US FDA Archives

Mistakes in FDA Device Approval Submissions & How to Avoid Them

by Sudhriti M | Mar 16, 2026 | Medical Device

To launch your medical device in US, you will require FDA medical device approval. Broadly classified there are three types of FDA regulatory pathways, namely 510(k), De Novo, PMA, for FDA medical device approval. It is important to choose the correct regulatory...

Differences Between Substantial Equivalence and Predicate Device

by Sudhriti M | Mar 14, 2026 | Medical Device

Identifying the correct predicate device is the first critical step in US FDA 510(k) submission. The FDA authorities evaluate whether your device is substantially equivalent to the predicate device you have mentioned in the application. If it is equivalent, then your...

Understanding US FDA Product Recall: Your Comprehensive Guide

by Sudhriti M | Mar 13, 2026 | Cosmetics, Medical Device, Pharmaceutical

With increasing complexity of FDA regulated products and critical nature of patient safety, proper management of product recalls is essential. Hence, understanding US FDA product recalls is of vital importance to remain compliant. A US FDA product recall is an...

FDA Breakthrough Device Designation: Criteria & Application

by Sudhriti M | Mar 12, 2026 | Medical Device

In this blog, we will walk you through FDA breakthrough device designation, its eligibility criteria, and application process. Additionally, we will present the benefits and challenges of the FDA’s breakthrough devices program. What is an FDA breakthrough device? An...

10 Common Reasons for US FDA Submission Denials to Avoid

by Sudhriti M | Mar 3, 2026 | Medical Device

The U.S. Food and Drug Administration (FDA) serves as the primary regulatory authority for medical devices in the United States. It is responsible for protecting public health. The U.S. FDA accepts several types of submissions depending on the product category, risk...

Mistakes in FDA Device Approval Submissions & How to Avoid Them

Differences Between Substantial Equivalence and Predicate Device

Understanding US FDA Product Recall: Your Comprehensive Guide

FDA Breakthrough Device Designation: Criteria & Application

10 Common Reasons for US FDA Submission Denials to Avoid

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