United States: FDA: Examining Medical Device Provisions

The US Food and Drug Administration (FDA) related portions of the 21st Century Cares Act, found in title III, establish a streamlined process for the exemption of certain Class I and II devices from the premarket notification requirement and allow for the establishment of revised regulatory standards for accessories to high-risk devices. The law also increases the number of diseases for which the humanitarian device exemption (HDE) may be applicable, aids sponsors of breakthrough devices by expediting the review process and alters FDA's authority to regulate certain types of medical software. Moreover, the device-related provisions enhance transparency with respect to FDA's decision whether to recognize international or national standards, and by giving industry representatives increased opportunities to participate in and influence device classification panel meetings. The legislation contains portions of several bills that were previously introduced, but not advanced by the Senate, including:

  • FDA Device Accountability Act of 2015,
  • Preventing Superbugs and Protecting Patients Act,
  • Advancing Breakthrough Devices for Patients Act of 2016,
  • Patient-Focused Impact Assessment Act of 2016, Combination Products Regulatory Fairness Act of 2016,
  • Medical Electronic Data Technology Enhancement for Consumers' Health (MEDTECH) Act, and
  • FDA and NIH Workforce Authorities Modernization Act.

Overview of the Medical Device Provisions in the Cures Act

The device provisions are generally friendly to device manufacturers, with one notable exception—manufacturers of reusable devices. (Reusable devices came under scrutiny for their association with multi-drug resistant bacteria and a number of patient-to-patient infections linked to cleaning and reprocessing of the devices.) In general, the Cures Act provisions seek to:

  • Expedite the review process for breakthrough devices;
  • Extend the HDE to devices intended to treat a broader range of conditions;
  • Streamline the process for exempting certain devices from the premarket notification requirement;
  • Reduce burdens for manufacturers seeking Clinical Laboratory Improvement Amendments of 1988 (CLIA) waived status for in vitro diagnostic (IVD) kits;
  • Clarify FDA's authority to regulate medical device software;
  • Clarify FDA's requirements for reusable devices, and position regarding when a 510(k) is required to be submitted for a modification to a device already on the market; and
  • Enhance transparency in a number of areas, including recognition of international standards and participation in device classification panels.

Why These Provisions Matter


The expansion of FDA's existing priority review program for breakthrough devices for which there is no approved or cleared device currently on the market will benefit sponsors that receive a breakthrough designation. In addition to the potential benefits associated with the expedited review process, the new law provides that FDA may enter into a binding agreement with breakthrough device sponsors that addresses clinical protocols that could support an application for premarket approval or a 510(k) or de novo submission— and once the agency and a sponsor reach an agreement on trial design, FDA will encounter procedural hurdles if it decides to require changes to the protocol. Changes must be agreed to by both parties or FDA must meet with the sponsor to discuss a substantial scientific issue essential to determining the device's safety or effectiveness and issue a decision that such issue exists.

Manufacturers of devices that treat or diagnose conditions that affect 8,000 or fewer individuals in the US each year may benefit from the law's expansion of the HDE. Under the HDE, FDA may grant an exemption from effectiveness requirements for devices designed to treat or diagnose rare diseases for which no comparable device is available. The number of the devices distributed under a HDE must not exceed the number of devices reasonably needed to treat, diagnose or cure a population of not more than 8,000 individuals in the United States—prior to the Cures Act, the threshold was 4,000. Diseases that affect between 4,000 and 8,000 individuals in the US each year include tuberculosis and cerebral palsy, according to the National Organization for Rare Disorders. By increasing the potential populations that may be treated by a device available under an HDE, the Cures Act may increase utilization of the HDE pathway, which has historically been low. FDA's issuance of an accompanying guidance may help applicants provide information that will speed up the review process for HDEs, which has historically been lengthy.

