US FDA Archives

What is the difference between US FDA 510(k) and PMA? A Guide

by Sudhriti M | May 24, 2025 | Medical Device

All medical devices entering the US market must comply with the regulatory requirements formulated by US FDA. These regulatory requirements are in place to ensure safe, effective, and high-quality medical devices reach the patients. The regulatory pathway required...

What Are the Latest US FDA Cosmetics Labelling Guidelines?

by Sudhriti M | Nov 30, 2024 | Cosmetics

Allergic reaction caused by contact with or consumption of allergens is a common issue. It can range from a mild rash to anaphylaxis that can even be fatal. Currently, there are extensive guidelines for labelling allergens in the food and beverage industry to protect...

Modernization of Cosmetics Regulation Act (MoCRA): Your Guide

by Sudhriti M | Nov 25, 2024 | Cosmetics

Recently, the US laws for cosmetics have changed. They have been made comprehensive. The Modernization of Cosmetics Regulation Act (MoCRA) has been implemented to modernize and transform FDA cosmetic regulations. The aim is to improve product safety and protect...

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...

What is the difference between US FDA 510(k) and PMA? A Guide

What Are the Latest US FDA Cosmetics Labelling Guidelines?

Modernization of Cosmetics Regulation Act (MoCRA): Your Guide

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

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