September 2017 issue
September 30, 2017 | Vendors of digital health and software products used for diagnosing and treating psychological and neurological disorders will soon face a new regulatory framework set forth by the FDA. The new regulations could impact vendors of brain assessment systems and other neurodiagnostic tools that incorporate software modules.
FDA Commissioner Scott Gottlieb gave details of a new pre-certification pilot program for software as a medical device at the AdvaMed MedTech Conference in San Jose, CA earlier this month. Among the nine companies selected for the pilot program are Apple, Verily Life Sciences, Samsung, Fitbit, Johnson & Johnson, and Pear Therapeutics. The program’s approach is to oversee the digital health technology developer, rather than the software product itself. After reviewing systems for software design, validation and maintenance, the FDA will determine whether the company meets quality standards and if so, will precertify the company. With the information gleaned through the pilot program, the agency hopes to determine the key metrics and performance indicators for precertification and identify ways that precertified companies could potentially submit less information to the FDA than is currently required before marketing a new digital health tool as part of a formal program. The FDA is also considering, as part of the pilot program, whether and how, precertified companies may not have to submit a product for premarket review in some cases.
“Our method for regulating digital health products must recognize the unique and iterative characteristics of these products,” said Gottlieb. “We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate, and helps foster beneficial technology while ensuring that consumers have access to high-quality, safe, and effective digital health devices. These pilot participants will help the agency shape a better and more agile approach toward digital health technology that focuses on the software developer rather than an individual product.”
Recently, Pear Therapeutics became the first vendor of digital therapeutics to obtain FDA clearance. The company’s reSET product is a 12-week interval prescription therapeutic for substance use disorder to be used as an adjunct to standard, outpatient treatment. Pear’s pipeline includes products for opioid use disorder, schizophrenia, PTSD, general anxiety disorder, pain, major depressive disorder, and insomnia.
“This is a defining moment for digital therapeutics and for patients with substance use disorder,” said Corey McCann, president and CEO of Pear Therapeutics. “As the first FDA-cleared prescription digital therapeutic for disease treatment, reSET has demonstrated improved abstinence and treatment retention in a randomized controlled clinical study. We believe that prescription digital therapeutics hold promise in improving patient outcomes across a wide range of central nervous system disorders including psychiatry, neurology, and pain, and will become a vital part of tomorrow’s treatment paradigm across all disease areas. Pear was impressed by the collaborative approach the FDA took in reviewing this innovative technology.”