Manufacturers of Class I and II devices may benefit from a provision that requires the agency to regularly re-evaluate whether such products should be subject to the 510(k) requirement. For those devices for which FDA decides not to require premarket notification, manufacturers will further benefit from a provision that streamlines the rulemaking requirement for making conforming revisions to applicable regulations. The procedures set forth in the Cures Act potentially expedite, by several years, the effective date of any FDA decision to not require premarket notification. As a result, the Cures Act appears to incorporate by statute the policy that FDA set forth in a 2015 guidance, which explained the agency would not enforce 510(k) requirements for Class I or II devices listed in the guidance, though FDA had not issued a final rule to amend its classification regulations.


Sponsors of premarket approval applications may benefit from Congress's renewed emphasis that FDA consider the least burdensome means to meet agency needs when evaluating premarket submissions. Although the Cures Act does not change the standards for premarket approval, the law indicates FDA should consider the role of postmarket information when determining the least burdensome means of demonstrating a reasonable assurance of device safety and effectiveness.

Manufacturers IVD kits are the beneficiaries of a provision that requires FDA to revise a specific section of an existing guidance on CLIA waiver applications. FDA has the authority to grant a test waived status under CLIA—and therefore make the test eligible for performance in a laboratory operating under a CLIA Certificate of Waiver—if the test is simple and has an insignificant risk of producing an erroneous result. FDA assesses whether a test has an insignificant risk of producing an erroneous result, in part, by evaluating whether the test produces accurate results when used by a waived user. Under the current version of the guidance, FDA evaluates accuracy by comparing the test's performance when used by a waived user to certain statistical guardrails that may or may not be clinically relevant based on the test's intended use. The Cures Act requires FDA to use a different, potentially less restrictive comparison when evaluating a test's accuracy—i.e., the test's performance when performed by a moderate complexity user. This change will likely require FDA to approve waiver applications for additional IVD kits.


The Cures Act contains three provisions aimed at specific devices or accessories. First, 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. Second, manufacturers of certain types of medical software may benefit from the enhanced regulatory clarity provided by a provision that explicitly excludes certain general software functions from FDA regulation. Third, manufacturers of accessories intended to be used with devices that require premarket approval or a 510(k) submission may benefit from the inclusion of an explicit statutory provision that allows FDA to down-classify accessories based on their intended use, as opposed to the classification of the device with which the accessory is intended to be used.


Manufacturers that comply with internationally recognized quality requirements may benefit from a new provision that sets forth enhanced procedures with respect to the recognition of such standards. Though the Cures Act does not change the existing process that enables FDA to recognize an international or national standard, the law requires the agency to be transparent in its rationale for recognizing, or declining to recognize, such standards. Under the new law, stakeholders may submit a request for the recognition of all or part of a standard created by an international or national standards organization. FDA must decide whether to recognize all or part of that standard and issue a publicly available rationale for the agency's determination. Although FDA may continue its non-recognition of well-recognized international standards (e.g., ISO 13485), requesters will be able to comprehend and possibly better respond to the agency's concerns once its rationale is made public.

The Cures Act will assist device industry representatives by providing enhanced transparency in the voting membership of device classification panels, which now must include individuals knowledgeable about technology and with clinically relevant expertise. The law does not change existing membership requirements or the types of organizations who may nominate individuals for the panels, but instead permits patients, patient representatives and device sponsors to recommend individuals with appropriate expertise for voting member positions. Industry representatives will be afforded additional opportunities during a panel meeting to correct misstatements, provide clarifying information and respond to questions from the panel.

What Is Required by These Cures Act Provisions


Section 3051 of the Cures Act gives FDA explicit statutory authority to extend the existing priority review program for breakthrough devices to 510(k)s and de novo submissions. (Previously, in a guidance document, FDA extended the priority review program to 510(k) and de novo submissions due to the potential public health importance of devices warranting priority review status.) The Cures Act also codifies criteria for determining what constitutes a breakthrough device, and provides specific examples of significant, clinically meaningful advantages that reflect the guidance document. Section 3052, which expands eligibility for the HDE, requires FDA to issue a draft guidance defining a "probable benefit" to health from the use of the device. To obtain a HDE, the probable benefit to health must outweigh the risk of injury or illness.

