The Truth About FDA-Regulated OEM Servicing
G. Wayne Moore
07/13/2021
Since the beginning of the FDA 3rd Party Service docket – more than 5 years ago – there has been an abundance of misinformation introduced by some stake-holders regarding questions like: Who is a 3rd Party? Does it include hospital employed HTMs? Do hospitals and 3rd party servicers have a “right” to repair their own MRI? The latest misinformation recently published in LinkedIn in response to a published article entitled “How Right to Repair Thwarts Free Enterprise,” made the astonishingly ignorant statement that “OEMs are self-regulated in their service programs…I am not aware of any of the OEM’s whose service divisions are actually ISO certified, rather they fall under ISO “Compliant” whereas many independent service organizations are actually certified in either ISO 9001 or 13485 with true audits unlike the OEM’s who have internal audit for their service organizations.” On the contrary, Medical Device Manufacturers fall under the FDA Quality System Regulation “Good Manufacturing Practices (GMP) – 21 CFR Part 820, which includes service. As it says in the FDA training slide below, “(OEM) Manufacturing facilities undergo FDA inspections to assure compliance with QS requirements.” So, the claim made above that OEMs are “self-regulated” when it comes to servicing their products is both ignorant and, perhaps, intentionally misleading.
Having been responsible for both FDA inspections and ISO audits, I can assure the reader that the FDA inspection is an order of magnitude more comprehensive than an ISO audit. There is simply too much misinformation and ad hominid hyperbole going on concerning the OEMs to take many of these R2R advocates seriously. They are hurting their own cause with this non-sense.
If there is any subject you would like me to weigh-in on in future articles please email me – [email protected], I would enjoy hearing from you.
Until Next Month,
Wayne