WASHINGTON, D.C. – Advamed, the Medtech Association, submitted comments to the Federal Trade Commission in response to a request for public comment on rulemaking regarding “right to repair” policies. AdvaMed and AdvaMed’s Medical Imaging division, in comments, outlined concerns regarding the impact of these policies as they relate to medical devices regulated by FDA.
From the comments: “AdvaMed is deeply concerned that application of “right to repair” policies to FDA regulated medical devices would have significant unintended consequences, presenting new and unnecessary risks to competition, patient and operator safety, device performance, and cybersecurity.
“Safe and effective servicing is not merely acquisition of certain documentation or materials—it is the implementation of and adherence to a set of policies, practices, and procedures which consistently return the device to a state of safe and effective operation. We want our devices to always perform safely and effectively for patient care. Application of “right to repair policies” to FDA regulated medical devices would, unfortunately, work counter to this objective.”
AdvaMed went on to write: “We do not believe there is any legal basis for the FTC to promulgate a rule regarding repairs of medical devices. Any such rule is likely to do far more harm than good. Thus, AdvaMed recommends that the FTC deny the petition to the extent it proposes a right to repair rule that includes medical devices.”