Section 3054 requires FDA to identify and list any Class I or II devices that are exempt from the premarket notification requirement and update these lists at least every five years. FDA must publish initial lists of Class I and II devices in the Federal Register within 120 and 90 days, respectively, of the law's enactment. Previously, FDA was not statutorily required to update the list of Class II devices on a regular basis, or publish a list of Class I devices for which premarket notification is not necessary to assure safety and effectiveness, though the agency made a one-time commitment to identify 510(k) exempt devices during the last device user fee reauthorization.


Section 3057 requires FDA to issue revised guidance on certain aspects of consideration for designation as a CLIA-waived IVD. Section 3058 instructs FDA to consider the least burdensome appropriate means necessary in requesting information related to premarket approval applications. The agency's summary of the scientific and regulatory rationale for significant decisions regarding submission or review of reports or applications must now include a statement on FDA's consideration and application of least burdensome requirements. Additionally, FDA employees involved in reviewing premarket submissions must receive training on the least burdensome requirements.


Section 3059 requires FDA to finalize a draft guidance describing when a manufacturer must submit a 510(k) for a modification or change to a device already on the market. Regulated industry has waited years for a revised guidance, as the current version dates to 1997 (and an earlier update was withdrawn in 2012). The Cures Act requires the agency to finalize the guidance by November 7, 2017.

Section 3060 carves out five types of medical software functions that will not be treated as devices: devices (1) for administrative support (i.e., claims); (2) for maintaining and encouraging a healthy lifestyle, but unrelated to the diagnosis, cure, prevention or treatment of a disease or condition; (3) that serve as electronic patient records if the records are part of certified health information technology; (4) for transferring, storing, converting or displaying clinical laboratory test or other data and results; and (5) for displaying, analyzing or printing medical information (other than medical images, signals from IVDs or signal acquisition systems), supporting or providing recommendations about prevention, diagnosis or treatment, if the health care professional may independently review the basis for the recommendations and is not intended to rely primarily on the recommendations to diagnose or treat patients. However, FDA may regulate some of the exempted software if the agency makes a finding that the software function would be reasonably likely to have serious adverse health consequences. To regulate exempted software, FDA must publish its finding, the agency's rationale, and a proposed order; accept comments; and publish a final order.


Section 3053 requires FDA to train its employees on the concept and use of recognized national or international standards for the purpose of meeting premarket submission or other requirements. FDA must also review and, if necessary, update existing or previously issued guidance and standard operating procedures that identify the principles for recognizing, or withdrawing recognition of, standards. Under existing law, FDA secures recommendations regarding the classification of devices into Class I, II or III from a panel of experts. Section 3055 adds a new membership requirement for the classification panels to ensure the panels have "adequate expertise," which the Cures Act defines as two or more voting members with a specialty or other expertise clinically relevant to the device under review and at least one voting member knowledgeable about the device's technology.

Action Steps For Device Manufacturers And Other Stakeholders

Sponsors interested in the breakthrough device pathway should begin to evaluate the extent to which existing data enables the sponsor to make a compelling argument under the criteria listed in Section 3051. If such data is lacking, sponsors should take steps to generate such data and arguments.

Device manufacturers should begin tracking the times when they believe FDA has required an unreasonable amount or type of information in order to support an application and consider invoking the new least burdensome review provision. Although FDA is not required to accept less data than is currently needed to support a submission, a sponsor of a device can use the language added by Section 3058 as leverage in negotiations with FDA over the amount and types of information required.

Finally, insofar as many of the above provisions require FDA to take steps to implement the changes envisioned by Congress, stakeholders should consider participating in public meetings or other outreach efforts by FDA to develop or revise applicable guidance documents.

FDA: Examining Medical Device Provisions

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