To better keep up with the speed of innovation in medical technology, FDA continues to identify and implement new ways to expedite clearance for medical devices. The agency has issued four final guidance documents related to the 510(k) clearance applications for medical devices. The Guidance documents can be found here, and they describe the FDA’s current thinking on special 510(k) clearance programs such as the Abbreviated application and the newly established “Special 510(k)” program.
The Abbreviated 510(k) Program uses guidance documents, special controls, and/or voluntary consensus standards to facilitate FDA’s premarket review of 510(k) submissions. The alternative approach described in this guidance document is intended to facilitate 510(k) submission preparation by manufacturers and review by FDA.
The intent of the Special 510(k) program is to offer an optional pathway for certain well-defined device modifications where a manufacturer modifies its own legally marketed device, and design control procedures produce reliable results that can form, in addition to other 510(k) content requirements, the basis for substantial equivalence (SE).
At the speed at which medical technologies are evolving in the marketplace, these expedited clearance pathways will help device manufacturers make the product improvements that they need to keep pace with market demands. The FDA has stated that it believes these programs may conserve industry and Agency resources, while still protecting the public health, and not altering the statutory criteria for substantial equivalence.
The other two final guidance documents issued by the FDA update the format for Traditional and Abbreviated 510(k) application formats, and provide technical assistance to industry and the agency on acceptance standards for 510(k) submissions.
If you are considering what FDA approval or clearance pathways are applicable to your products, contact us and we may be able to help.