Congress Requires FDA to Address Issue of Device Service

Posted August 8, 2017

After passing the Senate 94-1 on Aug. 3, the FDA Reauthorization Act of 2017 is just a signature away from becoming law. The measure is poised to impact the healthcare technology community in two significant ways: through the renewal of the “user fees” imposed on medical device manufacturers and with a call for a report that will dive into the hot issue of medical device service, especially by third parties.

Several key lawmakers issued a joint statement, describing the bill as a victory for patients.

“Working together, House and Senate Republicans and Democrats brought forth a bill to reauthorize these important programs, putting patients first and their hope for new treatments within reach,” said Energy and Commerce Committee Chairman Greg Walden (R-OR), Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ), Health Subcommittee Chairman Michael C. Burgess (R-TX), and Health Subcommittee Ranking Member Gene Green (D-TX). “This bill is a win for patients and the millions of Americans working to develop our next generation of cures and therapies. We applaud the Senate’s swift action in passing this vital bill, and urge President Trump to sign it into law.”

Working against a Sept. 30 deadline, the Senate passed the House version of the bill so the two chambers wouldn't have to work out a final version. This legislation will allow the Food and Drug Administration (FDA) to collect more than $320 million in user fees from medical device manufacturers over the next five years.

It also includes a provision that requires the FDA to produce a report that addresses “the continued quality, safety, and effectiveness of devices … with respect to servicing” within 270 days of being signed into law. The bill defines servicing as “refurbishing, reconditioning, rebuilding, remarketing, repairing, remanufacturing, or other servicing of the device.”

According to section 710 of the FDA Reauthorization Act, the report must include:

  • The status of and findings from the FDA’s March 2016 call for comments regarding the “refurbishing, reconditioning, rebuilding, remarketing, remanufacturing, and servicing of medical devices performed by third-party entities and original equipment manufacturers,” which generated 176 original submissions.
  • Information presented during the October 2016 public workshop of the same title.
  • A description of the statutory and regulatory authority of the FDA with respect to the servicing of devices conducted by any entity.
  • Details regarding how the FDA regulates servicing and how it could improve such regulation using existing or additional authority.
  • Information on actions the FDA could take under its current authority to assess servicing, including the size, scope, location, and composition of third-party entities.
  • Information on actions the FDA could take to track adverse events caused by servicing errors by anyone who performs such service.
  • Information regarding the regulation by states, The Joint Commission, or other regulatory bodies of device servicing.
  • Any additional information determined to be relevant to ensuring the quality, safety, and effectiveness of devices with respect to servicing.

The Medical Imaging & Technology Alliance (MITA) applauded the Senate for passing the Medical Device User Fee Amendments (MDUFA), one aspect of the overall reauthorization act.

“The Senate passage of MDUFA is another critical step towards a victory for patients, the industry and the agency,” said Joe Robinson, chairman of the MITA board of directors and senior vice president of health systems solutions at Philips Healthcare, in a statement. “As the bill moves to the White House for signature, we applaud the bipartisan efforts of the House and Senate to find reasonable, common-sense solutions to clear regulatory hurdles that hinder medical innovation and ensure patient access to life-saving technology.”

In its official statement, MITA also acknowledged that the legislation requires the FDA to produce a report about medical device servicing, writing: “Currently, only medical device service activities performed by a manufacturer are regulated by the FDA. If a device fails to perform in a safe and effective manner due to improper servicing by an unregulated, third-party organization, it could potentially put the patient at risk for serious physical injury or result in low image quality―which could lead to a delayed or missed diagnosis.”

In May, MITA testified before the House Energy and Commerce Committee’s health subcommittee about the need to expand FDA oversight to third-party servicers.

For many healthcare technology management (HTM) professionals, though, the inclusion of section 710 is a solution in search of a problem.

“The discussions last year with the FDA have already provided plenty of proof that there are very few issues that need their attention,” said Binseng Wang, director of quality and regulatory affairs at WRP32 Management, Inc. and Greenwood Marketing LLC. “Everybody can save a lot of money, energy, and resources not to pursue something that does not really exist out there. This is like a wild goose chase.”

Wang, whose statements represent his personal views and not those of his employer or any other organization, called on the HTM field to “either do something now or forever hold your peace!”

Still, others are less concerned by the legislation and have advocated for more of a “wait and see” approach.

“Other than calling for this report and setting a corresponding deadline which the FDA may or may not meet, the FDA Reauthorization Act of 2017 may not result in anything new when it comes to the long-running service debate, but we will have to wait and see,” William Hyman, an adjunct professor of biomedical engineering at The Cooper Union and a consultant in New York, wrote in a post on the AAMIBlog.

It is not clear what the FDA will conclude in its report. During the congressional hearing back in May, Jeffery Shuren, director of the FDA’s Center for Devices and Radiological Health, seemed reluctant to provide a clear position on the thorny question of regulatory oversight of medical device service and instead deferred to the judgement of Congress.

“We are not at the stage where the agency or the administration has made a determination one way or the other on whether―or what―action should be taken, but if Congress has a perspective on what we should be doing, that would be very helpful,” he said.