FDA DM and /or Class I Life Saving

Edward Reesor

Trusted Information Resource
I have read 21 CFR 860.3 regarding medical device classifications, however I am confused by the term Class I LS/LS versus a regular Class I. Is a Class I LS an accessory for a Class II device?

Second question: For a device that is reusable and therefore requires a DM, does every component part require a DM or just the "main body"? We offer a Class II device which is composed on 17+ different parts, the majority of which do not have the room for a legible UDI. Because demand is very low, we have not offered it to the US market. I want to look forward as more jurisdictions require UDI and DM for reusable devices. ANy suggestions?

Your attention is much appreciated.
 
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