Soumya Sen

May 9, 2023 | jamanetwork.com | Vinay K. Rathi |Alexander O. Everhart |Soumya Sen

To the Editor A recent study1 reported that 11% of the medical devices cleared via the 510(k) regulatory submission pathway experienced a class I or class II recall. Even though I share the concerns of Dr Everhart and colleagues1 about unsafe devices, I believe they may have underestimated the recall rate for devices cleared via the 510(k) process. Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance

May 9, 2023 | jamanetwork.com | Alexander O. Everhart |Yi Zhu |Ariel Stern |Soumya Sen

Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance—Reply In Reply Dr Rathi’s comments describe a fundamental challenge when studying 510(k) medical devices. Researchers can observe individual clearances, but when are devices actually different or new? Changes not related to device design that seem trivial ex ante could affect patient safety ex post.