Ashleigh Dawley

Regulatory Affairs Specialist, Medical Device and Diagnostic Research

On December 26, 2017, the FDA’s Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research announced a proposed programme for publishing certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis, instead of filing each individual MDR within 30 days. The programme - referred to as the Voluntary Malfunction Summary Reporting Program for Manufacturers - is under a comment period until Feb. 26, 2018.

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.