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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
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