FDA Calls For Full Risk Reviews For Device Changes In 510(k) Modifications Draft

05 Aug 2016

• By Sue Darcey

US FDA wants sponsors to complete risk-based assessments and thoroughly consider unintended outcomes of changes they make to already-cleared devices, says a new, highly anticipated draft guidance on 510(k) modifications. This is true whether alterations are made by manufacturers to improve safety or effectiveness, enhance labels, change technology or engineering, or to upgrade materials in a device.

Sponsors of 510(k)-cleared devices would have to conduct very thorough risk assessments of any contemplated changes in safety improvements, labeling, technology or engineering, or materials they use in making products, US FDA clarifies in an Aug. 5 draft guidance on 510(k) modifications. The draft modifications guidance is complemented by a separate draft guidance applicable to software devices, also released on Aug. 5, the agency said.

When the agency reviews comments on this draft and finalizes it, the "modifications" guidance "will provide improved clarity" regarding which...