What does a device manufacturer do when it wants to make changes to its products? Before now, that was unclear; but, the FDA issued a draft guidance that aims to clear the confusion.
The draft guidance addresses when device manufacturers and/or software developers must receive regulatory approval before making changes to their products. Because the approval process is a long and arduous one, the FDA has clarified when and what type of approval process should be used.
The FDA states that any changes to the overall structure of a device’s software should be resubmitted to the agency through the 510(k) process. This processes is designed to rely on clinical trial data of similar devices for approval, thus saving time and money for new devices.
More substantial changes to a device’s software will require a lengthy approval process. Devices undergoing a change in the core algorithm will have to go through a completely new approval process.
But not every change will require an FDA approval. The agency will allow most changes to strengthen the cybersecurity of devices without a formal approval process. Manufacturers can also change the appearance of their devices without requesting approval as long as the changes don’t affect the clinical use of the device.
The FDA is busy flexing its regulatory muscles with other draft guidances regarding 3D printed medical devices, conflicts of interests on advisory panels, and tobacco products. The FDA’s new authority over tobacco products like e-cigarettes took effect earlier this week and has already attracted both criticism and praise.
The FDA is making a clear effort to shape up, but the agency has a while to go. The FDA has received harsh criticism for being slow to recall contaminated food products like General Mills flour. While change is usually a slow process, critics are hoping the FDA can make more progress in protecting consumers from dangerous products.