Alcohol, Tobacco, Firearms, and Explosives Bureau August 19, 2015 – Federal Register Recent Federal Regulation Documents
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Center for Devices and Radiological Health Participation in International Medical Device Regulators Forum, Regulated Product Submission, Table of Contents Pilot Program
The Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH), Offices of Device Evaluation (ODE) and In Vitro Diagnostics and Radiation (OIR) are announcing their participation in the International Medical Device Regulators Forum's (IMDRF) Regulated Product Submission Table of Contents Pilot Program. Participation in the Pilot is voluntary and open to applicants who submit premarket approval (PMA) applications or premarket notification (510(k)) to either ODE or OIR. The Pilot project is intended to provide industry, IMDRF, and CDRH staff the opportunity to evaluate the Table of Contents structure and to receive input from industry participants. Participants will be asked to submit their submissions electronically using IMDRF's Table of Contents (ToC) format.
Medical Devices; Export Certificates; Food and Drug Administration Export Reform and Enhancement Act of 1996; Certification Fees
The Food and Drug Administration (FDA) is announcing the revised fees the Agency will assess for issuing export certificates for devices. The FDA Export Reform and Enhancement Act of 1996 (EREA) provides that any person who exports a device may request FDA certify in writing that the exported device meets certain specified requirements. It further provides that FDA shall issue such a certification within 20 days of the receipt of a request for such certification and that FDA may charge up to $175 for each certification that is issued within the 20 days. Since February 2003, FDA's costs to process the device certificates have increased; however, the export certificate fee for subsequent certificates has not changed. Because of the increase, FDA is raising the fees for subsequent certificates, from the current fee of $15 to $85, and revising the formula used to calculate the number of original and subsequent device export certificates issued. These changes are necessary to ensure that the program remains self-sustaining and to cover FDA's increased costs, which are currently being covered by appropriated funds. Further, this document explains the costs associated with the export certification program for devices.
Obstetrics and Gynecology Device Panel of the Medical Device Advisory Committee; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of June 9, 2014 (79 FR 32964). Due to some recent confusion with the 2014 docket, this 2014 notice and all materials associated with it are being moved to a new docket. This document announces the new docket number.
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