Subscribe

  • How Can We Help You?

    Global Problem Solving from Covington: Deal with Complex Problems Anywhere in the World

Concerns For 510(k) Sponsors After FDA Proposes Major Shift

Article September 18, 2023

Concerns For 510(k) Sponsors After FDA Proposes Major Shift

September 18, 2023, Law360

For several years, the U.S. Food and Drug Administration's Center for Devices and Radiological Health has been vocal about its views regarding the limitations of the 510(k) pathway and the need for modernization to keep up with advances in technology. In 2018, the CDRH proposed an approach that would sunset older predicates and promote the use of more modern predicates.

View More

Related Professionals

Share links:

Share links:

Related Practices

Related Industries

Related Offices

Related Regions

Related News & Insights