Jan 19, 2011

The US Food and Drug Administration (FDA) has rolled out the 510(k) premarket notification process for moderate-risk medical device clearance. The more polarizing aspects of the FDA’s plans, including establishing a new Class IIb device category requiring clinical information to support equivalence determinations as well as requiring postmarket surveillance studies as a condition of clearance for some devices, will not be finalized until after an independent report by the Institute of Medicine is issued later this year. Although the details that were announced by the FDA today warrant careful study by device manufacturers in order to comply, the most important elements of the agency’s reform plan remain unknown; manufacturers will have to maintain their wait-and-see (or wait-and-lobby) approach at least until midyear. What the FDA did disclose regarding its 510(k) reform plans included streamlining of its Class III de novo classification process, clarifying which instances require 510(k) applicants to submit clinical data during their review processes, and establishing a group of FDA experts, the Center Science Council, to develop consistent business processes and standard operating procedures. Action items covering improvement of clinical trial quality, 510(k) rescission appeals, and development and application of unique product codes will also be implemented by the FDA over the course of 2011. Whether or not the agency will also set up implementation timelines for its more challenging proposals remains unknown.


  • Stewart Eisenhart