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NEWS & BLOGS
Blog: Blog2
US Shutdown Ending Imminent: Now is the 'Golden Time' for FDA Renewal
Major foreign news outlets, including CNN, are reporting that the US federal government shutdown is finally nearing its end. While an official termination announcement has not yet been made, the normalization of government operations is imminent. Once federal agency operations resume, medical device registration and renewal processes, which had been suspended, will fully restart. This period is historically the time when system delays and errors are most frequent, as companie
Provision Consulting Group
Nov 122 min read
The FDA is Down: What the US Shutdown Means for Industry, and How to Respond
The recent failure of the U.S. federal government to reach a budget agreement has led to a government 'shutdown'. While we're used to...
Provision Consulting Group
Oct 103 min read
FDA Labeling Errors: The Top Cause of U.S. Import Delays & Launch Failures
Have you ever had a seemingly perfect product unexpectedly delayed or detained at customs? One of the most common reasons for this is a...
Provision Consulting Group
Aug 42 min read
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
Apr 142 min read
FDA's Return-to-Office Challenges: Navigating Potential Delays in Regulatory Processes
March 21, 2025 The U.S. Food and Drug Administration (FDA) has recently mandated a comprehensive return-to-office policy, requiring...
Provision Consulting Group
Mar 212 min read
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
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
How to Select the Right FDA Initial Importer for Your Medical Device
February 3, 2025 Why Choosing the Right Initial Importer Matters Selecting the right FDA Initial Importer is a critical decision for...
Provision Consulting Group
Feb 32 min read
Who Can Act as an FDA Initial Importer for Medical Devices?
January 31, 2025 Understanding the Role of an FDA Initial Importer For foreign medical device manufacturers looking to enter the U.S....
Provision Consulting Group
Jan 312 min read
Who Needs an FDA Initial Importer? Understanding the Requirements
January 30, 2025 Keyword Phrase: FDA Initial Importer Requirements Understanding the Role of an FDA Initial Importer If you manufacture...
Provision Consulting Group
Jan 303 min read
What Is an FDA Initial Importer? A Guide for Foreign Manufacturers
January 29, 2025 Keyword Phrase: FDA Initial Importer If you're a foreign manufacturer looking to sell medical devices,...
Provision Consulting Group
Jan 293 min read
Navigating FDA Regulations: Importing Medical Devices into the U.S.
January 10, 2025 Importing medical devices into the United States is a complex process that requires strict adherence to regulations set...
Provision Consulting Group
Jan 103 min read
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