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NEWS & BLOGS
Blog: Blog2
Dexcom G7 15-Day Receives FDA Clearance: What This Means for Diabetes Management
April 14, 2025 The FDA has cleared the Dexcom G7 15-Day Continuous Glucose Monitoring (CGM) System, marking a significant milestone in...
Provision Consulting Group
1 day ago2 min read
3
Don’t Let Mislabeling Cost You: What the FDA Coffee Recall Teaches Us About Compliance
April 11, 2025 In recent news, the FDA issued a recall for coffee grounds sold in 15 states after the product was misbranded as...
Provision Consulting Group
4 days ago3 min read
14
Why Medical Device Importers Must Prioritize FDA Compliance: Lessons from a $550K Settlement
April 09, 2025 In the world of medical device imports, understanding and complying with FDA regulations  is paramount. Recently,...
Provision Consulting Group
6 days ago3 min read
12
Dexcom’s Growth Surge Amid Regulatory Scrutiny: A Lesson in MedTech Resilience
Monday, March 17, 2025 Introduction In the fast-paced world of medical technology, innovation often races ahead of regulation. Dexcom , a...
Provision Consulting Group
Mar 172 min read
22
FDA’s GRAS Rule Reform: What It Means for Food Safety and Ingredient Transparency in 2025
March 12, 2025 In a significant shift aimed at bolstering food safety and consumer trust, U.S. Health and Human Services Secretary Robert...
Provision Consulting Group
Mar 123 min read
73
Common Mistakes to Avoid Under MoCRA
March 10, 2025 Common Mistakes to Avoid Under MoCRA The Modernization of Cosmetics Regulation Act (MoCRA)Â has introduced significant...
Provision Consulting Group
Mar 102 min read
18
Food Additives Banned in Europe but Still Allowed in the U.S.: What Consumers Need to Know
March 10, 2025 When it comes to food safety, regulations can vary significantly between countries. While the European Union (EU) has...
Provision Consulting Group
Mar 102 min read
26
The FDA Bans Red No. 3 in Food and Drugs: What You Need to Know
March 04, 2025 The U.S. Food and Drug Administration (FDA ) Â has officially announced the revocation of Red No. 3 (FD&C Red No. 3) Â as a...
Provision Consulting Group
Mar 43 min read
86
Who Needs an FDA Initial Importer? Understanding the Requirements
January 30, 2025 Keyword Phrase: Â FDA Initial Importer Requirements Understanding the Role of an FDA Initial Importer If you manufacture...
Provision Consulting Group
Jan 303 min read
22
What Is an FDA Initial Importer? A Guide for Foreign Manufacturers
January 29, 2025 Keyword Phrase: Â FDA Initial Importer If you're a foreign manufacturer looking to sell medical devices,...
Provision Consulting Group
Jan 293 min read
27
FDA Releases New FAQ Updates for Cosmetic Facility Registration and Listing
December 12, 2024 The U.S. Food and Drug Administration (FDA) has released updated guidance for the cosmetics industry, focusing on the...
Provision Consulting Group
Dec 12, 20243 min read
18
Breaking Records: How We Achieved Fast FDA 510(k) Clearance in 1 Month
December 09, 2024 When it comes to navigating FDA regulations, achieving 510(k) clearance can feel like running a marathon. The process...
Provision Consulting Group
Dec 9, 20243 min read
28
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
133
Understanding Predicate Devices: The Key to FDA 510(k) Submissions
November 26, 2024 For medical device manufacturers, navigating the FDA's regulatory requirements is a critical step in bringing products...
Provision Consulting Group
Nov 26, 20243 min read
108
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
16
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
49
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
16
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
141
Why Pay More? Save on Initial Importer Fees with Provision Consulting Group
October 21, 2024 In today's global market, importing products into the U.S. comes with a variety of regulatory requirements. One of the...
Provision Consulting Group
Oct 21, 20243 min read
21
How to Determine Your Product’s FDA Category: Is It a Cosmetic, Dietary Supplement, OTC Drug, or Medical Device?
October 18, 2024 When bringing a product to market, one of the most important steps is figuring out how the FDA categorizes your product...
Provision Consulting Group
Oct 18, 20244 min read
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