These initiatives are aimed at better defining practices already in use by the agency, as well as adding clarity around advancing technology approvals moving forward.

The FDA regulates over 190,000 different medical devices, which are manufactured by more than 18,000 firms in approximately 21,000 medical device facilities worldwide. The recent guidance releases mark the latest policy initiatives designed to strengthen review and approval processes to better accommodate rapid gains in device technologies and capabilities.

The agency’s overall modernization strategy was outlined in its Medical Device Action Plan in April 2018. In a joint statement in late 2018, then FDA Commissioner Scott Gottlieb, MD, and CDRH Director Jeff Shuren, MD, said the agency was committed to staying ahead of rapid changes in medical device technology.

“Advances in material science, digital health, 3D printing, and other technologies continue to drive an unparalleled period of invention in medical devices,” the statement said. “It’s vital that the FDA’s regulatory approach continue to evolve and modernize to safely and efficiently advance these opportunities. Not only must we keep pace with this complexity and innovation, but we must also stay ahead of new and evolving risks that sometimes accompany this progress.”

New Directions for 510(k)

Chief among the recently released guidelines is a new framework for the 510(k) pathway. The 510(k) pathway is used for low- to moderate-risk devices that are substantially equivalent to a predicate device already on the market and is the FDA’s most common premarket approval mechanism. According to the FDA, CDRH cleared 3,173 devices through the 510(k) pathway in 2017, representing 82% of total device clearances.

The proposed changes to the 510(k) pathway are designed to push innovators toward a greater reliance on modern predicate devices or objective performance criteria when seeking to bring new devices to patients rather than relying on outdated predicate devices, according to FDA.

“Older predicates might not closely reflect the modern technology embedded in the new devices or our more current understanding of device benefits and risks,” said Gottlieb and Shuren in their joint statement last year.

“Sometimes, by relying on old predicates, it can actually make it more difficult for more advanced technology to reach patients, since it’s harder for an innovative product to bridge to an outdated technology reflected in a decades-old predicate.”

The 510(k) pathway now includes 3 types of premarket notification:

• Traditional: For any original 510(k) submission; typically requires the greatest amount of information and generally is used when other pathways do not apply
• Special: Secures FDA approval for changes to an existing device a device innovator already manufactures
• Abbreviated: Relies on consensus standards or FDA guidance documents to demonstrate substantial equivalence

An expansion of the Abbreviated 510(k) pathway is the Safety and Performance Based Pathway for certain, well-understood device types. This proposed pathway was released in September and is available contingent upon a submitters’ ability to demonstrate that a new device meets FDA-identified performance criteria and is as safe and effective as a legally marketed device, according to the FDA.

De Novo Pathway Updates

Historically, device innovators rarely used the De Novo pathway. However, the FDA is pushing for greater utilization of the pathway, which is designed for premarket review of novel, low-to-moderate-risk devices that are not substantially equivalent to a predicate device.

The FDA believes clearing devices through this pathway would establish new predicate devices, reflecting modern standards of performance and safety and serving as the basis for future clearances. Proposed changes announced last year are aimed at providing additional structure, clarity, and transparency to the De Novo approach, according to the agency.

“Our goal is to make the De Novo pathway significantly more efficient and transparent by clarifying the requirements for submission and our processes for review,” said former FDA Commissioner Gottlieb. “As a result, we expect to see more developers take advantage of the De Novo pathway for novel devices.”

Key elements of the proposed changes include:

• Acceptance review: Detailed guidance and checklists for determining if a De Novo application fulfills a minimum threshold of acceptability and should be accepted for review
• Review clock: A description of the FDA’s timing and action objectives for De Novo applications as delineated in the Medical Device User Fee Amendments 2017 (MDUFA IV)
• User fees: An explanation of updated fee rates and payment procedures for medical device user fees in fiscal year 2020 as amended by MDUFA IV

Clarity on Software as Medical devices (SaMD)

Though the FDA has not issued an overarching software policy, it has formally classified certain types of software applications as devices. The FDA intends to exercise regulatory oversight over certain device software functions that may pose unique risks to consumers.

