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6. Win FDA Approval and Avoid Costly Mistakes: Build a Regulatory Strategy for Your Medical Device

1️⃣ What is a regulatory strategy? A regulatory strategy is a working, living plan that balances product development, design, risk management, testing, and go-to-market strategy with FDA expectations. Hence, your medical device enters the U.S. market efficiently and in compliance. It’s not a paper exercise or a “submission plan.” It:✅ Determines device classification, product code, … Read more

5. Master the FDA De Novo Pathway: Bring Your Breakthrough Medical Device to Market with Confidence

Your Guide to FDA De Novo Success 1️⃣ What is the FDA De Novo Pathway?The FDA De Novo pathway was created to help new, low-to-moderate-risk medical devices that don’t have a similar product already on the market to get approved for sale in the U.S. If your device is new, with no significant equivalence available … Read more

4. Tips to Have a Successful FDA Pre-Submission (Q-Sub) Meeting for Your Medical Device

FDA Pre-Submission (Q-Sub) Get the Answers You Need Before Submission ???? What is the FDA Q-Submission (Q-Sub) Program?The FDA Q-Sub Program is a formal procedure through which medical device firms can get early, organized FDA feedback before submitting a 510(k), De Novo, PMA, or other submissions. Key facts:✅ It is a voluntary, complimentary program.✅ Allows … Read more

3. Avoid FDA eSTAR Filing Mistakes and Accelerate Your 510(k): A Step-by-Step Guide to Faster Submission

File Smarter with FDA eSTAR What is FDA eSTAR?eSTAR (Electronic Submission Template and Resource) is:✅ Smart, interactive PDF template for preparing and submitting 510(k) and De Novo submissions.✅ Guides you step by step, section by section, allowing you to enter all the data needed.✅ In each section has embedded links to FDA guidance to avoid … Read more

2. Avoid FDA 510(k) Rejections and Win Fast Approval: Top 10 Mistakes and How to Prevent Them

Your Roadmap to a Successful FDA 510(k) Submission Without Painful Setbacks 1️⃣ Incomplete Submission Package ❌ What Goes Wrong (In-Depth): FDA uses the Refuse-to-Accept (RTA) checklist to review 510(k) submissions for completeness before substantive review. Without key administrative or technical components, the submission is rejected outright without review, and delays are incurred immediately. Missing pieces, … Read more

1. Master FDA 510(k), PMA, and De Novo: Your Guide to Medical Device Approval Pathways & Don’t Get Stuck

Introduction If you’re developing a medical device for the U.S. market, one of the first and most important regulatory questions is “Which FDA approval pathway applies to my device?” The United States Food and Drug Administration (FDA) oversees medical devices in the Center for Devices and Radiological Health (CDRH). The FDA categorizes devices based on … Read more

About this Blog

Welcome to Regulatory MedTech Insights your trusted source for insights into the complex world of medical device regulation. Professionals, start-ups, and entrepreneurs seeking clear, actionable, and up-to-date regulatory information in the medical device industry are the target audience for this blog. You are perhaps a regulatory specialist, a quality manager, a medtech start-up, or just … Read more