Dive Brief:

• FDA identified new regulatory priorities for medical devices in its fiscal 2020 budget justification document, including proposals to safeguard against shortages of essential devices and to compel manufacturers to address cybersecurity. The document offers more detail on the administration's budget proposal released last week.
• The agency also floated establishing alternative pathways to the premarket notification 510(k) process for certain devices in the nearly 400-page Justification of Estimates for Appropriations Committees report.
• Another proposal would change the process for imposing special controls to allow use of an administrative order rather than regulation.

Dive Insight:

The report follows President Donald Trump’s fiscal 2020 budget proposal that supports a number of medtech priorities on FDA’s wishlist. FDA is requesting a total budget of $6.1 billion, a 12% increase over fiscal 2019.

Initiatives identified by FDA most urgently in need of investment in 2020 include efforts to reduce harm from opioid addiction and youth tobacco use; support production of quality compounded drugs; encourage medical product innovation; improve the safety of food, medical devices and the blood supply; and develop responses to chemical, biological and other threats as well as infectious diseases.

In the area of medical devices, FDA has proposed efforts to address priorities that include:

Device shortages. FDA is seeking authority to make companies notify the agency if a significant interruption in the supply of an essential device is expected. The plan would require companies making devices deemed essential to provide FDA with information on manufacturing capacity and authorize the temporary importation of devices when risks to public health outweigh compliance with U.S. regulatory standards. Circumstances may include interruption of manufacturing due to scarcity of a raw material or unavailability of a component.

Cybersecurity. FDA wants to require that devices are capable of being updated and patched in a timely manner. Agency officials would like premarket submissions to include evidence of this capability and thinks device makers should publicly disclose when they learn of a cybersecurity vulnerability. The proposal also seeks to improve proactive responses to cybersecurity vulnerabilities.

Premarket notification determinations. FDA would establish a voluntary alternative to the premarket notification 510(k) pathway that would allow manufacturers of certain well-understood device types to use pre-specified safety and performance criteria to demonstrate substantial equivalence. The proposal would permit the marketing of certain Class II and Class I devices requiring premarket notification if the products can show conformance with the safety and performance criteria.

Progressive approval. FDA would permit expedited access to devices that would otherwise be reviewed under the premarket approval or De Novo pathways if they are intended to treat or diagnose a life-threatening or irreversibly debilitating condition and address an unmet medical need. The devices would be eligible for provisional approval based on demonstration of safety and performance plus additional risk mitigations. Companies would be required to gather postmarket data to assure timely evidence generation. Permitting an initial provisional approval would encourage manufacturers to seek earlier introduction of their devices in the United States, offering patients earlier access to important medical technology.

Special controls. FDA would change the process to impose, revise or eliminate special controls for class II devices by using an administrative order rather than regulation. Implementing mitigations such as labeling, user training or device features through the imposition of additional special controls currently requires rulemaking. The proposal aims to create a faster process to mitigate risk and address safety signals in the postmarket setting, the agency said.