Medical Devices Under Greater Food & Drug Administration Scrutiny

Medical Devices Under Greater Food & Drug Administration Scrutiny

Between 2009 and 2018, the U.S. Congress and the U.S. Food and Drug Administration (FDA) enacted a number of laws designed to improve the efficiency and effectiveness of premarket medical device reviews. These efforts were intended to restore balance in a regulatory review process that many felt had become too restrictive, depriving U.S. patients of access to the latest medical technology and stifling medical device innovation in the U.S.  

In the past two years, however, there have been several highly publicized events that have thrown into question the ability of regulators in the U.S. and abroad to ensure the safety and effectiveness of medical devices. Journalists wrote investigative pieces about the health risks associated with some medical devices, driving renewed public interest in the regulatory process. In the United States, the FDA responded by publishing a number of policy proposals and plans to address medical device safety without sacrificing the improvements it had made in premarket review processes.

In April 2018, the FDA announced a Medical Device Safety Action Plan, outlining several initiatives to enhance and modernize its regulatory oversight of medical devices in several areas. These initiatives include:

  •      Establishing a robust medical device patient safety net.
  •      Exploring regulatory options to streamline and modernize the timely implementation of post-market mitigations.
  •      Spurring innovation toward safer medical devices.

In November 2018, the FDA published updated information on the plan, describing an ambitious new goal of “ensuring that the FDA is consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices.” Throughout the year, the FDA took steps to evaluate safety concerns raised regarding devices, many of which were focused on women’s health (for example, permanent birth control implants, breast implants and gynecologic surgical mesh).

Throughout 2019, the FDA has continued its focus on medical device safety initiatives, some of which are described below.

Proposed Changes to 510(k) Program

The FDA has proposed significant changes to the 510(k) program, the most common regulatory pathway by which device manufacturers obtain FDA marketing clearance. The process requires companies to show “substantial equivalence” between new devices entering the market and existing products, called predicate devices. The FDA has announced a proposal to publish a list of 510(k)-cleared devices that rely on predicates that are more than 10 years old in order to encourage device manufacturers to rely on more modern predicates. This proposal has been controversial because of its “naming and shaming” approach, and because it does not capture the differences in the need for innovation among various device types.

Safety & Performance-Based Pathway

In January 2019, the FDA established an alternative to the traditional 510(k) approach called the Safety and Performance-Based Pathway. Under this new pathway, devices considered a “well-understood device type” can demonstrate substantial equivalence to a predicate through objective performance criteria rather than direct comparison testing. The performance criteria and associated testing methods for a given device type will be derived from FDA-recognized consensus standards and relevant FDA guidance, and presumably will reflect the characteristics of modern currently-marketed devices. Although the January 2019 final guidance on this program establishes a structure for this program, making the program operational and effective will require further steps, such as establishing the appropriate consensus standards, guidelines and other applicable regulatory controls for particular device types.

Safer Technologies Program (STeP)

The FDA also plans to establish a Safer Technologies Program (STeP), an alternative to the agency’s Breakthrough Devices Program. The Breakthrough Devices Program provides an expedited pathway for the review of medical devices that address an unmet need, and treat or diagnose a life-threatening or irreversibly debilitating disease or conditions. In contrast, STeP would provide a pathway for medical devices that do not meet the criteria of the Breakthrough Devices Program, but offer significant safety improvements, such as innovations that reduce the occurrence of a serious adverse event, address a known device failure or provide safety advantages for users.

Improvements to Post-Market Controls

Efforts to improve the FDA’s ability to use modern information technology to identify safety signals involving devices already on the market have also been announced. The FDA has emphasized its participation in the National Evaluation System for Health Technology (NEST), a national system under development to capture real-world evidence, and help evaluate the risks and benefits of medical devices. The FDA has also announced it will be terminating the alternative summary reporting program under which manufacturers of certain medical devices have been able to report adverse events associated with their products to the FDA on a grouped basis, rather than individually.

As this short review shows, FDA scrutiny of medical device safety has intensified over the last year. Any company that manufactures finished devices, device components, or other supplies or materials used in manufacturing and distributing medical devices should keep a careful eye on these emerging regulatory changes, which can have important effects on quality and safety requirements, as well as the market for particular devices and device types.

Medical Device Manufacturer & Supplier Best Practices

  • Monitoring the medical device environment: Product recalls or adverse events can change the medical device landscape, and FDA press releases on device safety can also have an impact on the market. Monitoring the FDA’s website, as well as relevant trade press media and reports, can lead to more proactive decision-making.
  • Following FDA guidance: The FDA publishes guidance on a variety of substances and parts used to manufacture devices. Businesses that stay on top of FDA guidance will be more likely to avoid legal and business challenges associated with regulatory non-compliance.
  • Reviewing and maintaining compliance with quality agreements: Changes in device component design, construction materials and manufacturing processes can have significant effects on medical device quality, safety and performance. Due to this, manufacturers and suppliers should have a shared, written understanding of each party’s quality and regulatory obligations, as well as operating procedures that avoid surprises such as unapproved changes in design, materials or manufacturing processes. With the FDA itself under increased scrutiny, manufacturers and suppliers should expect the agency to have little tolerance for poor device quality.

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Greg Levine is a Partner and Co-Chair of Life Sciences Practice Group at Ropes & Gray LLP. He has extensive experience representing pharmaceutical and medical device companies before state and federal regulators.