The “Right to Repair” issue pertains to FDA-regulated medical devices and the unintended negative consequences for patient health and safety that would result if unregulated third-parties were allowed to work on these highly sophisticated pieces of equipment.
“Right to repair” advocates point to FDA’s 2018 report they claim led the agency to “take a pass” on regulating third party device servicing because they could find no evidence of a problem. Cheery-picked quotes describe third-party servicers as providing “high quality, safe, and effective servicing of medical devices … critical to the functioning of the U.S. healthcare system.”
This is out of context, wrong and dangerous. The fact of the matter is that the FDA report said the agency didn’t have enough data to make a definitive conclusion about third party servicing. The FDA doesn’t have that data because unregulated servicers aren’t required to register with the agency and FDA can’t even establish how many third-party servicers are actually out there – though the agency estimates there are between 16,000 - 21,000.
Further, the FDA’s 2018 report showed the majority of inadequate services reported should actually be categorized as remanufacturing, meaning that the device in question is no longer the device the FDA gave clearance/approval to. Big difference. Big problem.
In truth, the agency laid out a roadmap to address this issue and has been executing against it over the last several years through remanufacturing guidance and cybersecurity discussion papers. This is where the FDA should concentrate its efforts: educate, surveil and enforce actions on remanufacturing to ensure service activity doesn’t cross over into regulated activity.
On July 27, the FDA is holding a public meeting on this topic. It couldn’t come at a better time. The proper servicing and security of medical devices and other health care technologies mustn’t be allowed to be undermined by third-party servicing apologists willing to employ bad faith tactics and misrepresent the facts.
“Right to repair” advocates point to FDA’s 2018 report they claim led the agency to “take a pass” on regulating third party device servicing because they could find no evidence of a problem. Cheery-picked quotes describe third-party servicers as providing “high quality, safe, and effective servicing of medical devices … critical to the functioning of the U.S. healthcare system.”
This is out of context, wrong and dangerous. The fact of the matter is that the FDA report said the agency didn’t have enough data to make a definitive conclusion about third party servicing. The FDA doesn’t have that data because unregulated servicers aren’t required to register with the agency and FDA can’t even establish how many third-party servicers are actually out there – though the agency estimates there are between 16,000 - 21,000.
Further, the FDA’s 2018 report showed the majority of inadequate services reported should actually be categorized as remanufacturing, meaning that the device in question is no longer the device the FDA gave clearance/approval to. Big difference. Big problem.
In truth, the agency laid out a roadmap to address this issue and has been executing against it over the last several years through remanufacturing guidance and cybersecurity discussion papers. This is where the FDA should concentrate its efforts: educate, surveil and enforce actions on remanufacturing to ensure service activity doesn’t cross over into regulated activity.
On July 27, the FDA is holding a public meeting on this topic. It couldn’t come at a better time. The proper servicing and security of medical devices and other health care technologies mustn’t be allowed to be undermined by third-party servicing apologists willing to employ bad faith tactics and misrepresent the facts.
