New 510 Research Paper

The New 510(k) Paradigm Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications
Final Guidance This document is intended to provide guidance. It represents the Agency's current thinking on the above. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. Prepared by the Center for Devices and Radiological Health March 20, 1998

Comments and suggestions may be submitted at any time for Agency consideration to Heather Rosecrans, Office of Device Evaluation, 10903 New Hampshire Avenue, Silver Spring, MD 20993. Comments may not be…show more content…
These types of changes generally include modifications to the device's operating principle(s) or mechanism of action, such as automation of a manual device or incorporation of a sensing or feedback circuit. Specific examples that illustrate these types of changes that alter the fundamental scientific technology and thus should not be submitted as Special 510(k)s include: 1. A change in a surgical instrument that uses a sharpened metal blade to one that cuts with at a laser; A change in an in vitro diagnostic (IVD) device that uses immunoassay technology to one that uses nucleic acid hybridization or amplification technology; Incorporation of a sensing mechanism in a device to allow the device to function "on demand" rather than…show more content…
Clinical Considerations
FDA recognizes that clinical evaluation may be involved in the validation of the design of a modified device. Manufacturers are reminded that all clinical investigations must conform to the applicable regulations, including 21 CFR Parts 812, 50 and 56. Therefore, collection of clinical data to support a Special 510(k) may require submission of an investigational device exemptions (IDE) application to FDA. The fact that a significant risk device investigation was conducted to support any of the activities listed above, however, does not necessarily preclude the submission of a Special 510(k). 7

Manufacturers who intend to conduct clinical investigations of a modified device as part of design validation are encouraged to contact the appropriate ODE review division before preparing a Special 510(k). When a clinical investigation is necessary to answer safety and effectiveness questions relating to a particular modification, the Agency believes that the modification is likely to have gone beyond that which is suitable for review as a Special 510(k). In contrast, where design validation involves clinical evaluation intended to ensure that the modified device meets user requirements as opposed to patient safety and effectiveness or to demonstrate continued conformance with a special control or recognized standard, FDA believes that the Special 510(k) may be the appropriate