FDA commends the signing of the FDA Reauthorization Act of 2017


On August 22, 2017, President Donald J. Trump signed the FDA Reauthorization Act of 2017 (FDARA) reauthorizing and updating the Medical Device User Fee Amendments (MDUFA) for the third time since it was established in 1992, allowing the US Food and Drug Administration (FDA) to continue to collect medical product user fees through fiscal year 2022. US Food and Drug Administration (FDA) officials commended the signing of the FDARA as it outlined many beneficial provisions that enhance approval pathways, streamline reviews for patient access, and increase oversight of patient safety. Additionally, the act enhances the Agency’s resources, better equipping FDA to advance and protect the public health.

The FDA unveiled the updated fiscal year (FY) 2018 amendment (MDUFA IV) on August 28, 2017, with effective dates from October 1, 2017 through September 30, 2018. In comparing FY18 user fees with those of FY2017 (see below), most standard applications saw an increase of approximately 32.5%. The 510(k) and de novo application categories were impacted the greatest: Standard 510(k) application fees were increased just over a 125% from $4,960 to $10,566, while a standard user fee of $93,229 was established for de novo submissions that were previously no cost to the applicant.

Small businesses with an approved small business designation (SBD) saw the same 32.5% increase in many user fee categories as standard applicants, but were spared a large hike in 510(k) fees at only 12.7% from $2,345 to $2,642.  A de novo user fee was also established for small businesses at $23,307.

The addition of a substantial user fee for de novo submissions is reflective of the Agency resources required to manage the review of these filings.  However, implementation of these fees may significantly affect the ability of small and start-up companies to commercialize novel technologies at a time when FDA is looking to this pathway to allow low and moderate risk technologies with no clear predicates (including many digital health products) to get to market.

Note that establishment registration fees, which increased approximately 37% (from $3,382 to $4,624), are the same for both standard and small businesses.

Sponsors who may qualify for a SBD must obtain their designation prior to any submission that is subject to user fees. The FDA has a 60-day review cycle for SBD applications, so this time should be considered when developing submission timelines. On August 29, 2017, the FDA released an updated Guidance for Industry, Food and Drug Administration Staff, and Foreign Governments entitled, “FY 2018 Medical Device User Fee Small Business Qualification and Certification.” The updated guidance - which went into effect on September 30, 2017 - supersedes the FY 2017 guidance, providing businesses with a pathway to apply for reduced fees should the Agency determine that they are qualified.

Application Type FY17 Standard Fee NEW FY18 Standard Fee FY17 – Approved SBD Small Business Fee  NEW FY18 - Approved SBD Small Business Fee
510(k) – Traditional, Abbreviated, and Special  $4,690 $10,566 $2,345 $2,642
513(g)  $3,166 $4,195 $1,583 $2,098
De Novo Classification  No Fee $93,229 No Fee  $23,307
Premarket Application (PMA), Product Development Protocol (PDP), Premarket Report (PMR), Biologics Licensing Application (BLA) $234,495 $310,764 $58,624 $77, 691
Panel-Track Supplement  $175,871 $233, 073  $43,968 $58, 268
180-Day Supplement  $35,174 $46, 615 $8,794 $11, 654
Real-Time Supplement  $16,415 $21, 753 $4,104 $5,438
BLA Efficacy Supplement  $234,495 $310, 764 $58,624 $77, 691
PMA Annual Report $8,207 $10, 877 $2,052 $2,719
30-Day Notice  $3,752 $4,972 $1,876 $2, 486
Annual Establishment Registration  $3,382 $4,624 $3,845 $4, 624
       

If you require assistance in understanding the guidance and how it will impact your business, contact ICON at www.iconplc.com/devices for more information.

Ashleigh Dawley,
Regulatory Affairs Specialist
Medical Device and Diagnostic Research, ICON plc 

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