Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Healthcare IT News, in “FDA’s Second Draft Pre-Cert Released but Real Rule-Making Needed,” by Jonah Comstock.

Following is an excerpt:

The FDA continues to move at a fast pace to develop and, soon, implement its pre-certification program for medical software development. Yesterday the agency released a second draft of its Pre-Cert framework, incorporating some of the comments it received about the April first draft and seeking additional comments on other parts of the framework.

Epstein Becker Green’s Bradley Merrill Thompson expressed concerns in an email as the framework evolves, it’s beginning to raise questions about how the FDA will derive the authority to change the process of medical device regulation so drastically. It’s especially worrying given the agency hopes to have a pilot up and running by 2019.

“There is absolutely no way this program can go forward without changes at least two regulations, if not statute,” Thompson wrote. “The 510(k) regulation is pretty specific, and based on a pretty specific statute. None of the stuff that they are talking about doing in this precertification program is within the 510(k) regulation.”

Thompson sees this as part of a larger problem with how the FDA has been operating for some time around medical devices — overusing the concept of enforcement discretion to avoid real rulemaking. Similarly, he thinks the agency could be using the idea of a voluntary program in a similar way.

“The topic FDA really has not confronted is what it means for a program to be voluntary versus mandatory,” he said. “I assume that FDA believes that by making it voluntary, it can somehow adopt the program without changing the underlying statutes and regulations. As I said above, I don’t see how that’s possible. Even if it’s voluntary, the agency has to have statutory authority to do whatever it does. And this program has not been authorized by statute. Further, it expressly conflicts with the FDA’s own existing 510(k) in classification regulations. It cannot ignore statutes and regulations just by declaring that it’s a voluntary program.”

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