The FDA and the GAO both released data on the FDA’s performance in medical device regulation over the last several years. This article takes a close look at this data and compares it with the data available through the FDA’s OpenFDA database. The data shows recalls have increased, but postmarket and postapproval studies have declined.
The pharmaceutical industry’s frustration with the pace of medical device approvals has been well-known over the years. Top executives routinely express frustration with the lack of speed of the regulatory process. According to a PwC survey published in early 2015, industry leaders indicated that they were open to regulatory reforms, including stricter post-market safety requirements and restrictions on promotional activities, to speed access to new treatments.37 Specifically, 71% of responders were willing to accept stricter post-market surveillance in exchange for more accelerated and predictable approval programs. The Government Accountability Office and the Food and Drug Administration issued reports on the FDA’s performance in the medical device arena late 2015. So how is the Food and Drug Administration (FDA) doing concerning medical devices? By combining a review of the Government Accountability Office (GAO) study with the FDA’s data, we find the picture to be mixed.
Read Full Article in the June 2016 Issue of Life Science Compliance Update