The 21^st Century Cures Act excludes certain software functions from the definition of a device in section 201(h) of the Food, Drug, and Cosmetic (FD&C) Act. Specifically, software functions that meet all of the following criteria will be exempt from the definition of device: software functions that are (1) not intended to process a medical image from an in vitro diagnostic device; (2) intended to display or analyze medical information about a patient; (3) intended to provide recommendations to a healthcare professional concerning treatment of disease; and (4) intended to enable healthcare professionals to independently review said recommendations and not rely solely on these recommendations for clinical diagnoses.

Recent FDA guidance updates specific to software include:

• Changes to existing medical software policies: The final guidance detailing changes relating to the regulation of software and the removal of certain software functions from the definition of the term device state that the term device will no longer include software that is (i) intended for administrative support of a health care facility; (ii) unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease; (iii) used to store electronic patient records; or (iv) used for storing or displaying clinical laboratory tests. Such software functions are not considered devices and are not subject to FDA laws and regulations applicable to devices.
• Policy for Device Software Functions: “Device Software Functions” refer to software functions that are device functions, including SaMD. This guidance differentiates the subset of software functions to which the FDA intends to apply its authority. Specifically, regulatory oversight will be applied only to software functions that are medical devices and whose functionality could pose risk to patient safety. These updates are consistent with amendments to the FD&C Act from the 21^st Century Cures Act. The guidance also provides oversight on mobile medical applications (apps) that are intended to be used as an accessory to a medical device or to transform a mobile platform into a regulated medical device.
• Policy on Medical Device Data Systems: The FDA released a final guidance to outline Medical Device Data Systems (MDDS) that pose a low risk to the public. Device-MDDS refers to hardware, while Non-Device-MDSS refers to software that function to transfer, store, convert formats, and display medical device data. Non-Device-MDDS are used without controlling or altering the functions of connected medical devices, which may or may not be intended for active patient monitoring. Under section 201(h) of the FD&C Act, Non-Device-MDDS are not regulated as devices while Device-MDSS are.
• Clinical Decision Support (CDS) Software: A software function is considered CDS if it is not intended to process or analyze data but to display medical information and support or provide recommendations to health care providers. The draft guidance clarifies the types of CDS software functions that (i) do not meet the updated definition of a device, (ii) meet this definition but are not the focus of regulatory oversight due to analysis of risks of these devices, or (iii) meet the definition of device upon which FDA intends to focus. Risk-based policies are applied to the CDS software functions using the International Medical Device Regulators Forum Framework, which characterizes the use of SaMD based on the significance of the information provided to a healthcare decision and the state of the patient’s healthcare condition.
• Off-The-Shelf (OTS) Software Use: This final guidance outlines the step-by-step decision process for OTS software and describes information that should be provided in a device application involving OTS software. The CDRH suggests that engineering risk management for medical device software should focus on the severity of harm that could result from software failures, rather than software failure rates alone.

Safer Technologies Program (STeP)

In addition to modernizing individual pathways, the FDA introduced the STeP for medical devices that have the potential to be significantly safer than currently available treatments or medical diagnostics.

Like the previously announced Breakthrough Devices Program, STeP incorporates interactive and timely communication with the FDA, review team support, senior management engagement, and prioritized review. The FDA believes interactive and expedited feedback may reduce the cycle time for developing a device and achieving market authorization while still ensuring agency standards for safety and effectiveness are met.

Devices and device-led combinations are eligible for STeP if they are subject to review under a premarket approval application, De Novo classification request, or premarket notification 510(k), and meet other program eligibility factors as described in the draft guidance.

Pathways to the Future

The accelerating velocity of innovation in the medical device arena requires a new framework for understanding, assessing, and approving healthcare technologies. CDRH released a flurry of guidance documents clarifying its expectations regarding device regulation at the end of 2019 to comply with the FD&C Act.

To learn more about how the FDA’s guidance may affect your organization or product, contact Avalere.

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