The Medical Imaging & Technology Alliance (MITA) has continued its push to get the FDA to clarify the difference between servicing and remanufacturing.
MITA released a revised version of its Considerations for Remanufacturing of Medical Imaging Devices white paper, which was originally issued in February, on Sept. 26. This latest edition includes detailed descriptions of what the group says constitutes both activities. It also offers steps manufacturers can take to make sure that servicing and remanufacturing are documented and performed properly.
“By updating this white paper, we hope to create a resource for involved parties to ensure that third-party device servicing activities are done in a manner that protects patient health and safety and are clearly distinguished from remanufacturing,” Dennis Durmis, head of the MITA board and Bayer Healthcare’s chief of the Americas region, said in prepared statement.
Currently, the FDA does not regulate third-party medical device servicers, with no mandated controls to say whether servicing activities may constitute remanufacturing, MITA noted. With few safeguards in place to regulate remanufacturing, the alliance is concerned this could pose risk to the safety of device users.
Last year, the FDA sent a report to Congress expressing its intent to develop a guidance on remanufacturing. The administration was accepting public comment up until February this year on its own public workshop and white paper related to the topic.