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OTC Medical Device Distributor > Preapplication

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What entities may apply for OTC Medical Device Distributor Accreditation?

Business entities that meet the definition of diagnostic OTC medical device distributor and can comply with the program’s criteria can apply.

For the OTC Medical Device Distributor Accreditation program, a “distributor” is a business that distributes to someone other than a consumer or patient. “Diagnostic” refers to a device used in medical diagnosis (eg, blood glucose test strips).