EMERGO SUMMARY OF KEY POINTS:

• New legislation significantly impacting FDA oversight of US medical device and drug markets has become law.
• The 21^st Century Cures Act establishes a priority review program for breakthrough devices, loosens some device clinical trial requirements and clarifies how and whether to regulate medical software.
• Critics of the new bill warn that efforts to streamline FDA regulations may end up allowing some devices into the US market without proper vetting, causing public health issues.

Effects of the recently enacted 21st Century Cures Act on registration and oversight of medical devices in the US will be significant.

The 21^st Century Cures Act, which has garnered rare bipartisan support in Congress and is heavily backed by pharmaceutical and medical device industry lobbyists, is set to fast-track “breakthrough” and novel device registrations at the FDA, as well as alter clinical investigation requirements of manufacturers. Critics of the proposed legislation, however, warn of public health repercussions if FDA regulations of medical devices are made too lax.

Prioritizing “breakthrough” devices

Among the substantial changes to FDA medical device regulation included in the 21^st Century Cures Act is a proposal to require the agency to set up a priority review program for “breakthrough” devices, or for devices targeting diseases for which no FDA-cleared or approved alternatives are available. The program builds upon a framework already in place at the agency for registration of such devices.

Under the program, a manufacturer or sponsor may request priority review designation before submitting its FDA registration application. The bill authorizes the Secretary of the US Department of Health and Human Services to develop and issue additional guidelines specifying parameters and requirements of the program.

Regulatory process improvements

The Act also includes a number of what it refers to as improvements to the FDA’s medical device oversight processes:

• The Act requires the FDA to train staff involved in reviewing premarket applications according to “least burdensome” concepts. This requirement entails updating FDA guidance issued in 2002 pertaining to the FDA Modernization Act of 1997’s Least Burdensome provision.
• Regulatory requirements for reasonable assurance of safety and effectiveness are eased for some Class I and Class II medical devices under the Act.
• “Innovation projects” provide $500 million over 10 years to the FDA to speed up patient access to medical devices and drugs “while maintaining the same standard for safety and effectiveness.”
• FDA authority to apply humanitarian device exemptions is expanded; the agencymay apply such exemptions to devices that treat diseases affecting up to 8,000 people, whereas currently the exemption is capped at 4,000 people.
• Stronger processes are established to ensure proper expertise among device classification review panel members; device manufacturers and sponsors are allowed to make their cases before classification panels.

Device clinical trial changes

Various aspects of medical device clinical trial requirements will also change under the Act.

For example, rules for Institutional Review Boards (IRBs) responsible for assessing clinical trials would change; currently, a clinical trial sponsor must utilize an IRB located in the same area as where the trial is being conducted. The Act allows sponsors to enlist centralized models rather than local entities to meet IRB requirements.

Trial sponsors may request posting of trial data on the ClinicalTrials.gov website prior to final clearance or approval of their devices.

In addition, the Act requires the FDA to update and clarify its stance on when to issue waivers to Clinical Laboratory Improvement Amendments (CLIA) in order to boost patient access to point-of-care diagnostic products.

Medical software clarifications

One of the trickier topics the FDA has had to tackle in recent years—whether and how to regulate medical software that may or may not qualify as a medical device—is also addressed by the Act.

The Act identifies five major types of software:

• Software for administrative support of healthcare facilities
• “Healthy lifestyle” software that provides no diagnostic, prevention or treatment function
• Electronic patient records
• Software for transferring, storing or displaying medical device or clinical laboratory test data but that does not support interpretation or analyze clinical data
• Software to acquire, process or analyze medical images from an IVD or signal acquisition system

The new law views these types of software as posing little to no risk to patients, and thus does not consider FDA regulation of such products necessary provided they meet certain safety conditions. However, if a safety concern related to such software does arise, the Act provides the FDA with the authority to regulate the product in question.

What’s next?

Now that noth Congress and President Barack Obama have approved the 21^st Century Cures Act, US medical device market registrants should begin mapping out how the new law’s major changes to how the FDA regulates their products. Emergo will report on the various moving parts of the Act as they are implemented in the coming months.