Trust and transparency in medical device regulationBMJ 2019; 365 doi: https://doi.org/10.1136/bmj.l4166 (Published 18 June 2019) Cite this as: BMJ 2019;365:l4166
- Daniel B Kramer, assistant professor of medicine1,
- Aaron S Kesselheim, professor of medicine2
- 1Richard A and Susan F Smith Center for Outcomes Research in Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA
- 2Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Boston, MA, USA
- Correspondence to: A S Kesselheim email@example.com
In May 2019, the US Food and Drug Administration announced the end of its “alternative summary reporting” programme for collecting adverse event data on medical devices.12 This followed a report from Kaiser Health News describing the programme as an obscure mechanism by which manufacturers of medical devices could meet their statutory requirements to report adverse events but do so outside public view.3 Public outcry around this controversial programme provides an opportunity to review the rationale behind current reporting requirements for adverse events associated with medical devices in the broader context of manufacturers’ responsibilities for post-marketing surveillance.
Each year, the FDA grants marketing authorisation to thousands of new medical devices that have the potential to benefit patients and are classified for regulatory purposes as having a moderate (class II) or high (class III) risk of harm. Manufacturers incur several obligations once they bring a device to market. These include clinical studies, which the FDA can mandate if premarket data are insufficient to identify safety concerns that are uncommon or could …