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: New Guidance Underscores Flexible Oversight of Low-Risk Devices.”
Following is an excerpt:
FDA is touting newly released guidance on medical device data systems as further evidence it will use enforcement discretion in its regulatory oversight of low-risk devices, such as medical device data systems. But some stakeholders following the issue are upset the agency proposed the flexible approach to MDDS through guidance instead of rulemaking.
The agency issued regulation in 2011 downclassifying device data systems from class III to class I. In the “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices” draft guidance issued Friday (June 20), FDA further proposes applying a regulatory approach to those products that would rely on enforcement discretion.
“Since down-classifying MDDS, the FDA has gained additional experience with these type of technologies, and has determined that these devices pose a low risk to the public. Therefore, the FDA does not intend to enforce compliance with the regulatory controls that apply to MDDS devices, medical image storage devices, and medical image communications devices,” the guidance reads. …
Bradley Merrill Thompson, an attorney at Epstein, Becker & Green, said FDA should be applauded for its efforts to focus on high-risk devices and de-regulate low-risk products like medical device data systems, but by issuing the proposal through guidance the agency is forcing companies to decide whether they want to risk violating existing regulations or stick to their ethics and lose out on commercial opportunities.
Thompson, who also leads several industry coalitions, said that’s a sloppy way to regulate, adding that there is still a regulation “on the books” that needs to be changed. Thompson also said FDA, by not amending the regulation, was creating a dilemma for manufacturers.
“Every company has to decide am I going to take a risk and ignore the regulation based on a guidance document,” he noted.