Manufacturers anticipate key guidance on medical device safety in 2020

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Alexander Gaffney Senior Manager, Health Research Institute, PwC US October 18, 2019

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The FDA expects to release guidance next year on two critical device safety programs: the Safer Technologies Program and the Safety and Performance Based Pathway, according to a guidance agenda for 2020 released last week by the agency’s Center for Devices and Radiological Health (CDRH).

The agency has been transforming its device safety processes in recent years, and the expected guidance likely will shed more light on the details of those efforts. The Safer Technologies Program allows for the expedited review of device improvements meant to improve the safety of medical devices. The Safety and Performance Based Pathway is intended to expedite the review of products that conform to FDA-established standards for well-understood devices.

The list of documents also includes the development of a third-party review program for low-risk medical devices, new standards for medical device cybersecurity, and the creation of a review pathway for medical software with multiple functions.

Other guidance documents speak to safety concerns known to regulators, including surgical staplers associated with malfunctions and fatalities, as well as certain types of breast implants associated with elevated risks of cancer.

HRI impact analysis

The FDA has been making significant changes to its medical device regulatory programs, simultaneously trying to improve the safety of certain products and to expedite their review, clearance or approval.

The FDA regulates medical devices according to their relative safety risks to patients, as defined by the agency. Novelty also plays a role, and the agency submits new devices to greater scrutiny.

While many of the coming changes will help to expedite product approvals, not all may be beneficial to the industry. For example, a recent change will limit the use of older predicate devices now used as reference products to support the clearance of medical devices.

Instead, those predicate devices will have to have been approved within the past decade. Pending changes to how the FDA regulates medical device cybersecurity could also require companies to develop new cyber competencies, which will benefit patients but could be challenging for device manufacturers with large portfolios of devices to comply with.

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Trine K. Tsouderos

HRI Regulatory Center Leader, PwC US

Tel: +1 (312) 241 3824

Alexander Gaffney

Senior Manager, Health Research Institute, PwC US

Tel: +1 (202) 836 1604

Crystal Yednak

Senior Manager, Health Research Institute, PwC US

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