The Food and Drug Administration has been reviewing its 510(k) process, which is used for many medical device approvals. Two preliminary reports contain a series of recommendations designed to provide…
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About this Blog
The Healthy Skeptic is a website about the health care system, and is written by Kevin Roche, who has many years of experience working in the health industry. Mr. Roche is available to assist health care companies through consulting arrangements through Roche Consulting, LLC and may be reached at khroche@healthy-skeptic.com.