Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Medical Device and Diagnostic Industry (MD+DI), in “Will Remote Software Updates Become the Norm for Medical Devices?” by Heather R. Johnson.
Following is an excerpt:
Overcoming compatibility issues, obtaining FDA clearance, and ensuring security are just a few reasons why some medtech companies hesitate to prioritize interconnectivity, said Bradley Merrill Thompson, a member of the law firm Epstein Becker & Green, PC. Thompson counsels medical device, drug, and combination product companies on FDA regulatory, reimbursement, and clinical trial issues. “They often have firmware that they leave on the device for a long time because the hassle and cost of going through regulatory hoops is so considerable,” he says. …
Thompson added that if a software update fixes a bug or technical issue, the manufacturer may have to file an adverse event report under FDA’s Medical Device Reporting (MDR) measures. Under 21 CFR 806, medical device manufacturers must report actions concerning device corrections and removals to FDA. “If you update a medical device to address a safety or effectiveness issue, you may have to report that to the FDA,” said Thompson.