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  • FDA requires specimen collection from three "geographically diverse locations" for clinical studies for IVD medical devices. FDA also requests that the collection yield at least 50 positive samples to be measured at each test site. Channeling specimen collection from geographically diverse collection sites can be quite a challenge to accomplish...

  • Do any of you have recommendations for an International Regulatory Management System -that is affordable- where we can manage all our product registrations, license numbers and expiration dates for over 125 countries? We have looked at a few systems, but they are all too expensive and are mostly pharma based. We need a simple, medical device...

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    RE: Research Use Only

    Gary, "active medical devices performing a biopotential data acquisition function when attached to a subject, but not intended for clinical monitoring of the subject..." Your above-statements invoke the following regulations based on 1). a medical device; 2). a human subject; 3). for investigational use or for research use. 21...

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