"510(k) cleared devices may have undergone insufficient testing due to: (1) lenient standards for 'substantial equivalence;' (2) device 'creep,' leading to unproven devices dissimilar from original predicates; and (3) use of unsafe or outdated predicates.
The FDA has been taking steps to modernize the 510(k) pathway for medical device approvals. In NEJM this week, Vinay Rathi and review how pathway has been problematic, and what more can be done to strengthen premarket testing (1/4)
Great article by Vinay Rathi and on the 510(k) pathway. Great potential for Real World Evidence to improve what we know about cleared and approved devices once they come on the market.
Kudos to the #FDA for taking steps towards modernizing the 510(k) Pathway