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The Medical Device User Fee Small Business Qualification and Determination program is a fee reduction program from the FDA that allows qualifying small businesses to receive reduced or waived user fees when submitting medical device applications.
Small businesses with gross sales or receipts not exceeding $100 million may qualify for reduced premarket submission fees, which can represent substantial savings for early-stage device companies. As of November 1, 2024, all Small Business Requests must be submitted through the updated process outlined in FDA's guidance documents.
The program helps lower the financial barrier for small businesses seeking FDA approval for medical devices.
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Medical Device User Fee Small Business Qualification and Determination | FDA Skip to in this section menu Medical Device User Fee Small Business Qualification and Determination Center for Devices and Radiological Health Center for Biologics Evaluation and Research This final guidance updates the previous version of the guidance, titled “Medical Device User Fee Small Business Qualification and Certification; Guidance for Industry, Food and Drug Administration Staff and Foreign Governments,” issued on August 1, 2018.
The guidance includes updates that describe how FDA will determine if a small business is experiencing "financial hardship," which would make the business eligible for a waiver of their registration fee (“Small Business Registration Fee Waiver”).
The guidance details the types of information an entity seeking the waiver may submit for FDA’s consideration in determining whether to grant the Small Business Registration Fee Waiver, including entities that are in jurisdictions without a national taxing authority. The guidance is also being updated to reflect the planned replacement of Forms 3602 and 3602A with a single combined form (Form 3602N).
You can submit online or written comments on any guidance at any time (see 21 CFR 10. 115(g)(5)) If unable to submit comments online, please mail written comments to: Food and Drug Administration 5630 Fishers Lane, Rm 1061 All written comments should be identified with this document's docket number: FDA-2018-D-1873 .
Based on current listing details, eligibility includes: Small businesses with gross sales or receipts not exceeding $100 million. Applicants should confirm final requirements in the official notice before submission.
Current published award information indicates Varies Always verify allowable costs, matching requirements, and funding caps directly in the sponsor documentation.
The current target date is rolling deadlines or periodic funding windows. Build your timeline backwards from this date to cover registrations, approvals, attachments, and final submission checks.
Federal grant success rates typically range from 10-30%, varying by agency and program. Build a strong proposal with clear objectives, measurable outcomes, and a well-justified budget to improve your chances.
Requirements vary by sponsor, but typically include a project narrative, budget justification, organizational capability statement, and key personnel CVs. Check the official notice for the complete list of required attachments.
Yes — AI tools like Granted can help research funders, draft proposal sections, and check compliance. However, always review and customize AI-generated content to reflect your organization's unique strengths and the specific requirements of the solicitation.
Review timelines vary by funder. Federal agencies typically take 3-6 months from submission to award notification. Foundation grants may be faster, often 1-3 months. Check the program's timeline in the official solicitation for specific dates.
Many federal programs offer multi-year funding or allow competitive renewals. Check the official solicitation for continuation and renewal policies. Non-competing continuation applications are common for multi-year awards.
IFDA Philadelphia Scholarship is a scholarship from the IFDA Educational Foundation, supported by the IFDA Philadelphia Chapter, that awards $2,500 to a full-time current undergraduate student enrolled in an interior design or related program. The scholarship is administered by the IFDA Educational Foundation, a 501(c)(3) nonprofit dedicated to supporting the home furnishings and design community through educational funding. Eligible applicants are full-time undergraduate students supported by the Philadelphia Chapter. The deadline for the current cycle was March 31, 2026.
PAR-24-251: Animal and Veterinary Innovation Centers (U18) is sponsored by Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM). The FDA's Center for Veterinary Medicine (CVM) is seeking applications for Animal and Veterinary Innovation Centers (AVICs) to address critical unmet needs impacting animal and human health. These cooperative agreements will establish long-term partnerships with academic research institutions to advance regulatory science and the development of innovative animal products, focusing on areas like Highly Pathogenic Avian Influenza (HPAI), intentional genomic alterations in animals, and unmet veterinary medical needs in minor and major species.
-Purpose. This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose to develop, standardize, and validate new and innovative assays, integrated strategies, or batteries of assays that determine or predict specific organ toxicities (e.g., ocular, dermal, hematotoxicity, cardiotoxicity, gastrointestinal toxicity, hepatotoxicity, nephrotoxicity, ototoxicity, olfactory loss, bladder toxicity, neurotoxicity, pulmonary toxicity, endocrine toxicity, and pancreatic beta cell toxicity), resulting from both acute and chronic exposures to various chemicals, environmental pollutants, biologics and therapeutic molecules or drugs. In addition, this FOA encourages the development, standardization, and validation of new models of arthritis, convulsion, infection and shock. New approaches for high throughput toxicity screening that involves the use of molecular endpoints, computer modeling, proteomics, genomics and epigenomics and the development of virtual tissues are also encouraged as are development of 3-dimensional organ models for toxicity evaluation. -Mechanism of Support. This FOA will utilize the SBIR (R43/R44) grant mechanisms for Phase I, Phase II, and Fast-Track applications and runs in parallel with a FOA of identical scientific scope, PA-09-007, which encourages applications under the Small Business Technology Transfer (STTR) (R41/R42) grant mechanisms. Funding Opportunity Number: PA-09-006. Assistance Listing: 93.113,93.173,93.361,93.389,93.837,93.846,93.847,93.848,93.849,93.859,93.867. Funding Instrument: G. Category: ED,ENV,FN,HL.
Purpose. This Funding Opportunity Announcement (FOA), issued by the National Cancer Institute (NCI), National Institutes of Health (NIH), invites Small Business Innovation Research (SBIR) cooperative agreement applications from small business concerns (SBCs) that propose to develop new, or to improve existing application(s) of nanotechnology-based therapeutics or/and in vivo diagnostics. This FOA will specifically support pre-clinical optimization and testing of these cancer-relevant nanotechnology applications against the intended cancer type. The proposed projects must be milestone-driven and must be clearly directed toward development of an ultimate commercial product. The outcomes are expected to advance the discovery and pre-clinical optimization phase so that an Investigational New Drug (IND) or Investigational Device Exemptions (IDE) application could be submitted to the Food and Drug Administration (FDA) by the end or shortly after completion of the Phase II project period. To facilitate these steps, the NCI will assist the awardees in various ways, including the support through the NCI-sponsored Nanotechnology Characterization Laboratory. This FOA will NOT support basic research projects, studies on disease mechanisms, and clinical trials. Mechanism of Support. This FOA will utilize the SBIR (U43/U44) cooperative agreement mechanisms for Phase I and Phase II applications. Funds Available and Anticipated Number of Awards. Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. The total amount awarded and the number of awards will depend upon the quality, duration, and costs of the applications received. Funding Opportunity Number: PAR-10-286. Assistance Listing: 93.393,93.394,93.395,93.396. Funding Instrument: CA. Category: ED,HL. Award Amount: Up to $150K per award.
This Funding Opportunity Announcement (FOA) invites Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) for funding to perform research leading to the development of innovative technologies that may advance progress for early detection and assessment of individuals at risk and for early diagnosis, prognosis and follow-up of type 1 diabetes (T1D). Funding Opportunity Number: RFA-DK-15-024. Assistance Listing: 93.847. Funding Instrument: G. Category: FN,HL. Award Amount: $2M total program funding.