top of page
FDA Cleared vs FDA Approved vs FDA Granted: 2025 Complete Guide
In FDA device speak, cleared ≠ approved ≠ granted. Mixing these terms can misbrand your product. FDA cleared means 510(k) approval for...
Jul 117 min read
What Is FDA STeP Program (Safer Technologies Program)? Complete Guide 2025
FDA's Safer Technologies Program (STeP) is a voluntary program for devices reasonably expected to significantly improve safety of...
Jul 107 min read
What Is an FDA Medical Device Recall? 2025 Crisis-Prevention Guide
An FDA medical device recall is usually a voluntary action by a firm to remove or correct a product that violates FDA law , with FDA...
Jul 108 min read
What Is an SBOM? FDA Requirements for Medical Devices (2025 Guide)
A Software Bill of Materials (SBOM) is a machine-readable inventory of every software component in your device—proprietary, OTS, and...
Jul 99 min read
What Is cGMP for Medical Devices? QSR Today, QMSR in 2026
In FDA device world, “ cGMP ” obligations are implemented via the Quality System Regulation (21 CFR 820) . On Feb 2, 2026 , FDA’s Quality...
Jul 97 min read
What Is ISO 13485? QMSR 2026 Compliance Guide for Medical Devices
ISO 13485 is the international QMS standard for medical devices. In the U.S., FDA’s QMSR takes effect Feb 2, 2026 , incorporating ISO...
Jul 86 min read
bottom of page