FDA Outlines When New Clearances Are Needed for Existing Devices

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By Michael D. Williamson

Aug. 5 — The FDA outlined when device makers should submit new premarket clearance requests for existing products in a pair of draft guidance documents posted online Aug. 5.

A manufacturer weighing software changes to an existing device should consult a draft guidance titled “Deciding When to Submit a 510(k) for a Software Change to an Existing Device.” The draft document contains a flowchart industry may use to determine if a new premarket clearance request, also known as a 510(k), is needed if it is considering a software modification.

“This guidance on software represents a very important—and previously missing—piece to the regulatory puzzle,” attorney Bradley Merrill Thompson told Bloomberg BNA Aug. 5. Thompson, an attorney with Epstein Becker & Green PC in Washington, represents device and life science companies.

Companies considering nonsoftware changes to their products already cleared for the market should study a separate draft document, “Deciding When to Submit a 510(k) for a Change to an Existing Device,” to determine if a new 510(k) is needed.

Premarket notification clearances demonstrate that a device is substantially equivalent to another device already on the market. Clinical data typically aren't generated for a 510(k). The 510(k) process is how the FDA allows most devices on the U.S. market. The agency says it generally reviews 510(k) submissions for class II, or moderate-risk, devices.

Comments Due in November

The Food and Drug Administration released a notice (Docket No. FDA-2011-D-0453) set for publication in the Aug. 8 Federal Register to announce the software draft guidance.

A separate notice (Docket No. FDA-2016-D-2021), also set for publication Aug. 8, announced the nonsoftware changes draft document.

Comments on both draft documents are due Nov. 7.

Attorney's Take

The software draft document is important because the FDA has started to clarify when software such as mobile apps is regulated (10 MELR 16, 8/3/16), but it left open the question of when changes to those apps that are regulated prompt the requirement of a new 510(k), Thompson said. However, the software draft guidance finally tackles that issue, he told Bloomberg BNA.

For example, the software draft document specifies it covers all device software, whether the software is embedded in a medical device, serves as an accessory to a medical device or functions as a stand-alone medical device, Thompson said. “We have been sorely in need of this guidance for years, and are delighted to see it.”

However, Thompson said the guidance isn't precise. In many instances, the FDA inserts the word “likely” to qualify statements of whether a 510(k) is required when a device company changes a product's software, he told Bloomberg BNA. This imprecision might be interpreted to sweep many software modifications into needing a new 510(k), Thompson said.

“To be clear, I would not want them [the FDA] to simply strike out the word ‘likely,'” Thompson said. “I'm not in favor of certainty for the sake of certainty. I realize that in many instances, the specific facts matter very much. My only point is that this guidance is intended to clarify the requirements for an industry that is probably not unified in its approach to making these decisions, and is meant to give fair warning to industry before enforcement of this legal requirement.”

When the government has this much trouble stating specifically what is required, it suggests that the government shouldn't be too punitive when companies make a decision in good faith with which the agency disagrees, Thompson said.

`Guiding Principles.'

The software draft guidance outlines several “guiding principles” that industry should consider as it studies whether to change a device's software.

For example, if the software modifications are intended to significantly affect a device's safety or effectiveness, a new 510(k) is likely required, the draft document said.

However, if the software modification is made solely to strengthen a device's cybersecurity and that change doesn't have any other impact on the product, it isn't likely to require a new 510(k) for the product, the FDA said.

The draft guidance describes a number of specific situations when certain software changes would or wouldn't require a new 510(k).

Nonsoftware Guidance

The nonsoftware draft guidance is organized in a similar way to the software draft document.

Modification to a device's label, nonsoftware technology, engineering or performance changes; and material alterations may prompt the FDA to require a new 510(k) for an already cleared product, that draft document said.

In addition, if the device modifications are intended to significantly affect a device's safety or effectiveness, a new 510(k) is likely required, it said.

The nonsoftware draft guidance also includes a flow chart that industry may study to determine when a device change warrants a new 510(k).

Combination Products

Combination products, which combine drug, device and/or biological products into a single unit, aren't covered by either draft document.

Thompson said he was “disappointed to see combination products excluded” from the software guidance.

The FDA's devices center typically excludes combination products from guidance documents when it hasn't consulted the agency's drug center, Thompson said. “We are left to guess for software used in a combination product what the rules look like,” he said, adding, “I'm getting tired of that.”

Thompson also serves as the general counsel of the Combination Products Coalition, an industry group.

To contact the reporter on this story: Michael D. Williamson in Washington at mwilliamson@bna.com

To contact the editor responsible for this story: Brian Broderick at bbroderick@bna.com

For More Information

The draft guidance on device software changes is at http://src.bna.com/hui.

The draft guidance on nonsoftware device changes is at http://src.bna.com/huh.

The notice announcing the device software changes draft guidance is at http://src.bna.com/huD.

The notice announcing the nonsoftware device changes draft guidance is at http://src.bna.com/huG.

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