Breakdown of FDA’s Medical Device User Fees

Premarket Notifications (510(k)s), Premarket Approval Applications (PMAs), Premarket Reports (PMRs), notices, and supplements all have associated fees to be paid to the FDA before they will review a medical device product. The 2019 Medical Device User Fee Amendments (MDUFA) are listed at 2019 MDUFA. If the FDA determines that a manufacturer is a “small business” (the manufacturer applies to the FDA for that qualification and represents that the business reported $100 million or less in gross receipts or sales in the most recent federal income taxable year), the manufacturer may qualify for a reduced fee which is 50% of the standard fee.

  • 513(g) Requests for Information are subject to a user fee, according to Section 738(a)(2)(A)(ix) of the FD&C Act. There are no exceptions to the fee requirement for 513(g) requests. Paying the user fee for a 513(g) request does not waive any subsequent fees for a new submission type. Additionally, the only time the FDA may issue a refund is if the FDA determines that a submission is not actually a 513(g) request.
  • De Novo Requests may be subject to user fees, unless the request falls under an exception, according to Section 738(a)(2)(A)(xi) of the FD&C Act.
    • Exceptions to user fees for De Novo Requests are available for
      • submissions for devices intended solely for a pediatric population, or
      • submissions submitted by state or federal government entities whose device will not be distributed commercially.
    • Fee amount: $96,644 standard; $24,161 small business
    • See User Fees and Refunds for De Novo Classification Requests for further guidance
  • 510(k) submissions may be subject to user fees, but there is greater opportunity to take advantage of the FDA’s Bundling Policy (see below).
    • Exceptions to fee requirements:
      • applications from a state or federal government entity shall be exempt unless the device is to be distributed commercially
      • applications for a device intended solely for pediatric use shall be exempt
    • Fee amount: $10,953 standard; $2,738 small business
    • See User Fees and Refunds for Premarket Notification Submissions (510(k)s) for further guidance
  • PMAs & BLAs have the most expensive user fees. Panel-track supplements, 180-day supplements, real-time supplements, BLA efficacy supplements, Annual Reports, and 30-day Notices have their own lesser costs to be paid at the time of their separate submission. However, the following PMA supplements are not subject to user fees: Special PMA supplement, PMA supplement for manufacturing/sterilization site change, PMA supplement for trade name change, PMA supplement for post approval study protocol, and PMA post approval study labeling update. And, the following BLA supplements are not subject to user fees: Prior Approval Supplements that are not efficacy supplements, Changes Being Effected in 30 days, Changes Being Effected, and Annual Reports.
    • Exceptions to User Fees:
      • Section 738(a)(2)(B)(v)(I) of the FD&C Act provides an exemption of the user fee for any PMA or BLA that is intended solely for a pediatric population.
      • Section 738(d)(1) of the FD&C Act allows a one-time waiver of the user fee for a small business submitting their first ever original PMA or BLA.
      • Section 738(a)(2)(B)(ii) of the FD&C Act provides that “A BLA submitted under section 351 of the Public Health Service Act for a product licensed for further manufacturing use only is exempt from user fees.”
      • Section 738(a)(2)(B)(iii) of the FD&C Act provides an “exception from user fees for a PMA or BLA submitted by a state or federal government entity ‘unless the device involved is to be distributed commercially.’”
    • Fee amount: $322,147 standard; $80,537 small business
    • See User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications for further guidance

FDA’s Bundling Policy – Bundling within a single premarket submission only requires one user fee. FDA may consider bundling multiple devices in a single submission when multiple devices or indications for use presented issues that could be addressed during one review. “In determining whether it can review a bundled submission during the course of one review, FDA may consider whether: (i) the supporting data are similar; (ii) primarily one review division/group will be involved; and (iii) the devices or indications for use are similar.” Bundling of multiple devices may be done for 510(k)s and PMAs.

  • 510(k)s – Bundling devices in a single 510(k) submission may be appropriate if the devices are used together during a therapeutic or diagnostic procedure, or if one device is an accessory to another.
  • PMAs & BLAS – Although bundling is sometimes allowed (e.g., if the clinical data is the same for multiple indications), it is not advisable to bundle differing generic device types in a single PMA submission because of the “substantially different pre-clinical and clinical data needed to support each of the devices.”
  • See Bundling Multiple Devices or Multiple Indications in a Single Submission for further FAQs

Submitting user fees to the FDA: Complete the MDUFA Cover Sheet (Form FDA-3601) if required, then send payment with the completed cover sheet and completed application. The FDA provides a helpful overview at: https://www.fda.gov/medical-devices/premarket-submissions/medical-device-user-fees.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

Email office@softwarecpr.com
for more info!

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.