Bradley Merrill Thompson Quoted in “Software Oversight Softened: FDA Nixes Medical Device Data Systems Enforcement”

The Gray Sheet

Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life, Sciences practice, in the Washington, DC, office, was quoted in an article titled "Software Oversight Softened: FDA Nixes Medical Device Data Systems Enforcement."

Following is an excerpt:

Three years after establishing a class 1 regulatory policy for software that passively stores, transfers, formats or displays medical device data, FDA says enough is enough.

So-called medical device data systems (MDDS) are already exempt from pre-market review. But software makers will now no longer even need to worry about the quality system regulation or other basic device requirements for the products, according to an FDA draft guidance (PDF)issued June 20.

While a 2011 rule establishing medical device data systems as class I medical devices (PDF)still formally stands in the code of federal regulations, the new draft guidance states that FDA no longer intends to enforce any regulatory controls on MDDS.

The agency cites "the low risk they pose to patients and the importance they play in advancing digital health" to support the new "enforcement discretion" policy. …

Ultimately, although there is no data on compliance rates, it is probably a mixed bag in terms of the proportion of MDDS makers that were complying with FDA's class I requirements up until now, says Bradley Thompson, an Epstein Becker Green attorney who coordinates several industry coalitions that engage with FDA on health IT regulatory issues.

"There was never very much incentive for complying even with the quality system requirements because pretty much everyone knew that companies that simply list with MDDS were not going to be inspected anytime soon," Thompson said in an interview. "At the same time, there are many ethical companies that were investing considerable time and energy in complying with the quality system requirements for MDDS. So those ethical companies will be relieved to know that they are not obligated to follow the quality system."

Thompson says he hopes FDA does not wait too long to issue a rule that makes this change truly official.

"I have to admit, as a nerdy lawyer, I'm pretty bothered that they are choosing to do this through a guidance document," he said. "On the one hand, I appreciate the desire for speed, but I hope they do follow this up with a rulemaking very quickly."