OTC Medical Device Distributor

Show customers your facility’s dedication to safely distributing diagnostic OTC medical devices.

With over-the-counter (OTC) medical device distribution being largely unregulated in the United States, we created an accreditation for distributors of medical devices that are often designated as medium and high risk by the Food and Drug Administration. Our OTC Medical Device Distributor Accreditation plays a role in securing the medical supply chain by helping to protect the public from certain diverted or counterfeit medical devices.

This 3-year accreditation is for business entities that distribute diagnostic OTC medical devices that may be dispensed pursuant to a prescription.

Bundle Distributor Accreditations to Save Time and Money

Maximize your investment by also applying for our Drug Distributor Accreditation. Check eligibility requirements for your facility and contact our team for the discount code needed during the application process.

Box opening up with three spinning stars coming out

To become an accredited OTC Medical Device Distributor and display the accredited-facilities seal, business entities must undergo a criteria compliance review, which includes both off-site and on-site reviews of the business entity’s policies and procedures and operations.


To apply for an NABP accreditation, you must meet basic eligibility requirements. To be qualified to apply for the OTC Medical Device Distributor Accreditation, your facility must be an OTC medical device distributor. Review the eligibility requirements listed below.


Click on the links below to learn about each criterion: