The deletion of a single sentence from the FDA’s final guidance on distinguishing medical device recalls from product enhancements eliminated a sore bone of contention between the watchdog agency and the medtech industry.
In February 2013 the FDA proposed to require medical device companies to report any "product enhancement" intended to reduce health risks, even if the move isn’t part of a safety-related recall.
"Reports of corrections and removals under 21 CFR part 806 may be required for corrections and removals regardless of whether the implemented change meets the definition of a medical device recall," according to the draft guidance.
Medtech stakeholders were quick to object, with parties ranging from AdvaMed to Boston Scientific (NYSE:BSX) calling for a clear distinction between safety-related recalls and product modifications.
"This clarification is critical. Without it, companies taking actions to improve device design, performance or labeling run the risk that their efforts will be viewed by the agency as a remedial action, classified as a recall, and reported in the FDA Enforcement Report as if the device was violative. Thus, the manufacturer’s effort to improve their product resulted in the unfair and unfounded public branding of their product as violative," AdvaMed vice president for technology & regulatory affairs Jeffrey Secunda wrote in May 2013.
Tamima Itani, vice president of global regulatory affairs & regulatory compliance at Boston Scientific, added that companies make thousands of changes to devices every year. Requiring them to report each change would be too onerous, Itani wrote that month.
"Across the industry, there are thousands of changes that occur each year that are not made to reduce a risk to health or remedy a violation. Further, thousands of changes are implemented each year that are not undertaken to improve the performance or quality of a device, but rather, to address discontinued components, parts or materials," she wrote. "When any of the above changes are made absent any violations or risk to health, the manufacturer should not be required to evaluate these changes for a determination of enhancement vs. recall. To do so would be overly burdensome, resource intensive, and would introduce significant delays in a manufacturers’ routine operations."
The FDA’s Center for Devices & Radiological Health appeared to listen, today issuing its final guidance on "Distinguishing Medical Device Recalls from Medical Device Enhancements" without the reporting requirement in the title and omitting the offending sentence.
Instead, the agency said, companies making non-safety-related enhancements "must retain all records for a period of 2 years beyond the expected life of the device, even if the manufacturer or importer has ceased to manufacture or import the device. If there is a change in ownership, records required to be maintained must be transferred to the new manufacturer or importer of the device and maintained for the required period of time."
Secunda told MassDevice.com via email today that the trade lobby is still digesting the final guidance.
"AdvaMed is still reviewing all the details of FDA’s final guidance on device recalls and enhancements. However, we are pleased that the agency explicitly states in the guidance that enhancements will not require submission to FDA of 806 (Corrections and Removals) reports," Secunda said.
