Comment from Anonymous
AnonymousOpposeIndividual
Summary: The commenter expresses concern that exempting certain Class II medical devices from formal FDA premarket notification will lead to inconsistent performance and reliability. They argue that relying on manufacturer self-assessment could result in inaccurate data, leading to significant legal, safety, and compliance issues in federally regulated programs.
We have concerns about no formal FDA review of the performance data before marketing and they rely only on manufacturer self-assessment. There is a risk with undetected accuracy and reliability. Without premarket review devices could vary significantly in sensitivity and specificity. This could cause a lot of false positives or false negatives in federally regulated programs, affecting employment, legal, or safety decisions. This exemption can reduce regulatory burden and speed access for devices used in controlled Federal drug testing programs but this can cause less premarket validation, increased variability and misuse and legal and compliance ambiguity.