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Per the FDA regulations can a medical device be class I despite that it is sterile?

#1
Dear all,

A device which a company is introduced to the market as sterile, the company state that it is class I device, per the FDA regulations can it be a class I device despite that it is sterile?

thank you in advanceNissim
 
Elsmar Forum Sponsor
#4
I have been trying to find the exemption of a sterility expiry requirement on Class I sterile devices (510(k) exempt). i notice that sterile Band-Aids, gauze, etc. are sterile with no expiry.

Can anyone weigh in?
 

Watchcat

Trusted Information Resource
#5
If they claim it is FDA anything, they should be able to tell you both the applicable FDA regulation number and product code.
The company should also have listed the device as one of the devices it markets in the US, in the FDA's Establishment Registration and Listing database:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm

The listing will have both the regulation number and product code. If you look up the regulation number, it will tell you the device class.
 
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