21st Century Cures Act into law. Most of what people will be hearing from the media will be focused on the Act’s support of cancer research, mental health policies, brain research to tackle diseases like Alzheimer’s and the funding allocated for these initiatives. However, the 996-page bill also includes major changes that impact the way the FDA regulates drugs, devices and biologics.
Those who have spoken out against the Cures Act have done so out of fear of a weakened system that would allow for less rigorous examination of products before they go to market. While there are sections of the act that appear to streamline submission and review processes, until the FDA develops the necessary guidances based on their interpretation of the requirements, the industry will not know what to expect.
The best way to approach these pending changes is to become familiar with the areas that might impact your device. The following summarizes provisions relevant to medical device companies:
Sec. 3001 Patient Experience Data
Under the Cures Act, FDA would be required to include a statement regarding any patient experience data that was used at the time of a drug’s approval. The bill defines patient experience data as “data collected by any persons (including patients, family members and caregivers of patients, patient advocacy organizations, disease research foundations, researchers, and drug manufacturers).” While this section specifically refers to drugs, this may come into play for combination products, as well. This requirement, as well as section 3002, is one to watch to determine if it affects your product commercialization goals.
Sec. 3033 Accelerated Approval for Regenerative Advanced Therapies
This section allows FDA to grant accelerated approval for regenerative therapeutic products and directs FDA to consider the unique characteristics of such therapies and provide a rationale with a determination of whether or not to grant accelerated approval. However, the Act specifically states that this does not change the standards of evidence or limit any other of the authorities of FDA.
Sec. 3034 Classification of Devices used with Regenerative Advanced Therapies
Devices used with a regenerative therapeutic product will be considered moderate risk devices, unless it is determined that the device or its intended use requires a higher risk classification.
Sec. 3035 Updated Regenerative Medicine Guidance and Regulations
Manufacturers of regenerative therapeutic products should be on the lookout for updated guidance and regulations from the FDA.
Sec. 3038 Combination Product Innovation
This section aims to improve the regulation of combination products, which contain both a drug or biologic and a device, by requiring that FDA meet with sponsors and agree early in development how to best study the combination product to meet the standard for approval.
This section also clarifies how dispute resolutions work when the different centers of FDA do not agree, and it includes provisions for reporting on combination product regulations.
Sec. 3051 Breakthrough Devices
As FDA’s Center for Devices and Radiological Health (CDRH) has worked to create a new expedited access program for breakthrough devices, this section of the bill establishes a breakthrough device pathway, which builds on the already established Expedited Access Pathway. Breakthrough devices are considered to provide more effective treatment or diagnosis of life threatening or irreversibly debilitating human disease or conditions with innovative technologies for which no cleared or approved alternatives exist or that offer significant advantages over existing devices.
Sec. 3052 Humanitarian Device Exemption
The current HDE program allows for the approval of devise that address rare diseases or conditions that show “probable benefit” versus “effectiveness.” The FDA will now have the authority to apply the humanitarian device exemption to devices that treat diseases and conditions that affect up to 8,000 individuals in the US. The current cap is 4,000 annually.
Sec. 3053 Recognition of Standards
This section establishes a process at FDA for the submission, review and recognition of standards established by a nationally or internationally recognized standard organization for purposes of medical device review. The FDA must provide a public ruling within 60 days on recognition of a standard, which should lead to increased harmonization globally.
Sec. 3054 Certain Class I and Class II Devices
In early 2017 and then once every 5 years, FDA will be required to review Class I and Class II devices to consider whether they may be declared 510(k) exempt with assurance of safety and effectiveness. The FDA will publish a list of the newly exempted devices for public comment and finalization.
Sec. 3055 Classification Panels
This section aims to improve FDA’s device classification panel review process to ensure adequate expertise among panel members to assess the device and allow for presentation by the device sponsor to the panel, among other things. FDA must also provide an opportunity for the company whose device is being reviewed to provide recommendations on the expertise needed among voting members of the review panel.
Sec. 3058 Least Burdensome Device Review
Divisions of the FDA, such as CDRH, must comply with a statutory requirement to review only data necessary for making a decision of substantial equivalence or device effectiveness by way of the “least burdensome means.” CDRH reviewers are now required to receive training regarding the meaning and implementation of “least burdensome requirements.” Additionally, the FDA’s CDRH ombudsman must conduct an audit with respect to the training and implementation of the least burdensome requirements and to ensure they are fully and consistently applied. Additionally, FDA reviewers shall consider the least burdensome appropriate means necessary for demonstrating a reasonable assurance of safety and effectiveness when requesting additional information from manufacturers during the pre-market approval process. This provision also provides specific requirements as it relates to FDA requests for information from a PMA applicant.
Sec. 3059 Cleaning Instructions and Validation Data Requirement
Following several serious patient issues linked to disease transmission between patients from reusable devices that had been inadequately cleaned and the release of guidance from 2015, this section encourages and clarifies that the FDA requires cleaning and validation data for reusable medical devices. Within 180 days of the enactment of the Cures Act, the FDA must publish a list of reusable device types where 510(k) submissions must include validated Instructions for Use and validation data for cleaning, disinfection and sterilization.
This provision also includes a requirement for FDA to finalize its draft guidance “Deciding When to Submit a 510(k) for a Change to an Existing Device.” Device manufacturers should be sure to take note of when this guidance is finalized.
Sec. 3060 Clarifying Medical Software Regulation
There has been a lot of conversation around the degree to which the FDA can and should regulate software. In this provision, five specific categories of medical software have been identified that, given certain conditions, will not be regulated as a medical device by FDA based on their low level of risk to patients. This section also provides FDA with the authority to regulate software in these categories if safety concerns arise.
The FDA says it is ready to work with Congress to implement the provisions outlined in the 21st Century Cures Act. It will be a busy time for the FDA, and medical device manufacturers should be astute to the pending changes as they come into effect. If you have questions about the Cures Act and how it might impact your medical device company, our regulatory experts are here to support you.
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