Premarket Notification Archives - Quality Smart Solutions

FDA guidance document on unclassified medical devices exempt from 510(k) requirements

FDA Issues Guidance Exempting Certain Unclassified Medical Devices from 510(k) Premarket Review

The U.S. Food and Drug Administration has released guidance clarifying regulatory expectations for unclassified medical devices and 510(k) premarket notification requirements, formally

July 3, 2026

FDA reviewer examining a 510(k) submission package for a dental device

Top Reasons 510(k) Submissions for Dental Devices Get Rejected (And How to Avoid Them)

Few things set back a product launch more painfully than a rejection letter from the FDA. When your 510(k) submission

May 10, 2026

FDA regulatory document illustrating proposed 510(k) exemptions for Class II devices including clinical toxicology test systems

FDA Moves to Expand 510(k) Exemptions for Certain Class II Devices, Including Clinical Toxicology Test Systems

The U.S. Food and Drug Administration published a notice in the Federal Register on May 1, 2026, announcing its intent

May 9, 2026

Regulatory professional reviewing FDA 510(k) submission documentation on a laptop

What to Do (and Avoid) in Your FDA 510(k) Submission Process

Getting an FDA 510(k) submission right the first time is one of the most consequential steps in your medical device’s path to market.

April 13, 2026