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labeling, technology or engineering, or materials they use in making products, US FDA clarifies in an Aug. 5 draft guidance on 510(k) modifications. The draft modifications guidance is complemented by a separate draft guidance applicable to software devices, also released on Aug. 5, the agency said.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...