How to Identify a Predicate Device? A Detailed Guide

by Sudhriti M | Oct 30, 2024 | Medical Device, Medical Device License Requirements

Planning to market your medical device in the US? Then, you will have to secure the US FDA 510(k) approval. For which you will require proper documentation and have to select the appropriate predicate device. You will need the predicate device to prove substantial...

US FDA 510(k) Dossier Preparation: Everything You Need to Know

by Sudhriti M | Oct 30, 2024 | Medical Device

510(k) submission is a specific type of regulatory premarket submission made to the Food and Drug Administration (FDA) for Class I, II, and III medical devices. This premarket submission is used to demonstrate evidence of substantial equivalence. The process is...

5 Pro tips for Hassle-Free US FDA 510(k) Submission

by Sudhriti M | Oct 30, 2024 | Medical Device

Compliance with US FDA regulations is mandatory for marketing and distributing medical devices in the U.S. The FDA 510(k) is a premarket submission process used to determine whether the medical device is safe and effective. Owing to incorrect application, thousands of...

Using Artificial Intelligence in Medical Devices Industry

by Sudhriti M | Sep 19, 2024 | Medical Device

Artificial intelligence is a powerful and disruptive domain in the field of computer science. It empowers machines with the ability to perform tasks that usually require human intelligence. Furthermore, artificial intelligence (AI) enabled-machines match or improve...

Recent Reminder for CDSCO License Retention Fee Payment

by Sudhriti M | Sep 14, 2024 | Medical Device

CDSCO license for medical devices manufacture/import and registration certificates for QMS medical device testing labs are valid indefinitely. All licenses, Form MD-5, Form MD-6, Form MD-9, Form MD-10, and Form MD-15, are issued for an indefinite period. The validity...