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FDA Still Seeking Manufacturer Views on Medical Device ISO Regulation

On March 4, 2016, the FDA issued notice in the Federal Register that it had opened a docket to accept comments on the agency’s proposed plan to address the refurbishing, remarketing, rebuilding, remanufacturing, and servicing of medical devices by entities other than the officially listed manufacturer. Although the deadline is drawing near (comments are due by May 3), only 36 comments have been submitted and almost none from manufacturers.  This is surprising, given (1) the number of medical devices on the market that are critical to patient health, (2) the variety of independent servicing organizations (ISOs) and original equipment manufacturers (OEMs), which may or may not have appropriate quality standards or employ technicians with appropriate credentials, and (3) the enormous reporting and quality system responsibilities FDA imposes on manufacturers.  All medical device manufacturers whose products could be serviced by ISOs once on the market should be weighing in on this issue to ensure FDA understands the risks associated with third-party servicing and the potential burdens new regulations could place on manufacturers.

FDA's Suggested Topics of Interest on Third-Party Servicing

Let’s review the questions FDA posed in its request for comments:

  1. Who are the different stakeholders involved with the medical device activities listed previously? What are their respective roles?
  2. What evidence exists regarding actual problems with the safety and/or performance of devices that result from these activities? Specific examples should be submitted.
  3. What are the potential risks (patients/users) and failure modes (devices) introduced as a result of performing the previously defined activities on medical devices? Please speak to issues common to all devices as well as specific risks with specific devices.
  4. These activities are performed by OEMs and various third-party entities, including hospitals and humanitarian organizations. Are the risks different depending on who performs the previously mentioned activities?
  5. We are interested in knowing if these activities are more difficult or riskier to perform on certain devices versus others. Please cite specific examples in your response, along with an explanation of the source of this particular complexity.
  6. What information do third-party entities need in order to perform these activities in a way that results in safe and effective operation of the medical device? Please provide specific examples.
  7. What additional challenges do stakeholders encounter with devices that result from these activities?

Since manufacturers are required to maintain their medical devices according to their proprietary design specifications, manufacturers have a unique perspective on these questions that FDA should hear. For instance, manufacturers have incomparable knowledge of their devices’ failure modes and the information needed to service their devices.  Also, since manufacturers must handle customer complaints, they have direct knowledge of the potential risks introduced by using ISOs or by user facilities employing biotechnicians to service medical devices.

Why Comments from Manufacturers Are Necessary

Speaking from our experience with helping medical device companies deal with FDA compliance issues (especially quality management system compliance), not commenting on FDA’s proposal is risky business for manufacturers for a number of reasons:

  1. Manufacturer control over device returns and servicing provides better control of medical devices, in general. Enhancing the role of ISOs may disrupt oversight of recalls and manufacturers’ ability to regulate and track upgrades to medical device software which typically must take place at manufacturers’ facilities.
  2. Comments submitted by OEMs and ISOs assert that manufacturers should freely provide proprietary device specifications and servicing techniques in order to enable better third-party servicing. Quite simply, this approach would break down protections for manufacturers in favor of secondary market and aftermarket sales.
  3. Many manufacturers contract with ISOs to expand servicing capacity, and FDA’s scrutiny of third-party servicing in general could significantly affect expectations for contracted servicer quality standards.

These are just some of the risks that should be addressed by medical device manufacturers in comments responding to FDA’s notice. Make sure FDA hears your views!  Post comments to the docket by May 3 and plan to attend the public meeting which will be held later this year.

Note that although AdvaMed has requested an additional 30 days to submit comments, FDA has not yet extended the deadline and there is no guarantee that the extension will be granted.

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Benjamin advises pharmaceutical, medical device and biotech companies on the FDA regulatory process to identify the correct regulatory pathway, assisting with FDA communications and strategy.