Calendaring, Manufacturing and Small Business

Discounts Available! Submit a Small Business Certification Request Today for a Reduced Medical Device User Fee

FDA Law Blog

NOVEMBER 15, 2022

By Véronique Li, Senior Medical Device Regulation Expert & Philip Won — In our last blog post , we advised medical device companies to consider applying to FDA’s Small Business Program to help with the noticeably higher user fees for FY2023. In this blog post, we provide a primer on user fees and the Small Business Program.

Small Business

Small Business Calendaring Manufacturing Government

Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight

FDA Law Blog

JULY 7, 2024

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.

Manufacturing

Manufacturing Education Small Business Calendaring

Paralegal Brief

Discounts Available! Submit a Small Business Certification Request Today for a Reduced Medical Device User Fee

Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight

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