Industry Offers Mixed Response to FDA’s Safety Action Plan

Industry stakeholders lauded the FDA’s efforts to make greater use of real-world data and to take a total product lifecycle approach to regulation as outlined in its proposed Medical Device Safety Action Plan.

However, AdvaMed and Johnson & Johnson took issue with the agency’s plan to identify areas where it might seek additional authority

The FDA said it would consider regulatory options to streamline and modernize “timely implementation of postmarket mitigations,” exploring whether it has the authority to issue “umbrella regulations” to identify devices that may require additional training or user education beyond the physician labeling currently required.

AdvaMed said in its comments that it had concerns with the FDA proposal to impose special controls through an umbrella regulation. It questioned the merit of such a move and said that currently the FDA lacks the authority to do this. If the agency were to move toward this, it would need to seek further input from stakeholders; as such a move would have “far-reaching and unexpected effects.”

The FDA’s safety action plan would also “consider invoking restricted device authority” on a case-by-case basis to increase patient protection for the highest risk devices. The association suggested that the FDA should instead look at its internal processes to identify “whatever internal obstacles prevent efficient practice.”

Total Product Life Cycle

AdvaMed praised the FDA’s plan for CDRH to shift to a total product life cycle organizational structure. 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.

Reorganization of CDRH’s premarket and postmarket offices into a total product life cycle 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 said.

AdvaMed also supported the agency’s use of real-world evidence to better understand how products are used and experienced in the real world. “AdvaMed continues to support FDA’s efforts to use RWE in its regulatory decision making” and its collaboration with the National Evaluation System for Health Technology Coordinating Center (NESTcc), the association said.

Innovation

Another prong of the safety action plan would spur innovation towards safer medical devices by providing regulatory incentives and scientific expertise that help drive competition (IDDM, April 23).

AdvaMed disagreed with language in the action plan that suggested that a voluntary 510(k) pathway for certain moderate-risk devices would send a signal that the pathway would be safer compared to demonstrated substantial equivalence to a predicate device.

Johnson & Johnson said it supports a more modern 510(k) pathway, but it took issue with a statement in the action plan that said the marketplace “does not provide strong incentives to make an established device safer in the absence of a new or greater-than-previously-understood safety concern.”

The devicemaker stressed that its chief medical officers are involved in all aspects of device development, and its first-in-human development committees review all accumulated safety data before allowing teams to introduce certain new devices.

J&J said its teams incorporate real-world evidence into proactive safety monitoring and noted that J&J was the first company to share clinical trial data from across its portfolio of products with researchers around the world.