Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in MedTech Dive, in “Pear Files Insomnia and Depression Software as Pre-Cert Pilot 510(k),” by David Lim.

Following is an excerpt:

Pear Therapeutics said Thursday it filed what it believes is the first 510(k) product submission to FDA’s Software Precertification Pilot Program.

The device, Somryst, is a prescription digital therapeutic aiming to treat adult patients with chronic insomnia and symptoms of depression by using interventions to provide cognitive behavioral therapy for insomnia. The product, if cleared by FDA, would be the company’s third digital therapeutic on the market.

In May, Pear underwent the first-ever Excellence Appraisal as part of FDA’s 2019 Test Plan, according to CEO Corey McCann. Several appraisals, which aim to evaluate a company’s culture by examining staff workflow, effectiveness metrics and decision making, have since been completed with pilot participants, according to FDA. …

FDA said it will continue to evaluate the 2019 Test Plan to see if the results of the Pre-Cert pathway align with its traditional review system.

Bradley Merrill Thompson, an attorney at Epstein Becker Green, told MedTech Dive in an email he questions if FDA will be able to show that the Pre-Cert can produce adequate evidence it is as safe and effective as traditional review.

Thompson said he has no doubt FDA may declare the program to be “administratively feasible” by the end of the year, but that it is less clear if the pilot program will justify FDA going to Congress to get the legislative authority to permanently establish the program.

“It may be that they’re planning to use as a surrogate endpoint whether the same administrative decision is reached,” Thompson wrote. “But there certainly is no suggestion that the number of reviews they are doing will be statistically significant, or that they are taking other measures to assure the integrity of the data such as random sampling and blinding. It all seems very anecdotal and, in a statistical sense, biased.”

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