Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Medtech Insight, in “Next Step in Global Convergence: FDA Looks to Make IMDRF Software Guidance Its Own,” by David Filmore.
Following is an excerpt:
FDA has not formally adopted any of those three guidance documents via its Good Guidance Practices process. And that is one thing, among several, that should make industry wary about the agency’s approach here, says attorney Bradley Thompson, who serves a general counsel to the Clinical Decision Support Coalition, an industry group heavily engaged in medical software regulation issues.
“In practical terms, this represents the adoption of not just one guidance, but four guidances. So, really, this initiative by FDA is extremely broad and covers nearly all aspects of standalone software regulation,” Thompson told Medtech Insight.
“FDA is proposing to adopt a document which the US FDA will not finalize. The IMDRF will finalize this document,” he noted. “The International Medical Device Regulators Forum frankly has no authority under US law. So I think there’s a problem with saying that this document – when finalized by an international body – will become US law.”
Thompson suggested it might be more appropriate if FDA solicited comments on the final version of the IMDRF guidance before adopting it as a final FDA guidance document. “Perhaps this will require two different comment periods,” he said.