A research letter published in JAMA Internal Medicine this week finds that class III medical devices that receive expedited reviews are more likely to be recalled, and after spending less time on the ...

The U.S. Food and Drug Administration (FDA) categorizes medical devices into three classes based on the level of risk the devices pose to patients and users. Image Credit: IGORdeyka/Shutterstock.com ...

When I was writing last month’s column about former CDRH engineer Leroy Hamilton’s down-the-rabbit-hole quest for a better Form FDA-3429 for guiding device classifications at CDRH, I had no way of ...