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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
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