In a new draft guidance issued yesterday the FDA sought to clear up confusion about what types of changes to existing medical devices require new 510(k) submissions.
The watchdog agency outlined changes to the device features, such as labeling, manufacturing and materials, which require a new 510(k) submission, as well as what types of changes don’t need additional agency review.
“We are making the regulatory process for medical devices less challenging by better describing our expectations,” Dr. Jeffrey Shuren, director of FDA’s Center for Devices & Radiological Health, said in a press release. “In particular, manufacturers can continue to make innovative improvements to their devices and better plan for any updated submissions. This saves time and money.”
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MassDevice Staff Website The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
The guidance addresses types of changes that typically warrant a new 510(k) submission for an existing medical device:
- Major changes or modifications to the intended use of the device.
- Manufacturing process changes.
- Specific types of labeling changes.
- Technology, engineering and performance changes.
- Materials changes.
- Is clinical data necessary to determine substantial equivalence?
The document, titled Deciding When to Submit a 510(k) for a Change to an Existing 510(k), replaces the 1997 guidance of the same name, which was issued to clarify the words “significant” and “major” in regard to agency regulation stating that existing devices need new applications in case of:
(i) A change or modification in the device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process.
(ii) A major change or modification in the intended use of the device.”
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The guidance does not address issues concerning nanotechnology, and the FDA recommends that manufacturers contact the agency directly to work out any nano-related changes.
The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
