At a public meeting on February 18, FDA said that when evaluating devices for 510(k) clearances, it is difficult to compare new products to those already approved, according to Reuters. Heather Rosecrans of FDA said that it may be necessary to develop clearer guidelines or add more authorities.

Chiming in with their own concerns, some device makers present at the meeting said that major reform to the 510(k) process could prevent newer technology from making it to market, said Reuters.

In a statement, industry group AdvaMed says, "While the basic structure of the 510(k) process works very well and has evolved over time to better meet the needs of American patients, we recognize that there is no process that cannot be improved."

According to Reuters, FDA will accept public comments for the next month before making its task force's recommendations public in June.