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NEWS & BLOGS
Blog: Blog2
FDA, New Medical Device User Fees for FY 2026
On July 30, 2025, the U.S. FDA announced the Medical Device User Fees applicable for Fiscal Year 2026 (October 1, 2025 – September 30,...
Provision Consulting Group
Aug 12 min read
New FDA Import Rules Eliminate $800 De Minimis Exemption
What the End of the “De Minimis” Rule Means for FDA-Regulated Imports As of July 2025, the U.S. FDA has officially eliminated the...
Provision Consulting Group
Jul 282 min read
Top 5 Cosmetic Labeling Mistakes to Avoid After MoCRA Compliance
5 Common Cosmetic Labeling Mistakes Revealed by FDA Warning Letters As K-Beauty continues its surge in popularity in the U.S. cosmetic...
Provision Consulting Group
Jul 233 min read
Responsibilities of an FDA Initial Importer
February 4, 2025 Responsibilities of an FDA Initial Importer When importing medical devices into the United States, manufacturers must...
Provision Consulting Group
Feb 42 min read
Everything You Need to Know About FDA Establishment Registration for Medical, Drug, and Cosmetic Products
November 27, 2024 Navigating FDA regulations can be complex, but understanding and fulfilling your FDA Establishment Registration...
Provision Consulting Group
Nov 27, 20242 min read
Navigating the FDA’s Guidance on Orthopedic Non-Spinal Bone Plates, Screws, and Washers
November 25, 2024 The FDA’s recently issued guidance on orthopedic non-spinal bone plates, screws, and washers outlines crucial updates...
Provision Consulting Group
Nov 25, 20242 min read
Why Your Business Needs an Initial Importer: Key Benefits for FDA Compliance
November 13, 2024 Expanding a product line into the U.S. market is a major milestone, especially in FDA-regulated industries like...
Provision Consulting Group
Nov 13, 20244 min read
FDA’s Warning to Cosmetics: What Your Brand Needs to Know About Recent Compliance Trends
November 6, 2024 In an industry as competitive and fast-evolving as cosmetics, staying compliant with FDA regulations isn’t just...
Provision Consulting Group
Nov 6, 20242 min read
2025 FDA Compliance Essentials for K-Beauty Brands
November 4, 2024 Introduction As K-beauty brands continue to gain popularity in the U.S., navigating FDA regulations is crucial for...
Provision Consulting Group
Nov 4, 20243 min read
FDA Issues New 2024 Tattoo Ink Safety Guidelines: What Tattoo Artists and Consumers Need to Know
October 30, 2024 Introduction The tattoo industry has recently received a major update from the U.S. Food and Drug Administration (FDA)...
Provision Consulting Group
Oct 30, 20242 min read
Missed Your FDA Renewal? Here’s What’s at Stake
October 04, 2024 It’s that time of year again—the FDA renewal period is here! But what happens if you let that deadline slip? If you're...
Provision Consulting Group
Oct 4, 20242 min read
MoCRA: More Than Just Compliance, A Boost for the Cosmetics Industry
Date: 4/19/2024 The Modernization of Cosmetics Regulation Act (MoCRA) of 2022, implemented in December 2022, marks a significant shift in...
Provision Consulting Group
Apr 19, 20242 min read
Daewon Pharmaceutical Co., Ltd. Preparing for FDA Quality Management System (QMS) and cGMP Inspection with Provision Consulting Group
Date: 12/11/2023 Daewon Pharmaceutical Co., Ltd. Preparing for FDA Quality Management System (QMS) and cGMP Inspection with Provision...
Provision Consulting Group
Dec 11, 20232 min read
FDA Compliance & Amazon Success: Our Case Study in Rapid Regulatory Remediation
Date: 11/21/2023 Ensuring FDA Compliance and Resuming Sales: Provision Consulting Group's Expertise in Action in Amazon. Operating under...
Provision Consulting Group
Nov 21, 20232 min read
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