The 21st Century Cures Act signed into law in December of 2016 attempts to build on FDA’s efforts to advance medical product innovation and improve patient access to treatments while continuing to rely on high-quality evidence to evaluate safety and effectiveness.
The new law includes a number of important provisions specifically relevant for medical device manufacturers, including a streamlined process for exempting certain Class I and II devices from premarket notification requirements and allowing for revised regulatory standards for high-risk device accessories.
The newly passed law also expands the list of diseases for which the humanitarian device exemption (HDE) may apply, expedites the review process for breakthrough devices, and changes the agency’s authority to regulate particular types of medical software.
Additionally, the new law enhances the transparency in regards to FDA’s decisions to recognize national and international standards and provides more opportunities for industry representatives to participate in device classification panel meetings.
New Medical Device Provisions in The 21st Century Cures Act
On the whole, device manufacturers should welcome most of the provisions included in the Cures Act, with the exception of those producing reusable devices, which came under scrutiny for being linked to drug-resistant bacteria and infections passed from one patient to another due to the cleaning and reprocessing of these devices.
Overall, the new law presents six major new provisions device manufactures should be aware of:
1. Faster review of breakthrough devices
Under the newly passed law, FDA may enter into a binding agreement with breakthrough device sponsors to possibly support an application for premarket approval, 510(k), or de novo submission.
[Read Also:] The 4 Steps of the FDA's Premarket Approval Process
If regulators come to an agreement with sponsors on trial design, FDA will face a myriad of procedural obstacles if it decides to require changes to the clinical protocol it had agreed upon.
If a change is not agreed upon by both parties, regulators will need to meet with sponsors to discuss the issues and determine the device’s safety or effectiveness before issuing a final decision.
2. A streamlined process for exempting some Class I and II devices from the premarket notification requirement
Another new device-related provision requires the agency to routinely re-evaluate whether such products should be subject to the 510(k) requirement.
If FDA determines not to require premarket notification, another new provision simplifies the rule making requirement for making conforming revisions to applicable regulations.
[Free White Paper:] FDA Trends & Developments for the Medical Device Industry in 2016
New procedures could expedite the effective date of any FDA decision to not require premarket notification by several years.
3. Fewer hurdles for manufacturers seeking CLIA waved status for in vitro diagnostic (IVD) kits
For companies manufacturing IVD kits, the Cures Act requires regulators to revise a specific section of an existing guidance on CLIA waiver applications, thereby requiring the use of a potentially less restrictive comparison when assessing tests used to grant waived status under CLIA.
The alteration will likely require regulators to approve waiver application for additional IVD kits.
4. An extension of HDE to devices intended to treat a broader range of conditions
For manufacturers of devices that treat or diagnose conditions that affect 8,000 or fewer individuals in the US each year, the new law’s expansion of devices available under an HDE from 4,000 to 8,000 individuals per year makes the HDE pathway a viable option for more companies.
An accompanying guidance gives manufacturers the ability to submit richer information to regulators during the application process, potentially speeding up HDE review.
5. Clearer requirements for reusable devices, medical software, and 510(k) submissions when a modified device is already on the market
The Cures Act presents three important provisions for manufacturers of specific devices.
- Manufacturers of certain reusable devices will be required to include validated instructions for use and validation data regarding the cleaning, disinfection and sterilization of such devices
- A new provision aimed at manufacturers of specific medical software explicitly excludes certain software functions from FDA regulation
(Software categories include, administrative and operational, such as appointment software; wellness, such as apps for tracking exercise; electronic health records; software for transferring, storing or displaying medical device data such as lab data; and clinical decision support software.)
- A new statutory provision allows FDA to downgrade their classification of accessories based on their intended use, as opposed to the classification of the device with which the accessory is intended to be used
6. Greater transparency in recognizing international standards and inclusion in panels for device classification
The new law now requires FDA to be transparent in its reasoning for recognizing, or not recognizing, international standards for which many manufacturers must currently adhere to.
Under a new provision, stakeholders may submit a request for the recognition of all or part of a standard created by an international or national standards organization.
Regulators must then decide whether to recognize all or part of that standard and issue a publicly available rationale for their determination.
The Cures Act also gives individuals with technological knowledge and clinically-relevant expertise voting membership opportunities in device classification panels. The Cures Act does not alter membership requirements or the types of organizations who may nominate individuals for the panels, but permits patients, patient representatives and device sponsors to recommend individuals with appropriate expertise for voting member positions.
Grab our free white paper, FDA Trends and Developments for the Medical Device Industry in 2016 to learn more about recent regulatory initiatives and actionable advice for device manufacturers.