Logo Image
|Articles|August 4, 2011

Poll of the Week: Should the FDA's 510(k) Process be Scrapped?

Should the process be scrapped? Vote here, and tell us what you think.

The Institute of Medicine recently recommended that the FDA abandon the current 510(k) clearance process for medical devices, saying the current attempts at a revision aren’t sufficient to protect patients or industry.

The device industry, which supports the FDA’s 25-step plan to improve the process, disagreed, saying the FDA’s efforts should continue. The FDA disagreed with the recommendation, but said the agency was open to proposals for improvement of the device review programs.

Should the process be scrapped? Vote here, and tell us what you think.

Related to this article

View more
Key Sessions of Interest for Radiologists at the Upcoming HLTH USA Conference
Key Sessions of Interest for Radiologists at the Upcoming HLTH USA Conference
How will generative AI software be evaluated by the FDA in the future? What’s next for point-of-care ultrasound? What steps have been successful in facilitating adoption of AI applications across enterprise systems? Leaders in radiology and health care will be discussing these topics and more at the upcoming HLTH USA conference.
Read more