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 Suggested Deregulation Affects Smart Scales, Fertility Thermometers, and More."
Following is an excerpt:
The US Food and Drug Administration has proposed to largely deregulate a sizable list of Class II and Class I medical devices and no longer require their makers to go through the 510(k) process. The agency made clear the deregulatory move would not necessarily exempt the device makers from other steps like appropriately registering and labeling their wares as medical devices or quality systems requirements. While the announcement is just a proposal and requires the usual public comment period and so on, the FDA said it would not enforce 510(k) requirements for the devices it listed and it doesn't expect companies making these devices to submit 510(k)s for them in the meantime.
"This is big news, and a huge boost to the [mobile health] industry," the mHealth Regulatory Coalition's Bradley Merrill Thompson wrote MobiHealthNews in an email. "It shows that FDA is being extremely practical in reviewing its own practices, and updating its regulatory requirements where the risks simply do not merit the investment of regulatory resources. My hat is off to FDA."
