Medical devices may have an easier time receiving FDA clearance following the administration's proposal to create fast track approval, according to Reuters.
Here are five things to know:
1. The new proposal would provide an alternate way companies could earn approval to market devices that do not meet the FDA's current fast track route, the 510(k) pathway.
2. To earn 501(k) clearance, medical devices must be of moderate risk and equivalent to existing devices. High-risk devices require additional review. However, some argue with the emergence of new technology it is hard for medical devices to identify a predicate.
3. FDA officials proposed eliminating the need for a predicate in order for a device to receive clearance and offered the option of using a benchmark consisting of performance standards or guidance documents. The new pathway would be voluntary to companies.
4. The FDA also plans to reevaluate the amount of safety data high risk devices need prior to approval. In a statement, the FDA said, "certain issues could be ultimately resolved in the post-marketing setting, rather than the pre-marketing setting, to allow patients to gain faster access to potentially life-saving devices."
5. While the proposal follows President Donald Trump's promises to eliminate regulations, others worry the simplified process could harm patients. Rita Redberg, MD, of UC San Francisco told Reuters the new guidelines "from the pre-approval to the post-market setting would turn patients into guinea pigs."