The FD&C Act, as amended by MDUFA V, authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. 61075, Beltsville, MD 20705-4304, 30, and the User Fees Support Staff End Further Info End Preamble Start Supplemental Information SUPPLEMENTARY INFORMATION: I. Robert Marcarelli, Office of Financial Management, Food and Drug Administration, 4041 Powder Mill Rd, Rm. Start Further Info FOR FURTHER INFORMATION CONTACT:įor information on Medical Device User Fees: industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa.įor questions related to the MDUFA Small Business Program, please visit the Center for Devices and Radiological Health's website: medical-devices/premarket-submissions/reduced-medical-device-user-fees-small-business-determination-sbd-program. This notice establishes the fee rates for FY 2023, which apply from October 1, 2022, through September 30, 2023, and provides information on how the fees for FY 2023 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Medical Device User Fee Amendments of 2022 (MDUFA V), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2023. Annual Establishment Registration Feeįood and Drug Administration, HHS. Premarket Notification Submission Fee Reduction Premarket Approval Fee Reduction or Waiver Small Business Fee Reductions and Fee Waivers Complete the Information Online To Update Your Establishment's Annual Registration for FY 2023, or To Register a New Establishment for FY 2023 Submit a DFUF Order With a PIN From FDA Before Registering or Submitting Payment Procedures for Paying Annual Establishment Registration Fees Procedures for Paying the Annual Fee for Periodic Reporting Submit Your Application to FDA With a Copy of the Completed Medical Device User Fee Cover Sheet Submit Payment for the Completed Medical Device User Fee Cover Sheet Electronically Transmit a Copy of the Printed Cover Sheet With the PIN Secure a Payment Identification Number (PIN) and Medical Device User Fee Cover Sheet From FDA Before Submitting Either the Application or the Payment How To Qualify as a Small Business for Purposes of Medical Device Fees MDUFA V Adjustments Solely to Registration Fees Further Adjustments To Generate the Inflation-Adjusted Total Revenue Amount Adjustments to Base Fee Amounts for FY 2023 This repetition of headings to form internal navigation links Headings within the legal text of Federal Register documents. This table of contents is a navigational tool, processed from the Provide legal notice to the public or judicial notice to the courts. Rendition of the daily Federal Register on does not Until the ACFR grants it official status, the XML Legal research should verify their results against an official edition of The official SGML-based PDF version on, those relying on it for The material on is accurately displayed, consistent with While every effort has been made to ensure that Regulatory information on with the objective ofĮstablishing the XML-based Federal Register as an ACFR-sanctioned The OFR/GPO partnership is committed to presenting accurate and reliable Register (ACFR) issues a regulation granting it official legal status.įor complete information about, and access to, our official publications Informational resource until the Administrative Committee of the Federal This prototype edition of theĭaily Federal Register on will remain an unofficial Each document posted on the site includes a link to theĬorresponding official PDF file on. The documents posted on this site are XML renditions of published Federal Register, and does not replace the official print version or the official It is not an official legal edition of the Federal This site displays a prototype of a “Web 2.0” version of the dailyįederal Register.
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