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 “FDA Draft Proposes No Regulation of Medical Device Data Systems.”
Following is an excerpt:
The FDA won’t enforce regulations on computer systems used to store, display or collect medical data because they pose a low risk to patients, according to a draft guidance released June 20.
The Food and Drug Administration in the guidance said it wouldn’t enforce compliance with any of its previous regulatory controls on the products, called medical device data systems (MDDS). The result should be a reduced burden for developers, the agency said.
“The FDA is issuing this draft guidance document to inform manufacturers, distributors, and other entities that the agency does not intend to enforce compliance with the regulatory controls that apply to MDDS, medical image storage devices, and medical image communications devices, due to the low risk they pose to patients and the importance they play in advancing digital health,” the agency said in the draft. …
Bradley Merrill Thompson, an attorney with Epstein Becker & Green in Washington and co-founder of the mHealth Regulatory Coalition, told Bloomberg BNA June 20 the guidance should be welcomed by manufacturers.
“There’s no reason to waste industry, or FDA resources on really low-risk technology,” Thompson said. “It’s de-regulatory in an area where compliance didn’t really add any protections. I applaud FDA for taking this step.”
However, Thompson said he wasn’t sure why the FDA decided to issue a draft guidance, instead of just amending the regulations in a rule.
“There’s a regulation on the books that needs to be changed,” Thompson said. A guidance document is nonbinding, and merely expresses the FDA’s current opinions on a particular topic. “It’s a sloppy way to regulate,” he said.
A rulemaking process is more formal, and the agency is able to respond to comments with a proposed rule, Thompson said. “I appreciate the desire for speed, but I hope they do follow this up with a rulemaking very quickly.”