FDA Schedules Workshop on Medical Device Servicing and Remanufacturing

The FDA will hold a public workshop in December on medical device servicing and remanufacturing activities as it develops a planned draft guidance on the topic.

The Dec. 10 workshop in Gaithersburg, Maryland will discuss the distinction between servicing and remanufacturing and will consider opportunities for collaboration among medical device servicing and remanufacturing stakeholders, the agency said.

The agency issued a report in May that concluded there is insufficient evidence of a widespread public health concern related to servicing of medical devices that would justify imposing new regulatory requirements.

The planned draft guidance on servicing and remanufacturing is on CDRH’s priority list for fiscal year 2019.