The US Food and Drug Administration’s medical device unit is considering seeking more legislative authority to strengthen its pre-market notification, or 510(k), process by which it clears the majority of low- and medium-risk devices1-3.
At a public meeting on the topic held on 18 February, the FDA officials listed the several challenges associated with the process identified over the past several years and made it clear that, in spite of industry claims that the process is working well4, there is definitely room for improvement...
Please login to read the full article.
