**Introduction **
FDA has developed this draft guidance to propose select updates to the FDA guidance document, “Medical Device User Fee Small Business Qualification and Certification” (“Small Business Guidance”). The existing Small Business Guidance remains, in its current form, the Agency’s current thinking on the topic until this draft guidance is finalized. FDA intends to incorporate this draft guidance into one final guidance document, after obtaining and considering public comment on these select updates. The proposed sections referenced below are intended to enhance applicable sections of the existing Small Business Guidance. The sections of the existing Small Business Guidance that are not affected by this select update will not be substantively changed and will remain the Agency’s current thinking on the topic.
On December 29, 2022, the Food and Drug Omnibus Reform Act of 2022 (“FDORA”) was signed into law as part of the Consolidated Appropriations Act, 2023, Pub. L. No. 117-328. Section 3309 of the Omnibus “Small Business Fee Waiver” amends section 738(a)(3)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to give FDA discretion, beginning in fiscal year (FY) 2025, to waive the establishment registration fee for device establishments that are mall businesses, if FDA determines that paying such fee represents a financial hardship.
Based on this amendment, FDA is proposing updates to the guidance that describe how small businesses can show financial hardship to qualify for a small business registration fee waiver. For purposes of this new fee waiver provision, small business is defined as those that reported $1,000,000 or less of gross receipts or sales in their most recent Federal income tax return.
Additionally, FDA is proposing updating the guidance to reflect how applicants based in jurisdictions without a National Taxing Authority (NTA) need not submit a certification from an NTA to be eligible for fee waivers or reductions.
FDA’s guidance documents, including this draft guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic, and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.
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