News|Videos|September 30, 2025

Regulatory Guidance for Medical Devices

Name: Regulatory Guidance for Medical Devices
Uploaded: 2025-09-30T15:03:55.352Z
Duration: 4 min 13 s
Description: Regulatory compliance for medical devices varies drastically based on the class type by the FDA.

Author(s)Sharon Ward-Fore, BS, MS, MT(ASCP), CIC, FAPIC, Whitney A. Casey, MHA, MBA, BBA, BA

Regulatory compliance for medical devices varies drastically based on the class type by the FDA.

This video dives into the FDA and Spaulding Classifications for medical devices. Based on where a medical device falls on these scales, Instructions for Use (IFU) will vary. It also covers the testing and monetary costs for disinfectants.

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