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Which FDA Pathway for SaMD? 510(k), De Novo, or PMA (2025)
Choosing a SaMD pathway depends on risk, novelty, and predicates . Use 510(k) when a suitable predicate exists for the same intended use...
May 153 min read
SaMD Risk Categories (IMDRF): What They Mean & How They Relate to FDA Review
IMDRF categorizes SaMD risk (I–IV) by crossing significance of information (inform, drive, treat/diagnose) with the condition’s...
May 133 min read
FDA Unique Device Identification (UDI): Complete Guide for Medical Device Manufacturers
FDA’s UDI system requires most device labels and packages to bear a Unique Device Identifier —in human-readable and AIDC...
Dec 6, 20244 min read
STeP for Medical Devices: FDA’s Safer Technologies Program Explained
FDA’s Safer Technologies Program (STeP) is a voluntary pathway for devices (and device-led combos) that are reasonably expected to...
Nov 26, 20246 min read
How Long Can FDA Approval Take? Understanding Timelines for Different FDA Pathways
For medical device companies, understanding the FDA approval timeline is critical. Knowing how long the process might take helps companies plan more accurately, manage resources effectively, and set realistic expectations for investors and stakeholders. However, the time to obtain FDA approval can vary significantly depending on the regulatory pathway and the complexity of the device. This guide provides a breakdown of typical timelines for the major FDA approval pathways—510
Nov 12, 20246 min read
FDA Q-Submission (Q-Sub) Program: How Early Feedback Streamlines Approval
The FDA Q-Submission (Q-Sub) Program lets device teams request written feedback or a meeting before and during submissions. Core types...
Nov 6, 20245 min read
FDA Compliance Guide for Medical Device Startups
Startups can meet FDA requirements without burning runway by sequencing the right decisions in the right order. This guide shows how to...
Nov 5, 20245 min read
Beginner’s Guide to FDA Compliance for Medical Devices
FDA regulates medical devices from classification through postmarket monitoring. This beginner’s guide shows how to determine class and...
Oct 22, 20246 min read
How to Choose the Right Predicate Device for Your 510(k) Submission
When it comes to FDA submissions , selecting the right predicate device for your 510(k) submission is one of the most critical steps....
Oct 15, 20246 min read
Top 10 FDA Medical Device Regulatory Mistakes and How to Avoid Them
Navigating FDA regulations can feel like walking through a maze. One wrong turn, and your medical device’s path to market could face...
Oct 9, 20245 min read
510(k) Submission Checklist for Medical Devices: What to Include
A 510(k) shows your device is substantially equivalent to a cleared predicate. Use this checklist to build the submission in the order...
Oct 8, 20246 min read
The Hidden Costs of Non-Compliance: How Medical Device Companies Can Avoid Regulatory Pitfalls
Non-compliance with FDA regulations can significantly damage medical device companies, both financially and operationally. In this...
Sep 12, 20245 min read
Why FDA Approval Is Important: Ensuring Safety, Efficacy, and Trust in Medical Devices
In the world of medical devices, FDA approval is more than just a regulatory hurdle—it's a crucial process that ensures the safety and...
Sep 4, 20243 min read
Understanding FDA Device Classifications: Class I, II, and III Explained
For medical device manufacturers, understanding FDA device classifications is crucial for successful product development and regulatory...
Aug 29, 20243 min read
How to Get FDA Approval: A Step-by-Step Guide for Medical Device Companies
For medical device manufacturers, obtaining FDA approval is a critical milestone in bringing innovative products to market. This...
Aug 2, 20243 min read
How FDA Approval Works: A Comprehensive Guide for Beginners
If you're new to the medical device industry or considering bringing a medical device to market, understanding the FDA approval process...
Jul 25, 20246 min read
How Long Can FDA Approval Take?
For medical device manufacturers, bringing a new product to market involves navigating the complex landscape of regulatory compliance....
Jul 16, 20244 min read
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