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FDA Form 483: What It Means and How to Respond Effectively
Form FDA 483 (Inspectional Observations) lists conditions FDA investigators observed at the end of an inspection. It is not a final...
Nov 29, 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
FDA Import Alerts: A Guide for International Medical Device Companies
An FDA import alert flags products/firms that appear to violate the law and allows detention without physical examination (DWPE) ....
Nov 21, 20244 min read
FDA Import Refusals for Medical Devices: What They Are and How to Avoid Them
An FDA import refusal is the agency’s final decision that a detained shipment violates FDA laws. Once refused, the shipment must be...
Nov 14, 20245 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
Post-Market Surveillance for Medical Devices: Ensuring Ongoing FDA Compliance
FDA postmarket surveillance means monitoring safety, investigating complaints, filing MDRs within 30 days (or 5-day in certain cases) ,...
Oct 31, 20244 min read
FDA Guide to AI/ML SaMD: Pathways, PCCP, and Evidence
FDA regulates AI and ML in SaMD using existing device pathways plus AI-specific expectations. Key elements include the 2025 PCCP final...
Oct 29, 20245 min read
FDA's Software as a Medical Device (SaMD) Explained
As technology continues to transform healthcare, Software as a Medical Device (SaMD) has become crucial in diagnostics, treatment, and...
Oct 25, 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 Respond to an FDA Warning Letter: Step-by-Step Guide
An FDA warning letter is a public notice of significant violations that requires a written response within 15 working days. This...
Oct 17, 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
FDA Warning Letters: What Every Medical Device Company Needs to Know
An FDA warning letter is a public notice that a company significantly violated medical device regulations. Common triggers include QMS...
Sep 20, 20244 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
Can FDA Approval Be Revoked? A Comprehensive Guide for Medical Device Companies
TL;DR: Revocations are rare . FDA far more often uses recalls , warning letters , or temporary suspensions to correct problems before...
Aug 8, 20245 min read
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