This guidance document provides a detailed description of the information that should be included in a premarket notification for a magnetic resonance diagnostic device (MRDD). This document is a recommendation of how to comply with certain requirements contained in 21 CFR 807.87 and is intended to be used in conjunction with information regarding the content and format of a 510(k) premarket notification. For more information about the content and format of a 510(k), see FDA’s guidance entitled “Format for Traditional and Abbreviated 510(k)s” (http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocument s/UCM084396.pdf) and FDA’s guidance entitled, “Refuse to Accept Policy for 510(k)s” (http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/uc m315014.pdf). The approach outlined in this guidance document is intended to facilitate the timely review and marketing clearance of MRDDs.
MRDDs are also electronic products under section 531(2) of Subchapter C (Electronic Product Radiation Control (EPRC)) of the Federal Food, Drug and Cosmetic Act (FD&C Act). As such, MRDDs are subject to the radiological health requirements in Title 21, Subchapter J, Parts 1000 through 1050 of the Code of Federal Regulations, including applicability of general and specific performance standards (21 CFR Parts 1010-1050) and other general requirements for reporting and recordkeeping (21 CFR Part 1002), notification and corrective actions for defective or non-compliant electronic products (21 CFR Parts 1003 and 1004), and importation (21 CFR Part 1005).
This updated guidance document reflects advances in technology, regulatory decisions made by the Agency, updates to standards, and legislative changes adopted by the Agency since the issuance of the previous version of this document.
Posted on the FDA website on 18 November 2016