part of the FDA’s ongoing efforts to modernize the 510(k) Program (described in its Medical Device Safety Action Plan) as it implements the Medical Device User Fee Amendments 2022 (MDUFA V). The FDA believes these guidances will enhance the predictability, consistency, and transparency of 510(k) review. 

The FDA has said that its effort to modernize the 510(k) Program is borne out of a recognition that there is a need to improve the safety and effectiveness of medical devices as they become more complex and innovative while continuing to bring critical devices to patients. 

On October 26, 2023, from 1:00 PM – 2:30 PM ET, the FDA will host a webinar for device manufacturers and other stakeholders to describe the FDA’s ongoing efforts to modernize the 510(k) Program, to provide an overview of the three new draft guidances, and to respond to questions. 

The FDA is accepting public comments on the draft guidances at www.regulations.gov (under the docket numbers listed above) through December 6, 2023, so that the FDA can consider comments before it begins work on the final versions of the guidances. CBSA will work with our national partners to evaluate and provide comments on these draft guidances. If you would like to share any comments or concerns with CBSA, please reach out to Amy Goodman, CBSA Vice President and Counsel for Policy + Advocacy. 

CBSA Co-Signs Letters Urging Actuarial Review of Biomarker Testing Coverage Bill 

CBSA has co-signed two letters to the Colorado General Assembly’s leadership requesting that the American Cancer Society Cancer Action Network’s (ACS CAN’s) biomarker testing coverage bill (introduced in 2023 as HB23-1110) be prioritized for the actuarial review required by SB22-040 so the bill can move forward in 2024. 

In 2023, CBSA supported HB23-1110, which would have required insurance coverage for biomarker testing supported by nationally recognized clinical practice guidelines for diagnosis, treatment, and disease management. The 2023 bill failed to move forward because it had not yet undergone the SB22-040 actuarial review process for new insurance mandates conducted by the Division of Insurance. 

CBSA is continuing to work with a coalition led by ACS CAN to try to remove barriers to biomarker testing to ensure that patients can unlock the value and cost-savings potential of precision medicine.