21st Century Cures

The 21st Century Cures Act (P.L. 114-255) is landmark, bipartisan legislation that was signed into law on Dec. 13, 2016, and touches virtually all aspects of biomedical research, medical product development and the regulatory approval process. Read what FasterCures has said about 21st Century Cures over the years.

FasterCures worked closely with Congress, federal agencies and the advocacy community throughout the legislation’s journey to the president’s desk. In February 2017, we debuted the 21st Century Cures Tracker to track the implementation of the 100+ sections in Division A, which include the key provisions relevant to biomedical research and innovation. (Other divisions of the law pertain to mental health and Medicare; since those are not areas of focus for FasterCures, we will not be actively tracking them here.) Learn more about how to use the tracker with our FAQs page.

A few examples of the issues we will be tracking include the impact of changes to the National Institutes of Health’s administrative requirements for grantees, how the Food and Drug Administration implements new changes designed to enhance patient engagement and how the Department of Health and Human Services is using its new authorities to promote health information technology interoperability.

Many external factors will affect the progress of these initiatives, including policies related to hiring freezes and uncertain funding levels. This tracker is not meant to be a pass/fail report card, but rather a snapshot in time that can help explain impact and identify where progress is needed.

Please keep coming back, as we will be updating the information regularly. Use the button below to send us feedback on the value of the information we are presenting, and the usability of this new resource.

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FasterCures' 21st Century Cures Act Tracker (P.L. 114-255)

Status Section Tracked Deadlines and Requirements Update Date of Update Tags
fa fa-2x fa-long-arrow-right Sec. 3051. Breakthrough devices. 12/13/2017: requires FDA to issue guidance on the implementation of the medical device review pathway established by this provision.
1/1/2019: requires FDA to issue a report to Congress on the new medical device review pathway and opportunities for improvement.

10/25/2017: FDA announced the availability of draft guidance entitled “Breakthrough Devices Program; Draft Guidance for Industry and Food and Drug Administration Staff.”

20171025 10/25/2017 FDA, Medical Devices, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 3052. Humanitarian device exemption. 6/13/2018: requires FDA to issue a guidance document define "probable benefit" in the context of the humanitarian device exemption.

6/7/2017: FDA rule notice in the Federal Register: section 3052 of the 21st Century Cures Act amended section 520(m) of the FD&C Act to allow for HDE approval for devices that, among other things, treat or diagnose a disease or condition that affects “not more than 8,000” individuals in the United States; this threshold had been “fewer than 4,000” individuals in the United States (amending 21 U.S.C. 360j(m), passim). This final rule amends part 814 (21 CFR part 814) in several places to accurately reflect the threshold recently enacted into law.

20170607 06/07/2017 FDA, Guidances, Medical Devices, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 3053. Recognition of standards. Instructs FDA to review and update its guidance on submission and evaluation of independent standards for medical device review.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 FDA, Guidances, Medical Devices, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 3055. Classification panels. Requires FDA to provide an annual opportunity for stakeholders to provide recommendations for individuals with appropriate expertise to fill voting member positions on medical device classification panels

6/23/2017: FDA is requesting nominations for voting members to serve on the Device Good Manufacturing Practice Advisory Committee and device panels of the Medical Devices Advisory Committee in the Center for Devices and Radiological Health.

20170623 06/23/2017 FDA, Medical Devices, Regulatory Affairs
fa fa-2x fa-check Sec. 3056. Institutional review board flexibility. Removes the requirement that a sponsor of medical device trial use a local institutional review board. In effect upon enactment.

6/7/2017: On June 7, 2017 FDA rule notice in the Federal Register: “section 3056 of the 21st Century Cures Act amended section 520 of the FD&C Act to remove the requirement for institutional review committees, i.e., IRBs, for devices to be “local”, (amending 21 U.S.C. 360j, passim). This final rule amends 21 CFR 814.124(a), “IRB approval”, to remove the term “local” and related language in order to accurately reflect the requirements recently enacted into law.”

20170607 06/07/2017 FDA, Medical Devices, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 3057. CLIA waiver improvements. 12/13/2017: instructs CMS to issue draft guidance on CLIA waiver improvements, and issuance of final guidance within one year after comment period closes.

11/29/2017: FDA announced the availability of the draft guidance entitled “Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.” Comments on the draft guidance must be submitted by 1/29/2018. .

20171129 11/29/2017 CMS, FDA, Guidances, Medical Devices, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 3058. Least burdensome device review. 6/13/2018: requires FDA to conduct an audit on training and use of least burdensome requirements during review of medical devices.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 FDA, Medical Devices, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 3059. Cleaning instructions and validation data requirement. 6/11/2017: requires HHS to identify and publish of a list of reusable medical devices that require additional instruction on, and validation of, proper cleaning and disinfection procedures.

6/9/2017: On June 9, 2017 FDA published such a list in the Federal Register. This list becomes effective on August 8, 201

20170609 06/09/2017 FDA, Medical Devices, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 3054. Certain class I and class II devices. 3/13/2017 (and every 5 years thereafter), instructs FDA to publish in the Federal Register a notice that contains Class II devices exempt from reporting requirements due to low risk; followed by 60 day public comment period. Final list published 7/11/2017.
4/12/2017 (and every 5 years thereafter): instructs FDA to provide a list of Class I devices exempt from reporting requirements due to low risk.

11/17/2017: FDA announced it received a petition requesting an exemption from the premarket notification requirements for over-the-counter (OTC) denture repair kits and is receiving comments. 

11/7/2017: FDA published an order to exempt autosomal recessive carrier screening gene mutation detection systems from the premarket notification requirements, subject to certain limitations. 

4/13/2017: FDA issued a notice in the Federal Register identifying a list of class I devices that are now exempt from premarket notification requirements, subjects to certain eliminations. FDA's action will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulation.

3/14/2017: FDA issued a notice in the Federal Register identifying more than 1,000 medical class II devices it is proposing to exempt or partially exempt from the premarket review process. A 60-day comment period is now open, after which FDA may narrow or expand this list.

20171117 11/17/2017 FDA, Medical Devices, Regulatory Affairs

 

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