Life Science Compliance Update

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November 08, 2017

FDA Provides Guidance on Medical Devices


Recently, the FDA released two final guidances and a new draft guidance to increase the regulatory clarity around medical devices, including software as a medical device. The agency also announced the first qualified tool under the voluntary Medical Device Development Tools (MDDT) program.

Final Guidances

The two final guidances released are designed to help developers understand when a modification to a device — which would include a software update — requires a new 510(k) clearance. The guidances, "Deciding When to Submit a 510(k) for a Change to an Existing Device” and “Deciding When to Submit a 510(k) for a Software Change to an Existing Device,” update a similarly-named guidance document from 1997.

For the guidance related to change to an existing device, it uses flowcharts and text to guide manufacturers through the logic scheme FDA recommends to arrive at a decision on whether to submit a new 510(k) for a change to an existing device. A single logic scheme containing all the necessary steps would be large and cumbersome and could be quite daunting.

This guidance will aid manufacturers of medical devices subject to premarket notification requirements who intend to modify a 510(k)-cleared device (or group of devices) or other device subject to 510(k) requirements, such as a preamendments device or a device that was granted marketing authorization via the De Novo classification process under section 513(f)(2) of the FD&C Act during the process of deciding whether the change exceeds the regulatory threshold for submission and clearance of a new 510(k).

Related to the other guidance, FDA issued the original guidance Deciding When to Submit a 510(k) for a Change to an Existing Device on January 10, 1997 to provide guidance on regulatory language. As stated in that guidance, the key issue in the interpretation of 21 CFR 807.81(a)(3) is that the phrase “could significantly affect the safety or effectiveness of the device” and the use of the adjectives "major" and "significant" sometimes lead FDA and device manufacturers to different interpretations.

The original guidance provided the FDA’s interpretation of these terms, with principles and points for manufacturers to consider in analyzing how changes in devices may affect safety or effectiveness and determining whether a new 510(k) must be submitted for a particular type of change. The current guidance preserves the basic format and content of the original, with updates to add clarity. The added clarity is intended to increase consistent interpretations of the guidance by FDA staff and manufacturers and provide a more transparent framework for determining when submission of a new 510(k) is required.

Draft Guidance

The draft guidance describes the FDA's new Breakthrough Devices Program, which will supersede the agency's Expedited Access Pathway. The program, which allows novel technologies that present a significant improvement over the status quo to move more quickly through the clearance process, was created in the 21st Century Cures Act that passed last year.

MDDT Program

According to Commissioner Gottlieb, the agency completed its “first qualification of a medical device development tool (MDDT) to provide a more objective platform for developing devices in a key area of medicine – cardiovascular health. Fostering the creation and validation of development tools that can be used to provide more efficient and accurate ways to measure risk and benefit, as part of the medical product development process, is a key goal of the FDA. At the FDA, we’re undertaking a comprehensive policy effort to facilitate the development and validation of these kinds of medical device development tools.”

He continues: “Today’s newly qualified MDDT is a 23-item questionnaire that measures health information that is reported directly by patients with heart failure. The tool can be used to measure a heart failure patient’s health status, including clinical symptoms and the physical and social limitations caused by this condition. Such a tool has the potential to help engineers designing heart failure devices to more efficiently and accurately quantify how much their device could actually improve a patient’s quality of life. By qualifying the tool under the FDA’s new, voluntary program, it will make it easier for product developers to rely on the outputs of this newly qualified tool as part of their development plans. Innovators can trust in advance that the agency has already found the outputs of these measures to be reliable.”

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