ISO 13485 for Class 1 FDA medical device

Within Class I, if a device is classified into a general category of exempted devices, then no Premarket Notification application or FDA clearance is needed before selling the device in the U.S. But, the supplier is mandated to register its institution and submit a list of generic products to the FDA. These Class I devices are under the fewest regulatory controls. Class I devices that are not listed as exempted devices undergo a Premarket Notification application with the FDA.

The classification procedure and market approval processes are fully explained in the 21 CFR Part 860 (Code of Federal Regulations for Medical Device Classification Procedures). For the USA market, ISO 13485:2016 is not a regulation or law, however, while FDA 21 CFR Part 820 is mandatory for medical device distribution in the United States. 

For more detail on this topic, please see the following articles:

• How to use ISO 13485 to fulfill FDA regulatory classes for medical devices - https://advisera.com/13485academy/blog/2017/09/14/how-to-use-iso-13485-to-fulfill-fda-regulatory-classes-for-medical-devices/
• Differences and similarities between FDA 21 CFR Part 820 and ISO 13485 - https://advisera.com/13485academy/blog/2017/10/05/differences-and-similarities-between-fda-21-cfr-part-820-and-iso-13485/