The Federal Food and Drug Administration’s (FDA) Digital Health Software Precertification (Pre-Cert) Program, designed to expedite regulatory review for digital health apps that demonstrate quality and organizational excellence, is drawing criticism from some healthcare experts.
Theodore T. Lee, BA, from Yale University, and Aaron S. Kesselheim, MD, JD, MPH, from Brigham and Women’s Hospital and Harvard Medical School, provided expert comment in Annals of Internal Medicine, raising concerns that the program may not properly incentivize developers to review products regarding safety and efficacy before making them available to patients.
The program’s existence may lead patients and physicians to believe marketed products are rigorously evaluated, which may not be the case, they said in the commentary.
In addition, flexible regulation is essential, as apps are frequently updated. “Given limited resources, the FDA cannot review every health app undergoing constant iterations,” Mr. Lee and Dr. Kesselheim concluded. “However, for medical software devices that purport to diagnose or treat disease, adequate study of safety and effectiveness is needed at some point in their lifecycle regardless of developers’ internal quality processes. Without that, the Pre-Cert approach will ascribe FDA validation to more new products that have not established actual clinical benefits.”
|Lee TT, Kesselheim AS. U.S. Food and Drug Administration precertification pilot program for digital health software: weighing the benefits and risks. Ann Intern Med. April 10, 2018.