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FDA Attorney

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The attorneys are skeptical. “Startups have been the lifeblood of the medical technology industry for decades,” Bradley Merrill Thompson, a health-care attorney at Epstein Becker & Green PC in Washington, told Bloomberg Law. Current regulatory frameworks have let many startups down, Thompson said, and the proposed pilot program expansion may not be able to relieve regulatory confusion fast enough. The pilot program, run by the Food and Drug Administration’s Center for Devices and Radiological Health, was started in July 2017 with the intention of easing the regulatory burdens for a select group of medical software developers who would become “pre-certified” and could essentially bypass some regulation procedures. Through the pilot program, the FDA seeks to understand how companies approach the development of health-care technologies so the FDA in turn can figure out what regulation processes are needed to verify an array of emerging technologies from insulin monitoring applications to virtual reality therapy programs. Nine companies, including Apple Inc. and Johnson & Johnson, are already enrolled in the pilot program but the FDA seeks to add more. “The goal of the pre-cert program will be eventually to pre-certify companies beyond the original pilot participants,” Stephanie Caccomo, FDA press officer, told Bloomberg Law in a written statement. Caccomo could not give timing for when more companies would be added and how many would join.

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