The federal Food and Drug Administration is becoming stricter about its process for approving medical devices, according to a consultant for regulatory affairs. Those changes are coming about in response to scrutiny and criticism over a process that allows devices to be approved based on their similarity to devices already on the market.
A recent article in the Electronic Engineering Times quotes consultant Chris Henza, who spoke at the DesignMed professional conference in California.
Henza said the 510(k) process, which employs the standard of “substantial equivalence” to previously approved devices, is used to approve about 4,000 “moderate risk” products each year.
New, tighter parameters suggest the FDA will consider only one main and one secondary predicate device, Henza said. In the recent past, applicants frequently pointed to as many as 30 of those previously approved devices.
The added scrutiny is due in large part to two particular devices approved under the 501(k) loophole.
Vaginal mesh implants, used to treat urinary incontinence and pelvic organ prolapse, have prompted thousands of reports of malfunction, injury and death. Among the reported complications are crippling pain, infection, bleeding and organ perforation.
All-metal hip implants by DePuy Orthopaedics, also approved under the 501(k) process, were recalled because of high early failure rates, in addition to metal debris breaking off and getting into patients’ soft tissues.
If you’ve suffered injury as a result of a transvaginal mesh implant or a DePuy Orthopaedics hip implant, contact Lopez McHugh for a free consultation.
See the article here: https://www.embedded.com/electronics-news/4370059/FDA-s-510-k–gets-tougher–more-predictable