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HI Experts,
I work with a small company which makes a non significant risk medical device. They are planning to do a small safety and efficacy study in US. Do they need to get at least IRB approval? or since its a small study with a very low risk device, they can do the study without any approval from FDA or IRB. Please suggest?
Thanks!
I work with a small company which makes a non significant risk medical device. They are planning to do a small safety and efficacy study in US. Do they need to get at least IRB approval? or since its a small study with a very low risk device, they can do the study without any approval from FDA or IRB. Please suggest?
Thanks!
so much Ronen and Mihzago!!