The Medical Imaging and Technology Alliance (MITA) has published a white paper about third-party medical device servicing businesses and is now asking for more regulatory oversight of these firms by the U.S. Food and Drug Administration (FDA).
The white paper, entitled "Understanding Accountability in Medical Device Servicing," outlines the types of organizations that conduct medical device servicing and how they are held accountable. Since no authority holds third-party servicing businesses accountable for their actions or the quality and safety of their work, MITA is calling for the FDA to provide oversight.
MITA believes third-party service businesses should be held to certain minimum requirements, including the adoption of a quality management system conformant with 21 CFR 820, which would have them registering with the FDA.
