The 21st Century CURES Act, was signed by President Obama in December 2016 and will impact medical device development, pharmaceutical companies, FDA enforcement and approval processes including the way clinical trials may be used.
The law was designed to increase the speed at which new medical treatments get to market by hastening some of the FDA approval processes, with great detail provided to the FDA on how the organization should proceed, as well has provide additional funding to the NIH for medical research.
One of the requirements that will impact the medical device regulatory process is the establishment of a Breakthrough Device program. This program will help bring technology to market for conditions with no cleared or approved alternatives. The process will build on the Expedited Access Pathway and de novo requests.
Another area with expanded approval authority is the Humanitarian Device Exemption program, which allows approval for devices that treat rare diseases. Previously, the device could be developed to treat a disease that affected 4,000 or fewer people annually; the CURES Act doubles the limit to 8,000 affected annually.
The FDA has a lot of work ahead of it – they are required to review class I and class II devices early this year, and then again every five years, to consider whether they could be declared 510(k) exempt. Another requirement for the FDA is to publish a list of reusable device types where the 510(k) submission must also include instructions for use for the cleaning, disinfection and sterilization of the device. Additional changes in regulation include accessories of devices. Accessories will now be regulated based on their intended use, not upon the parent device with which the accessory will be used.
Pharmaceutical companies will see changes on the way their products are reviewed as well. “Real world evidence” can now be considered by the FDA in addition to randomized clinical trials to approve drugs. Drug makers can also promote off-label use of their products to insurance companies.
There is some concern as to how President Trump’s latest executive order directing federal agencies to cut two regulations for every new one implemented could impact the CURES Act, and the FDA as a whole. This executive order also applies to guidance documents, which medical device manufactures rely upon heavily to ensure conformity of devices to FDA standards. Specific details of the executive order detailing how this rule will be implemented have not yet been released.
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