💰FDA Final Guidance on Medical Device User Fees for Small Businesses
Medical Device User Fee Small Business Qualification and Determination Guidance Final Guidance for Industry and Food and Drug Administration Staff and Foreign Governments; Availability
Summary
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Medical Device User Fee Small Business Qualification and Determination Guidance." This guidance updates the previous version of the guidance, titled "Medical Device User Fee Small Business Qualification and Certification Guidance", issued on August 1, 2018. The guidance includes updates which describe how FDA plans to determine if a small business is experiencing "financial hardship" which makes them eligible for a waiver of their registration fee. The guidance details what information FDA intends to review and consider in making this determination.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The announcement of the guidance provides financial assistance through fee waivers for small businesses that can demonstrate financial hardship, which directly impacts business owners in the medical device sector. It clarifies the process for qualification and eligibility for fee waivers, thus informing businesses of potential cost relief.