Dive Brief:

• 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.

Dive Insight:

McCann told MedTech Dive the goal is to have the product cleared by FDA by the first or second quarter of 2020, but cautioned the company has "a good deal of learning to do in terms of the FDA response to this specific submission."

Somryst's submission is supported by two randomized controlled trials looking at whether an online insomnia program based on cognitive behavioral therapy is an effective intervention to reduce depression symptoms, according to Pear.

McCann said Pear made it a priority to overinvest in its relationship with FDA and in its own regulatory rigor as a participant in the Pre-Cert pilot program, noting both the agency and his company have been "in learning mode," throughout the pilot.

"I would suspect that our appraisal was probably a bit more fulsome and time consuming than what will wind up being the excellence appraisal," McCann said in an interview. "We did find the agency to be very concerned with software quality with methodology and ultimately with patient safety, which to my thinking is exactly their job."

Pear currently has two digital therapeutics products on the market: reSET, which aims to treat substance use disorder, and reset-O, which targets opioid use disorder.

McCann declined to discuss if any major commercial payers have agreed to cover the products, but said the company is "working with all of the major commercial payers, just to help them understand what this thing is, and ultimately how they will pay for it."

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."