Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in POLITICO Morning eHealth, in “Congress Chugging Along,” by Darius Tahir.

Following is an excerpt:

Now, says Bradley Merrill Thompson — a lawyer with Epstein Becker & Green who works with digital health companies — there’s a lot of relatively low-risk software that could complement a device’s function. That’s why 21st Century Cures attempted to deregulate the category a bit by putting accessories into the “de novo” category.

The issue with that category, however, is that it takes a fair bit of work to earn approval, and once earned, moves the device into a lower-risk category. This means companies do a lot of work for later imitators to do much less.

Thompson says the Walters/Kuster bill attempts to combat the issue by creating a set of classifications, and allowing device companies to petition FDA that their accessory be slotted into an appropriate bucket. Those classifications would range from low-risk (and therefore low-scrutiny) to higher-risk.

That’s only of “modest benefit,” Thompson argues, since the bill ultimately defers to FDA to determine how much evidence is needed to slot a given device into a given category.

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