This week marks the one-year anniversary of a rarity in Washington, DC: enactment of a health care bill with bipartisan majorities in both the House and Senate; support of the Administration; as well as the backing of patients, physicians, hospitals, and the pharmaceutical and medical technology industries.
The 21st Century Cures Act, signed into law Dec. 13, 2016, is one of the most significant pieces of health care legislation in recent years. Designed to accelerate the discovery, development and delivery of life-saving and life-improving therapies for patients, the law includes a number of process reforms at FDA to improve the efficiency and predictability of the drug and medical device review processes as well as significant funding for new health care research at NIH.
In the medical technology arena, the bill included a number of provisions to speed patient access to life-changing innovations. Over the last 12 months, FDA has made steady progress implementing these provisions, working with AdvaMed and other key stakeholders.
- The agency has exempted more than 1,000 low-risk device types from requiring regulatory submissions, freeing FDA resources for work on higher-risk products that have more of an impact on public health.
- All-staff training has been done to ensure a “least burdensome” approach is being taken by FDA personnel when evaluating a medical device or diagnostic, aimed at reducing the regulatory burden of providing unnecessary information in a product submission.
- Perhaps most importantly, FDA recently released guidance to create a new accelerated, seamless review pathway for breakthrough technologies that hold the potential for significant improvements in the treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
These and other provisions – allowing clinical trial approval from a single, central IRB; streamlining FDA’s recognition of consensus standards; doubling the humanitarian device exemption patient cap for rare diseases and pediatric conditions – represent incremental improvements to a complex regulatory oversight system where everything is interconnected.
The medical device provisions of the 21st Century Cures Act work together to move the system in the right direction toward more efficiency, transparency and predictability. That’s good for the agency, good for innovation and good for American patients.
We look forward to working in tandem with FDA and other stakeholders as implementation of this important law continues toward our mutual goal of improving the public health.