查看文章

To the Editor—The US Congress authorized the Food and Drug Administration (FDA) Breakthrough Devices Program (BDP) in December 2016 in an effort to expedite patient access to innovative devices indicated for the diagnosis and treatment of serious illnesses1. In August 2019, the US Centers for Medicare and Medicaid Services (CMS) subsequently finalized changes increasing hospital reimbursement for breakthrough devices to promote clinical adoption2. Since program inception, the BDP has grown at a rapid and increasing pace: as of 1 January 2020, the FDA had granted breakthrough designation to 222 devices, representing nearly 200% program growth over the past year. To shorten device development and review times, the FDA has approved breakthrough devices on the basis of less rigorous premarket evidence with the intention of collecting complementary postmarket data. For example, the FDA …