In December 2016, the United States passed an important piece of regulatory legislation called the 21st Century Cures Act. These FDA regulations cover multiple types of clinical research but include some specific provisions for medical device development.
In contrast to the regulatory reform seen in the EU — which includes a much-needed increased emphasis on patient safety — new regulations in the U.S. have largely been designed to bring new medical devices to market faster. Take a look at the four major sections aiming to do it.
Breakthrough Devices (Section 3051)
Breakthrough Devices establishes an expedited review pathway for devices intended to treat or diagnose life-threatening or irreversibly debilitating diseases and conditions and offers sponsors enhanced agency collaboration. This is similar to the existing Breakthrough Designation program for drug and biologics and applies to 510(k), de novo petitions, and premarket approval applications
Recognition of Standards (Section 3053)
Under the Recognition of Standards, the FDA will be required to determine and publicly disclose whether a nationally or internationally recognized standard will be officially adopted within 60 days of a submitted request. The goal of this section is to streamline and increase transparency in the regulatory process, as well as to encourage international harmonization.
510(k) Exemption for Class I/II Devices (Section 3054)
Another streamlining effort, under this section, the FDA must publish a list of Class I and II devices that no longer require 510(k) clearance every five years. The goal here is to build in expediency and reduce redundancy in medical device regulation.
Institutional Review Board Flexibility (Section 3056)
Section 3056 removes the requirement that local Institutional Review Boards (IRBs) must approve medical device trials. This doesn’t mean decreased oversight and compromised accountability; instead, IRB Flexibility frees up centralized IRBs to take on this role, further expediting medical device research and development.
Read more on this topic by watching our latest medical device webinar.