Overview of the 3 FDA Medical Device Classes: Which One Does Your Product Fit Into?

by Jeremy Moore | Nov 6, 2024 | US FDA Regulatory Requirements

Understanding FDA Medical Device Classes: Which One Does Your Product Fit Into?Why FDA Medical Device Classes MattersClass I Devices: Low Risk, Minimal OversightClass II Devices: Moderate Risk, More Stringent ControlsClass III Devices: High Risk, Maximum OversightHow...

The Role of a US Agent for FDA Submissions: What Global Companies Need to Know

by Jeremy Moore | Oct 23, 2024 | International Regulatory Requirement, US FDA Regulatory Requirements

Why a US Agent for FDA Submissions is essential: From 510(k) to PMAWhat Is a 510(k) Submission?The Role of a US Agent in the 510(k) ProcessWho Is a US Agent?Responsibilities of a U.S. AgentHow to Choose the Right U.S. Agent for Your 510(k) SubmissionRegulatory...

Navigating the 510(k) Submission Process: Your Step-by-Step Guide to FDA Clearance

by Jeremy Moore | Oct 2, 2024 | Compliance and Regulatory Guidance, US FDA Regulatory Requirements

The 510(k) Submission Process: A Critical Pathway to FDA ClearanceUnderstanding the 510(k) Pathway: What Is It and Who Needs It?Types of 510(k) Submission Process and When to Use ThemThe Step-by-Step 510(k) Submission ProcessTips for a Smooth 510(k) Submission...

FDA Breakthrough Device Designation: Benefits, Criteria, and Application Process

by Jeremy Moore | Sep 4, 2024 | US FDA Regulatory Requirements, Compliance and Regulatory Guidance

Introduction to FDA Breakthrough Device Designation?What is the FDA Breakthrough Device Designation?Benefits of FDA Breakthrough Device DesignationAccelerated Development and ReviewPriority Review and Interaction with FDAReimbursement AdvantagesMarket...

Top 5 Common Pitfalls in FDA Pre-Submission Meetings and How to Avoid Them

by Jeremy Moore | Aug 7, 2024 | Compliance and Regulatory Guidance, US FDA Regulatory Requirements

Introduction to FDA Pre-Submission MeetingsUnderstanding FDA Pre-Submission MeetingsCommon Pitfalls in FDA Pre-Submission Meetings1. Lack of Preparation2. Inadequate Data or Documentation3. Miscommunication or Lack of Clarity4. Not Defining Objectives Clearly5....

How to Classify Medical Devices: A Beginner’s Guide

by Jeremy Moore | Jun 11, 2024 | US FDA Regulatory Requirements, International Regulatory Requirement, Software as a Medical Device

Mastering Medical Device Classification: Your Essential Starting PointWhat is Medical Device Classification?Definition and PurposeOverview of Regulatory BodiesWhy Classification of Medical Devices MattersRegulatory ComplianceSafety and EfficacyMarket Access and...