New Draft Guidance for The Special 510(k) Program
Today the FDA released a DRAFT guidance for The Special 510(k) Program. The draft is an update to the current Special 510(k) guidance policy in “The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial 28 Equivalence in Premarket Notifications,” that has been available since March 20, 1998.
The Special 510(k) review process is in place to allow manufacturers a faster review and clearance of a device that uses their own existing device that is currently cleared for commercial distribution as the predicate. The FDA relies heavily on the information that was submitted in the manufacturer’s predicate device submission wants the manufacturer to include a statement in the Special 510(k) affirming they are the manufacturer of the predicate device.
The FDA hopes the DRAFT guidance provide some clarity on and expand the current policy regarding the types of changes that are eligible for the Special 510(k) 30-day review program. The main updates focus on the indications for use and the technological changes that can be considered a Special 510(k).
The guidance explains that the FDA wants to see “rigorous design control procedures” that will allow manufacturers to develop the foundation for a solid Substantial Equivalence (SE) determination that is still within the principles of SE. This highlights the importance of solid and robust verification and validation procedures that ensure design outputs meet the design inputs.
Manufacturers should continue to rely on any device specific guidance documents, special controls or other standards that are applicable to the product or technology. All information regarding the changes to the device should be able to be summarized in a way to support SE (i.e. V&V summaries or labeling change summaries). If the information can’t be summarized, then the FDA may reject the Special 510(k) 30-day review submission and require a Traditional 510(k) review and that increases the review time to 90 days.
If you have any questions about the Special 510(k) review process or are not sure what 510(k) path your device should follow contact O’Connell & Myers. This is in our wheel house so let us guide you.