Note: This post appeared in abbreviated form as the Final Word article in the September/October 2019 issue of BI&T. The history of regulation indicates that it is very difficult to design comprehensive frameworks to deal […]
The ongoing roll out of unique device identifiers (UDIs) promises several expected benefits derived from medical devices possessing UDI codes. The Food and Drug Administration (FDA) recently published Medical Device Safety Action Plan that describes […]
The FDA’s database for medical device recalls has a search function that includes a pull-down menu for the root cause of the recall. These root causes correspond to the single “FDA Determined Cause” on each […]
Last month, the FDA issued its guidance document Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices and a commentary by Bakul Patel. The essence of the form of interoperability addressed is the transfer […]
In April, Rep. Brian Fitzpatrick (R-PA) introduced HR 2163, the Medical Device Guardians Act. This act proposes to add physicians and physician offices to those that must report medical devices misadventures under the FDA’s Medical […]
Two standards in development will, if approved, significantly impact the healthcare technology management (HTM) field. If they aren’t already on your organization’s radar, they should be. The first one involves a push by medical device […]
The FDA Reauthorization Act of 2017 completed its passage through Congress on Aug. 3, and the bill will become law once signed by President Trump. Although a major focus of this legislation is FDA user […]
