Megan Robertson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in MedTech Dive, in “5 Tips for Building a Predetermined Change Control Plan,” by Elise Reuter.
Following is an excerpt:
As more medical devices incorporate artificial intelligence, regulators are finding ways to handle frequent software updates.
One new framework is pre-determined change control plans, where companies can pre-specify what changes they intend to make to devices once on the market. This is a departure from the norm, where companies typically have to file a submission with the Food and Drug Administration for changes that could affect a device’s safety or effectiveness. The FDA has already authorized PCCPs after a 2023 draft guidance and issued final guidance clarifying its expectations in December.
In interviews with MedTech Dive, experts said PCCPs could be a bridge to more automated software updates. However, many manufacturers still have not used them, either because they aren’t comfortable with the framework or haven’t planned far enough ahead for their products.
Here are five tips on navigating PCCPs: …
Megan Robertson, an attorney at Epstein Becker Green, also expects PCCPs are here to stay.
“Given that the whole point of the PCCPs is to make things easier for developers,” Robertson said, “I would be surprised if the new administration severely pulled back on PCCPs or somehow limited the use of PCCPs.”
Is a PCCP the right approach? …
Companies must remember several factors when considering a PCCP. The FDA specifies that changes must be necessary to maintain or improve a product’s safety and effectiveness, and the updates can’t change the intended use of a device. Companies also have to submit a modification protocol to the FDA and follow that same procedure every time, Robertson said.
The framework makes sense for devices where routine changes or modifications would be required, such as calibrating with new operating systems, Robertson said.
“Based on the nature of AI,” Robertson added, “it should be a discussion for most, if not all AI- or ML-enabled device functions.”
