FDA issues new guidance on medical device user fee refunds and exceptions

FDA logo

The FDA issued new guidance this month detailing cases in which a medical device manufacturer may be eligible for a refund of the user fee paid for agency review.

The federal watchdog agency described user fee protocols for both 510k and premarket approval applications, laying out the general guidelines the FDA will follow in determining whether the applicant may be able to request a user fee refund.

The new guidance fits with the FDA’s new Medical Device User Fee & Modernization Act, which Congress authorized in June 2012 to bump up the user fees that medical device makers pay for agency review. The agency has since issued new guidances on 510(k) time-frames, PMA approval time lines, 510(k) pre-review sessions and more in efforts to streamline and clarify the medical device review pathway.

A pair of guidances issued this week aim to make clear the user fee exception and refund eligibility for various types of 510(k) and PMA applications.

In general, both types of review are eligible for the same types of exemptions – user fees need not be paid on medical device applications intended solely for a pediatric population or if the application is filed by a state or federal entity on a device that is not intended for commercial distribution.

Sponsors may be further exempt from 510(k) user fees if the application is considered eligible and undergoes review by an FDA-accredited 3rd party prior to submission to the FDA, and there is a 1-time PMA fee waiver for qualifying small businesses submitting their 1st application. PMA submissions for biologics intended solely for manufacturing use are also exempt from user fees, according to the PMA guidance.

The new PMA and 510(k) guidelines also share certain refund eligibility protocols, such as those for early application withdrawal. Sponsors can request a refund of an entire 510(k) user fee or 75% of a PMA application if the FDA hasn’t worked on it. If a 510(k) application has already been accepted for review, no refund will be issued for a withdrawal.

If the FDA has begun work on a PMA application, the agency may refund the user fee as long as the FDA hasn’t taken "1st action." The FDA defined 1st action as something akin to an approvable or non-approvable letter, and any refunds requested after that action has been taken would take into account the effort the FDA has already spent on the application, based generally on the number of days the application has been under review.

For both types of applications, the FDA will refund any user fees if the application is not accompanied by an acceptable electronic copy, which is now required of all medical device review applications. If none is provided or the eCopy filed is not up to the agency’s technical standards, the FDA will notify the sponsor and keep the application on file for 180 days to allow for a new submission. After that point the agency will delete the application from its system and refund the user fee.

The FDA also agreed to refund any users fees paid on an incomplete PMA or 510(k) application. The agency will conduct an initial review of each 510(k) or PMA application and determine whether the information provided is sufficient for review. If the application is incomplete, the sponsor can choose to withdraw the submission and request a refund of the user fees paid.

The PMA rules trickle down further for each type of PMA application, including 180-day supplements, panel-track supplements and 30-day notices. Read through the exception and refund criteria for each PMA type here, or for 510(k) submissions here.

RSS From Medical Design & Outsourcing

  • GlobTek presents its latest level VI AC/DC adapter and connverter
    T-43086-WWVV-X.X-Q Model is an addition to GlobTek’s Level VI compliant GT-43086 family and represents GlobTek’s 6 Watt wall plug-in series of AC/DC adapters (power supplies and chargers) with International Interchangeable blades. GlobTek’s changeable input blade system with individual field replaceable input plugs, including: North America and Japan NEMA 1-15P, Australian, UK BS 1363, European CEE […]
  • Sanmina’s familiarity with FDA gets skin treatment product to market fast
    The medical market for cosmetic devices is booming. However, quickly launching new products to meet demand is becoming more challenging because device manufactures face increased regulatory scrutiny. To help meet regulatory requirements, aesthetic and other medical-device OEMs are partnering with electronics manufacturing services (EMS) companies that also offer expertise with the FDA filings necessary to […]
  • Fluid connectors and quick disconnects for IVD equipment from CPC
    Colder Products Company (CPC) offers thousands of tubing connectors, quick disconnects and fittings for smart fluid handling in IVD and analytical equipment. Non-spill connectors speed testing throughput by eliminating drips, preventing air inclusion and increasing operator safety. Panel mount connectors can be added to existing equipment or bottle caps to provide secure, leak-free connections. Puncture […]
  • 310 Watt desktop medical power supply meets efficiency level VI requirements
    Power Partners releases a new 310 Watt medical grade desktop power supply from their PEAMD Series of AC and DC adapters. The 310 Watt unit is packed for ideal performance inside a compact case measuring 7.8 x 4 x 2 in. with a weight of only 3 lbs. The PEAMD310 Series is approved to the latest […]
  • Saelig introduces Multiple Instrument System MIS4 universal test system
    Saelig Company has introduced the ABI Electronics’ Multiple Instrument Station MIS4, an all-in-one testing tool that provides all commonly required test instruments in one compact programmable hardware module, mounted in a compact case or installed in a PC-drive bay. Controlled by ABI’s sophisticated SYSTEM 8 Ultimate PC software with a simple yet programmable operator interface, […]
  • AssurX announces document management software update for small to mid-size companies in FDA regulated industries
    AssurX, an enterprise quality management, risk and regulatory compliance solution provider, announces the release of the latest update to their AssurX document management software. The document management solution provides a cost-effective solution for small to medium sized companies faced with streamlined operations and is fully compliant for FDA regulated industries. Ideal solution for small to […]
  • Saelig presents new Amplicon Impact-R 1100F series computer
    Saelig Company announces the Amplicon Impact-R 1100F series, a fanless system powered by the Intel ATOM D2550 processor. Configured with a high performance 2.5 in. MLC Solid State Drive (SSD), the Impact-R 1100F series is a silent controller system. With options for multiple serial communication ports, the Impact-R 1100F can offer up seven DB9 connections […]
  • Gerresheimer to acquire Centor
    Gerresheimer AG, a partner to the global pharmacy and healthcare industry, will further extend its pharmaceutical packaging business with the acquisition of Centor. Gerresheimer has reached an agreement with Nemera Development S.A. to acquire 100% of the share capital of Centor US Holding. “Centor is the highly profitable market leader for plastic vials and closures in […]
  • Methods Machine Tools presents the new Nakamura-Tome NTRX-300
    Methods Machine Tools, a developer of precision machine tools and automation, has introduced the new Nakamura-Tome NTRX-300, a multitasking turning center featuring complete parts machining in one operation, with a built-in load and unload automation system and advanced operator recognition management software. The NTRX-300 features true opposing twin spindles: an 8 in. A2-6 25 HP or […]
  • MSC Apex Diamond Python and Smart Midsurface speeds modeling to validation
    MSC Software announced a new release of MSC Apex, the company’s award-winning next generation Computer Aided Engineering (CAE) platform. The MSC Apex Diamond Python release introduces: · The fourth release of MSC Apex Modeler is a CAE Specific direct modeling and meshing solution that streamlines CAD clean-up, simplification and meshing workflow. New in this release is […]
  • Quality Metrics: FDA’s plan for a key set of measurements to help ensure manufacturers are producing quality medications
    Editor’s Note: This article is written by Ashley Boam and Mary Malarkey from the “FDA Voice” blog. Boam is an FDA’s acting Director of the Office of Policy for Pharmaceutical Quality, the Office of Pharmaceutical Quality and the Center for Drug Evaluation and Research. Malarkey is an FDA’s Director if the Office of Compliance and Biologics Quality […]

Leave a Reply