Notes from the FDA frontier.
153 posts and counting — every CDRH guidance, warning letter, and explainer worth your time.
FDA eSTAR for SaMD: What Changes After Oct 1 2025?
From Oct 1 2025, FDA will require all De Novo SaMD submissions via its eSTAR template. Learn what’s new, key sections, and get ready.
Which FDA Pathway for SaMD? 510(k), De Novo, or PMA - Complete Medical Device Guide
Learn when SaMD needs a 510(k), when De Novo applies, and when FDA requires a PMA.
SaMD Risk Categories (IMDRF): What They Mean & How They Relate to FDA Review
Learn the IMDRF SaMD risk categories, how they map to FDA Class I-III, and which levels trigger 510(k), De Novo, or PMA review.
Device Software Function (DSF): FDA’s AI Draft Definition
Learn how FDA’s draft guidance defines “device software function” and why it matters for AI devices.
Device Software Function (DSF): FDA’s AI Draft Definition
Learn how FDA’s draft guidance defines “device software function” and why it matters for AI devices.
What Counts as SaMD? FDA Definition in Plain English
Learn the FDA’s definition of Software as a Medical Device (SaMD), a 3‑step litmus test, common edge cases, and a free SaMD checker.
FDA Unique Device Identification (UDI): Complete Guide for Medical Device Manufacturers
Learn everything about the FDA’s Unique Device Identification (UDI) system, including compliance requirements, labeling rules, and GUDID submissions.
FDA Medical Device Recalls Explained: Causes, Consequences, and How to Avoid Them
Learn all about medical devices recalls, the consequences of FDA recalls, and actionable strategies to avoid them through rigorous testing and compliance.
FDA Form 483: What It Means and How to Respond Effectively
Learn what FDA Form 483 is, why it’s issued, and how to respond effectively. Discover common reasons for observations and proactive tips to avoid compliance issues.
STeP for Medical Devices: FDA’s Safer Technologies Program Explained
Learn about the FDA's Safer Technologies Program (STeP) for medical devices, including eligibility, benefits, and application process, to expedite your device's approval.
FDA Import Alerts: A Guide for International Medical Device Companies
Learn how FDA import alerts impact international medical device companies, common reasons for alerts, and strategies for compliance and removal.
FDA Import Refusals for Medical Devices: Causes, Process, and Tips to Avoid Them
Learn about FDA import refusals for medical devices, common reasons for rejection, the reconditioning process, and best practices for compliance. Join our webinar for more insights.
How Long Can FDA Approval Take? Understanding Timelines for Different FDA Pathways
Learn about FDA approval timelines for medical devices, including average times for 510(k), PMA, and De Novo pathways. Discover factors that impact approval speed and tips to streamline the process.
FDA Q-Submission (Q-Sub) Program: How Early Feedback Streamlines Approval
Learn how the FDA’s Q-Submission Program provides early feedback to improve your medical device approval process. Discover Q-Sub types, benefits, and tips for successful submissions.
FDA Compliance Guide for Medical Device Startups
Discover the unique FDA compliance challenges faced by medical device startups and learn strategies to navigate these obstacles. Find out how to overcome resource gaps, high costs, and documentation issues.
Post-Market Surveillance for Medical Devices: Ensuring Ongoing FDA Compliance
Learn the essential FDA post-market surveillance (PMS) requirements for medical devices. Discover best practices for maintaining compliance and safeguarding patient safety post-approval.
FDA Guide to AI/ML SaMD: Pathways, PCCP, and Evidence
Learn how the FDA regulates Artificial Intelligence and Machine Learning (AI/ML) in Software as a Medical Device (SaMD). Discover challenges, key guidelines, and future regulatory frameworks.
FDA's Software as a Medical Device (SaMD) Explained
Learn how the FDA regulates Software as a Medical Device (SaMD) and discover tips for navigating the submission process, addressing cybersecurity, usability, and validation challenges.
Beginner’s Guide to FDA Compliance for Medical Devices
Learn how to navigate FDA compliance for medical devices with this comprehensive guide. Understand classification, FDA standards, approval pathways, and how to handle recalls.
How to Respond to an FDA Warning Letter: Step-by-Step Guide
Learn how to respond to an FDA warning letter with this step-by-step guide. Get practical advice on minimizing business disruption while ensuring compliance.
How to Choose the Right Predicate Device for Your 510(k) Submission
Learn how to choose the right predicate device for your 510(k) submission with this step-by-step guide. Avoid common mistakes and strengthen your FDA submission.
Top 10 FDA Medical Device Regulatory Mistakes and How to Avoid Them
Learn the top 10 common mistakes in FDA medical device regulations and how to avoid them. Get actionable tips to ensure your compliance efforts stay on track.
510(k) Submission Checklist for Medical Devices: What to Include
Looking to submit a 510(k) to the FDA? Our checklist covers everything from device classification to testing, ensuring a smooth submission process.
FDA Warning Letters: What Every Medical Device Company Needs to Know
Discover everything medical device companies need to know about FDA updates and warning letters. Learn how to stay compliant, avoid penalties, and streamline your regulatory process with expert tips and tools like Complizen.