Tag Archives: 510k

Will a “Quik” 510(k) be a Quick 510(k)?

By Adrienne R. Lenz — On September 6, 2018, FDA launched the Quality in 510(k) Review Program Pilot (“Quik”). With the name “Quik,” it has a lot to live up to.  The goal of the program is to simplify the … Continue reading

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FDA Finalizes 510(k) Exemptions for Certain Class II Devices

By Allyson B. Mullen — On June 5, 2018, FDA published a notice in the federal register finalizing the 510(k) exemption for several devices. The proposed list for 510(k) exemption was published last November and included two new devices that … Continue reading

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510(k) Medical Device Review Process Reforms

FDA has issued a press release on its plan to reform the 510(k) medical device review process, outlining changes it intends to implement during 2011 including streamlining the "de novo" review process for certain innovative, lower-risk medical devices; clarifying when … Continue reading

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FDA Announces Plans to Reform 510(k) Process

This post was written by Jennifer A. Goldstein and Areta L. Kupchyk. On January 19, 2011, FDA announced its long-awaited plans for revising the premarket notification (510(k)) process for medical devices to address the concerns that have been raised about … Continue reading

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