New draft guidance proposes a shift in how the FDA will evaluate certain device modifications

On September 28, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance document, entitled "The Special 510(k) Program," which, when finalized, will supersede the currently in effect Special 510(k) policy outlined in "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence" (March 20, 1998).

The modified policy described in this draft guidance is largely consistent with the core principles upon which the Special 510(k) pathway was created, but introduces a different, more expansive standard for assessing which devices are eligible for review under the program. The modified standard may enable device manufacturers to obtain a faster and less burdensome review for a broader scope of device modifications. The FDA has also launched a pilot program to evaluate the impact of the proposed updates to the framework, in which all Special 510(k) notices received on or after October 1, 2018 will automatically be included.

Read More: New draft guidance proposes a shift in how the FDA will evaluate certain device modifications


Download PDF Share Back To Listing
Loading data