The Food and Drug Administration said in a letter on Wedensday that some labelers of single-use implants will have until Sept. 24, 2016 to comply with the FDA’s UDI marking requirements. The extra time will allow for implant sterilization before use to comply with the FDA’s rules. The FDA originally required markings on the devices, but safety concerns led to changing requrieemnts so the markings could be on product packaging. Single-use devices are sometimes sterilized apart from the implantation process, according to the report, which means packaging is discarded.
AdvaMed successfully advocated on behalf of the device companies to delay requirement deadlines so companies can implement markings appropritley.
More articles on spine devices:
Investor notes: 6 spine device company updates
Yale student scoliosis brace tracking device startup gets $100k
How will Medtronic pay for Covidien?
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.
