21st Century Cures Draft Bill Establishes Innovation Pathway

The House Energy and Commerce Committee has released a new, shorter draft of its 21st Century Cures legislation, setting in motion an expedited pathway to speed access to breakthrough medical technologies.

Under the proposed legislation, devicemakers developing advanced technologies that either have no alternative or offer a significant improvement over existing alternatives could apply for a priority review designation before submitting an application.

The legislation describes breakthrough technologies as offering significant advantages over existing approved or cleared alternatives, including the potential to reduce or eliminate the need for hospitalization, improve patient quality of life, facilitate patients’ ability to manage their own care or establish long-term clinical efficiencies.

A team leader at the FDA would shepherd the product through a streamlined review process, including interactive communication and early agreement on clinical trial design. The draft calls for senior agency personnel to oversee these products and ensure a smooth development and review process.

HDE Criteria Expanded

The draft bill would also increase the use of humanitarian device exemptions by changing the definition of a rare disease from one with fewer than 4,000 diagnosed cases to one with not more than 8,000.

The bill would also allow devicemakers to rely more on observational studies, patient registries and real-life therapeutic use to demonstrate safety and effectiveness. The emphasis would be on reducing regulatory duplication and unnecessary delays and incorporating local considerations, community values and mechanisms to protect vulnerable populations into trial design.

The draft bill also calls for new guidance on the least-burdensome provision, which limits the amount of information the agency can request from devicemakers, and on the use of recognized standards in the device approval process.

Certain types of medical software would be exempted from FDA regulation under the bill, including programs used in administrative, clinical or laboratory recordkeeping; programs that simply store, retrieve and transmit data; and apps to help people maintain a healthy lifestyle, such as fitness trackers. The FDA previously said it has no plans to regulate most of these products.

The Senate is developing a similar version of the bill, but it isn’t publicly available.

Read the House draft here: www.fdanews.com/04-15-21stCenturyCures.pdf.
— Jonathon Shacat and Elizabeth Orr