FDA Medical Device Regulation

Innovation under regulatory uncertainty: Evidence from medical technology

“…Combined with limited clarity about the scope of the FDA’s regulatory authority over medical devices, this meant that the FDA’s oversight of devices occurred primarily on an ad hoc basis following this ruling. It wasn’t until 1976, after a series of well-publicized medical device failures, that Congress passed the Medical Device Amendments Act (MDA) to the FDCA, which gave the FDA primary authority to regulate devices sold in the United States (Sall, 2008; Kramer et. al., 2012; Munsey 1995).…”

“…Devices can be used, implanted, or otherwise administered in hundreds of ways. Furthermore, how a device is used or the method by which an implantable device is placed in the human body is often not only unique, but also critical to the success or failure of a trial (Sall, 2008). In summary, the large degree of heterogeneity across medical devices and in the processes required for their evaluation, combined with limited information about how clinical trials should proceed and be presented to regulators, results in a much greater degree of uncertainty about the content and format requirements for new device approvals (vs. new drug approvals).…”