The 21st Century Cures Act (the Cures Act) includes many significant changes to the regulatory landscape for medical devices. Signed into law by former President Barack Obama on December 13, 2016, with overwhelming support in the House (392-26) and Senate (94-to-5), the law has important implications for clinical trials and the means of bringing a device to market. While some provisions come on line sooner than others, what is certain is device developers should begin to factor these changes into their clinical development and regulatory planning.
Curious about which items will have the greatest impact on the medical device industry? Here’s your executive summary:
Breakthrough device pathway enhanced and expanded
The Cures Act establishes criteria for products considered to be “breakthrough devices” and strengthens the Expedited Access Pathway program. Devices that make the cut have a streamlined review process, and sponsors will benefit from direct, prioritized communication with the FDA throughout.
While the FDA’s existing Expedited Access Pathway program was limited to premarket approval applications (PMAs) and de novo requests, the new Breakthrough Device program will extend priority review to 510(k) applications.
What qualifies as a breakthrough device? Classification here is fairly broad. The device must treat or diagnose life-threatening or irreversibly debilitating diseases or conditions, and must also represent a technological breakthrough, have no approved or cleared alternatives (or significantly improve upon them), or in some other way demonstrate itself to be in the best interest of patients.
The HDE Program boosts eligibility
Humanitarian Device Exemption (HDE) is a market pathway that helps develop medical devices for rare diseases and conditions in which there is no approved comparable device. A Humanitarian Use Device (HUD) designation previously only applied to devices for conditions affecting fewer than 4,000 individuals per year in the US, but the Cures Act doubles the cap to 8,000. This change should result in broader use of this less evidence-intensive pathway where ‘probable benefit’ is the standard by incentivizing device manufacturers and increasing the numbers of products that qualify for HUD status.
FDA will stay up to date on independent standards, speedier evaluations
US and international standards organizations, such as ISO, can move fast, but prior to the Cures Act, the FDA was not bound by law to recognize these standards quickly or explain their decisions. Now, the FDA must decide whether or not to recognize a standard within 60 days of receiving a request to do so, and publicly state the reasons for a “yes” or “no” verdict.
Sponsors will get more say on classification panels
The Cures Act stresses that sufficiently qualified experts should be on device classification panels, and part of this involves closer interaction between panels and medical device companies. Sponsors will have the chance to recommend clinically relevant experts to fill panel positions, to correct misstatements, as well as give clarifying information.
In vitro diagnostics will have revised barriers for CLIA Waivers
The 1988 Clinical Laboratory Improvement Amendment (CLIA) regulates laboratory testing and requires that clinical laboratories obtain a certificate depending upon the complexity of the tests it performs. Simple in vitro diagnostic (IVD) tests that carry little risk are eligible for a FDA CLIA Waiver, meaning labs may operate low risk IVDs without obtaining a certification for complex testing.
Per the Cures Act, within the next year the FDA will update the CLIA regulatory guidance clarifying which diagnostic tests qualify for a Waiver and revise the criteria for measuring a device’s accuracy. More flexible CLIA guidelines may mean that additional IVD tests can obtain a Waiver.
Multicenter device trials and HUDs rationalize IRBs
Previously, each site in a multicenter device clinical trial or facilities wanting to use a HUD was required to gain approval from their own institutional review board (IRB). The Cures Act eliminates that requirement, reducing redundant review by allowing for reliance on a single, lead IRB for all participating sites.
Certain medical related software will not be FDA regulated
Many kinds of software for managing health data, like programs for healthcare administrative support or for handling certain medical records, will be exempt from FDA regulation. However, the FDA will still regulate software that poses significant risk to patients, such as software used for active patient monitoring.
Do you have more questions? See our white paper on key differences in clinical trials for drugs vs. devices, or tell us what you’d like to know about trends, best practices, and potential opportunities resulting from the Cures Act.