21st Century Cures Act and Medical Device Regulatory Pathways

December 09, 2016

These seven key provisions will affect the premarket requirements for medical devices.

The US Senate passed the 21st Century Cures Act on December 7, and President Barack Obama is expected to sign the bill into law. Included in the legislation are several provisions that affect medical device premarket pathways and the US Food and Drug Administration’s (FDA’s or the Agency’s) obligations related to device premarket issues.

We have summarized below the seven key provisions that will affect the premarket requirements for medical devices.

Breakthrough Devices (Section 3051)

The legislation establishes a program to expedite the development of devices considered “breakthrough” technologies. This new program builds on the existing Expedited Access Pathway (EAP) program, as described in FDA’s April 2015 guidance document.

Breakthrough technologies include devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions and devices that meet unmet needs. The new program is open to devices proceeding through the 510(k) pathway, as well as the premarket approval and de novo pathways. The benefits of designation as a “breakthrough” device include assignment of a specific team of FDA staff; interactive and timely communication with FDA during the development and review process; expedited review of manufacturing and quality systems compliance, as applicable; and a process for written agreement to clinical protocols that will be binding on FDA and sponsor.

In its first year, the existing EAP program accepted 17 devices. By adding 510(k) devices, the legislation provides for a larger pool of potentially eligible devices. As with the EAP program, the new program under this legislation does not include any timelines for review of submissions for breakthrough devices.

Humanitarian Device Exemptions (Section 3052)

This provision will expand the availability of the humanitarian device exemption (HDE). Currently, to obtain an HDE, a sponsor must pursue an indication for a device intended to treat a disease that affects no more than 4,000 people. This is a significant difference from the orphan drug development program, which has a disease ceiling of 200,000 people. Some have expressed concerns that the HDE ceiling has significantly limited the effect of this program; only 10 HDEs were approved in 2014 and 2015. To address this issue, the statute will increase the HDE ceiling to 8,000 people.

Recognition of Standards (Section 3053)

The legislation provides that any person may submit a request for recognition of all or part of an appropriate standard established by a nationally or internationally recognized standard organization, and requires FDA to make a determination on recognition of the standards within 60 days. FDA is required to issue guidance on the principles for recognizing standards. Significantly, to help ensure that standards can be used effectively to meet premarket submission data requirements, the legislation requires FDA to provide training to its employees who review device premarket submissions on the concept and use of recognized standards to meet premarket submission requirements.

510(k) Exemption Process for Class I and II Devices (Section 3054)

This provision requires FDA to publish in the Federal Register lists of Class I and II devices (by product code) that no longer require 510(k) clearance every five years and to implement the exemptions. The first such lists of Class I and II devices must be published no more than 90 days (for Class II devices) and 120 days (for Class I devices) after the legislation’s enactment. In August 2015, FDA published a guidance that included a list of more than 100 Class I, Class II, and unclassified device types for which the Agency did not intend to require 510(k)s. These exemptions have not been promulgated in rulemaking, but presumably would be included in the first lists published after the legislation is enacted.

Classification Advisory Committee Meeting (Section 3055)

This provision is intended to ensure that an FDA advisory panel considering device classification has the appropriate clinical and/or technological expertise with respect to the relevant device types. The new law requires that FDA allow sponsors, patients, and patients’ representatives to provide recommendations for persons with the appropriate expertise to fill the positions on the panels.

Least Burdensome Requirements (Section 3058)

Section 513 of the Federal Food, Drug, and Cosmetic Act, as amended by the Food and Drug Administration Modernization Act of 1997, currently provides that FDA shall consider the “least burdensome” means of evaluating device effectiveness or substantial equivalence for devices that are the subject of premarket approval applications or 510(k) premarket notifications. In 2002, FDA published guidance, The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles, describing the circumstances when nonclinical data or clinical data from novel study designs potentially could be used to shorten the time required to generate data to support approval or clearance.

Because the existing statutory requirement and guidance have not resulted in consistent or meaningful application of least burdensome principles, the new legislation requires that FDA provide training for its employees on the “meaning and implementation of the least burdensome requirements,” conduct an audit of the training, and perform periodic assessments of the implementation of the least burdensome requirements. Additionally, the new provisions require that FDA consider the role of postmarket information in determining the least burdensome means of demonstrating a reasonable assurance of safety and effectiveness.

Combination Products Innovation (Section 3038)

These provisions are intended to address concerns about the complexity and length of the combination product review process and to clarify the criteria for FDA’s drug versus device classification decisions. The Office of Combination Products (OCP) has been criticized for over classifying products as drugs, even in cases where there was long-standing FDA precedent for the classification and regulation of the products in question as devices. These issues were brought to the forefront during the litigation brought by a French company, Prevor, against FDA regarding its skin wash product. In this case, the parties litigated for more than two years the issue of whether Prevor’s product had a drug primary mode of action due to its “chemical action” on the human body, with FDA taking the position that any chemical action rendered the product a drug, regardless of whether the primary mode of action was principally achieved by other means (e.g., via physical action).

The legislation states that FDA shall not determine that a combination product’s primary mode of action is that of a drug or biological product solely because the product has any chemical action within or on the human body. In addition, the new law provides that the sponsor may propose one or more studies to establish the relevance of the chemical action in achieving the primary mode of action.

To help streamline the combination product review process, the new provisions allow FDA to take into account prior findings of safety and effectiveness of a combination product’s approved or cleared constituent parts. The legislation also sets forth a dispute resolution process when two product centers do not agree and establishes procedures for OCP intended to ensure timely and efficient review of combination products. Finally, the legislation states that, no later than 18 months after enactment, FDA shall identify types of combination products and manufacturing processes for which good manufacturing processes may vary from those set forth in FDA regulations.


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Michele L. Buenafe