Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Regulatory Affairs Professionals Society (RAPS), in “Experts Question Impact on Innovation, FDA Authority to Pursue Revamp of 510(k) Pathway,” by Ana Mulero.
Following is an excerpt:
Following Monday’s announcement from the US Food and Drug Administration (FDA) on its plans to remodel one of the review pathways for medical devices, industry trade associations pushed back on certain parts of the proposal that may hinder innovation. …
Statutory and regulatory authorities for pursuit of the policy changes has led turmoil among experts.
Bradley Merrill Thompson, an attorney at Washington-based law firm Epstein Becker Green, called the commitment set forth via the new medical device action plan on the alternative pathway “perhaps the most egregious example of violating the statute,” according to a recent comment submitted to FDA.
The 510(k) pathway “is the law of the land, and FDA doesn’t have the right to turn its back on the law and create a new system,” Thompson said. “The present system is the way that it is in part because of the concern over limiting agency authority due to its tendency to be unduly conservative an inherent subjectivity of decision-making. The system FDA describes has no limits on its own authority.”