FDA May Seek New Authority Under Device Safety Action Plan

April 20, 2018

The FDA released a new action plan aimed at assuring the safety and effectiveness of medical devices while addressing unmet patient needs.

FDA Commissioner Scott Gottlieb said the Medical Device Safety Action Plan will use existing tools in new ways and also identify areas where the agency may need to seek additional authority.

Last year the FDA approved a record number of devices, leading to both greater benefits and greater risks to patients, Gottlieb said.

One proposed element in the five-prong plan would integrate CDRH’s premarket and postmarket offices to use a total product life cycle (TPLC) approach.

The center has historically been organized according to the stages of a product’s life cycle, allowing staff to become specialized by function, but not always promoting the communication and collaboration that is necessary for continuously evolving innovation of medical devices, the agency said.

CDRH is evaluating a potential restructuring of one large office into seven smaller device-specific offices that would each be responsible for premarket review, postmarket surveillance, manufacturing and device quality, and enforcement. The new structure would include a separate office dedicated to clinical evidence and analysis.

Gottlieb said that the reorganization of CDRH’s premarket and postmarket offices into a TPLC structure would allow experts to share both pre- and postmarket information,, improving decision making and allowing timely implementation of corrections discovered as postmarket data from real world clinical settings is collected and analyzed.

The agency also plans to establish a “robust medical device patient safety net” using the National Evaluation System for health Technology (NEST) to link data from different electronic health information sources, including device registries, electronic health records, medical billing claims and patient-generated data.

The plan also establishes the Women’s Health Technologies Strategically Coordinated Registry Network (CRN) to address data gaps in the field of women’s health, improving the quality and efficiency of real world evidence collection in clinical areas that are unique to women.

In another plan element, the agency will consider regulatory options to streamline and modernize “timely implementation of postmarket mitigations,” exploring whether the agency has the authority to issue “umbrella regulations” to identify devices that may require additional training or user education beyond the physician labeling that is currently required.

In his statement about the plan, Gottlieb said the FDA may also “consider invoking restricted device authority” on a case-by-case basis to increase patient protection for the highest risk devices. This would allow the agency to impose requirements on specific high-risk devices while still allowing access to the devices to those patients who could benefit from such access.

Another prong of the plan would spur innovation towards safer medical devices by providing regulatory incentives and scientific expertise that help drive greater competition. The agency is considering developing a program similar to the Breakthrough Device Program, which gives patients who need it access to innovative new devices. The new program would support the development of safer devices that do not meet Breakthrough Program criteria but are intended to be safer than current technologies on the market.

“Safety and innovation should go hand in hand,” said Gottlieb, noting that the plan will encourage manufacturers to make even modest changes to their devices when such adaptions lead to a reduction in risk for patients.

A separate plan element would improve device cybersecurity by seeking additional authority to require firms to build the capability to update and patch device security into a product’s initial design. The FDA also intends to develop a CyberMed Safety (Expert) Analysis Board as a public-private partnership to complement existing cyber coordination and response mechanisms.

Read the full action plan here: www.fdanews.com/04-19-18-MDSafetyActionPlan.pdf. — Donna Scaramastra Gorman