FDA releases final guidance for special 510(k) process

By AuntMinnie.com staff writers

September 12, 2019 -- The U.S. Food and Drug Administration (FDA) has released a final guidance on its Special 510(k) program.

The agency's previous guidance, "The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications," is replaced by this final document and the Abbreviated 510(k) Program document.

The FDA has also updated the following final guidance documents:

"Together, these guidance documents provide consistency, clarity, and transparency to industry and the FDA and may conserve resources for both, while still protecting public health, and not altering the statutory criteria for substantial equivalence," the agency said.

The FDA is holding a webinar on October 31 to discuss these guidances.

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