The Food and Drug Administration is getting high marks from Health IT Now, a coalition of patient, provider, and payer groups, for a potentially streamlined regulatory pathway for software products.
According to HITN, the FDA is considering a “pre-check like system” of quality controls for developers—when it comes to medical device software updates—that is modeled after the Transportation Security Administration’s expedited security screening process at airports.
Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, discussed the concept on Monday as part of a panel at the Digital Health Technology Expo co-hosted by the FDA and the Consumer Technology Association.
Shuren said that the medical device center could explore an approach akin to the TSA Pre-check program. Under such a “FDA pre-check” program, he said developers of software-based technologies may not need premarket review of some modifications that are reviewed today if they demonstrate in advance they are proficient at software design and development for that type of technology.
In response, HITN’s Executive Director Robert Horne commended Shuren for his comments outlining the potential of a system of pre-checked quality controls as a possible solution to the challenging issue of software modifications.
“The speed of software updates makes calls for consideration important to ensure updates are timely and agency oversight remains effective,” said Horne. “While we want to ensure that updates do not pose a risk to patient safety, requiring a full review means necessary software updates could be stalled for months. In the past year, FDA has made great strides to modernize its approach to software products overall, and this is another step in the right direction.”
Similarly, Bradley Merrill Thompson, an attorney at Washington-based law firm Epstein Becker Green who counsels medical device companies on regulatory issues, applauded Shuren for his creativity.
“I rather like his idea. What he’s really saying is that he might consider focusing on capabilities in an effort to alleviate micromanagement,” said Thompson.
“I gather his idea is something along the lines of a company achieving a certification of competence to do certain validation testing or other quality assurance tasks, as a way to reduce the number of submissions for modifications,” he said. “That’s actually a very clever thought. It is consistent overall with the notion that the Good Manufacturing Practices assure that manufacturers are doing a certain amount of testing, and that so long as manufacturers are generally found to be in compliance with the GMPs, not every change requires FDA review. This simply takes that up a level.”
Federal law requires manufacturers to submit a new 510(k) premarket notification when changes or modifications made to an existing medical device could significantly affect its safety or effectiveness or the manufacturer makes a major change or modification in the intended use of the device.
Last month, the FDA issued draft guidance to industry to help them decide whether to submit a 510(k) for a software change to an existing device.
According to the agency, software modifications can take several forms, including: modification of software to keep it usable in a changed or changing environment; reactive modification of software to address discovered faults; and modification of software to improve performance or maintainability.
At a policy level, Thompson argues that one of the difficult challenges for the FDA in writing guidance on when a 510(k) is required for modifications is that it often has the unintended consequence of discouraging product improvements.
“For years, medical device manufacturers have struggled with this because if FDA makes it burdensome to make even small improvements to medical devices, companies tend to shy away from making those improvements,” he added.
“This issue will continue to be a priority for HITN going into 2017,” concluded Horne. “We look forward to partnering with the FDA and Congress on next steps to achieve the shared goal of clarifying the regulatory pathway for software products to ensure its effectiveness.”
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