Working Out the Bugs: Congress Wants to Clarify FDA Software Regulation


Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, authored an article in Medical Device and Diagnostic Industry, titled “Working Out the Bugs: Congress Wants to Clarify FDA Software Regulation.”

Following is an excerpt:

The Medical Electronic Data Technology Enhancement for Consumers’ Health (MEDTECH) Act took a big step forward on April 27. In reintroducing the bill, Senators Michael Bennet (D–CO) and Orrin Hatch (R–UT) significantly improved the language.

The MEDTECH Act is intended to implement the recommendations of the Food and Drug Administration Safety Innovation Act Workgroup, which Senators Hatch and Bennet requested in the 2012 FDASIA legislation. That working group, which took the form of a federal advisory committee comprised of patients, consumers, health care providers, startup companies, health plans or other third-party payers, venture capital investors, and information technology vendors, spent the summer of 2013 developing the recommendations that led to this legislation.

Now you might think I’m suggesting that the bill became more industry friendly, since I represent industry and I am praising the changes. But actually the bill became a bit less industry friendly, not more. I am pleased not because the changes help industry, but rather because I recognize the changes reflect input from FDA and other stakeholders.

As much as we all like to complain about Congress and the legislation it produces, for any legislation to get serious consideration it needs to be the product of input from all stakeholders, reflecting sensible compromise. So revising the language based on input from FDA makes it far more likely that the MEDTECH Act will receive the broad support it needs for enactment.