As posted in the Federal Register, the Food and Drug Administration (FDA) seems to be considering a policy that would make it easier for companies to get medical devices reviewed and approved. If their new policy to be passed, it would lead require all submitting devices to be approved by separating them into different categories, among other measures taken for protection.
To accomplish this, the text of the proposal would alter the existing definitions of the different "classes" of devices. One of the problems with current device class definitions, according to this proposal, is that they don't account for the specific circumstances the devices will be used under.
This includes identifying the kinds of risks that go hand in hand with each device, and the proposal notes that these can range from known risks to those that aren't known or that are thought to be "favorable."
Figuring out where different devices rank in the overall scheme of healthcare IT is obviously necessary for using them effectively, and regulatory compliance consulting can help with ascertaining proper use in this area. As Dr. Andrew Litt recently wrote for ComputerWorld, mobile applications might pose a problem for those not sure if they should be classified as a device unto themselves.
"It is critical that, in the end, a regulatory balance is found to allow innovations to improve health while maintaining patient safety protections," Litt writes.
Because applications may take different forms and come with other plans and initiatives, your practice should turn to the regulatory compliance consultants that might help new devices get incorporated successfully.