‘Cures Act’ Device Provisions Explained

Attorneys Jeffrey Shapiro and Jennifer Newberger (Hyman, Phelps & McNamara) say the 21^st Century Cures Act, approved by lopsided majorities in the House and Senate and expected to be signed by the president, contains “a host of provisions intended to improve how FDA reviews and approves drugs and medical devices.” In their firm’s FDA Law Blog, they summarize some of the device-related provisions: 

•          Breakthrough Devices. FDA is to establish a program for priority review and management attention to devices that provide “more effective treatment or diagnosis of life threatening or irreversibly debilitating human disease or conditions” and that represent “breakthrough” technologies for which no cleared or approved alternatives exist.
•          Humanitarian Device Exemption. Doubles from 4,000 to 8,000 the ceiling for the number of people affected by a disease or condition to qualify for the exemption.
• ·        Review of Class 1 and 2 Devices. Starting in 2017 and continuing once every five years, FDA must review Class 1 and 2 devices and consider whether they may be declared 510(k) exempt with reasonable assurance of safety and effectiveness.
•          Classification Panels. FDA must ensure that any classification panel has “adequate expertise” to assess “the disease or condition which the device is intended to cure, treat, mitigate, prevent, or diagnose” and “the technology of the device.” Companies whose product is being reviewed must be given an opportunity to provide recommendations on the expertise needed among panel voting members.
•          Institutional Review Board Flexibility. A single IRB can oversee a multi-center device trial rather than a separate IRB at each site.
•          CLIA Waiver Improvements. FDA has one year to revise its 2008 guidance on Clinical Laboratory Improvement Amendment waivers for in vitro devices to allow demonstration of accuracy through comparable performance between a waiver user and a moderately complex laboratory user. The attorneys say this provision should make it easier for some IVD tests to be exempted from routine inspections and most CLIA requirements.
•          Least Burdensome Device Review. All CDRH reviewers are to be trained “regarding the meaning and implementation of the least burdensome requirements.” FDA is required to assess implementation of the least burdensome requirements to ensure that they are “fully and consistently applied.” The CDRH ombudsman is to audit the required training with respect to implementing the least burdensome provisions and interview industry representatives to obtain their perspective on application of the least burdensome provisions to premarket review and decision making.
•          Cleaning Instructions and Validation Data Requirement. Within 180 days of enactment of the law, FDA must publish and then revise when appropriate a list of reusable medical device types where 510(k) submissions must include validated instructions for use and validation data for cleaning, disinfection, and sterilization.
•          Clarifying Medical Software Regulation. Several software categories are removed from the definition of medical device.