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Who can submit a Premarket Approval (PMA) for imports of medical devices?
The PMA applicant is usually the person who owns the rights, or otherwise has authorized access, to the data and other information to be submitted in support of FDA approval of the PMA. This person may be an individual, partnership, corporation, association, scientific or academic establishment, government agency or organizational unit, or other legal entity. Often times the applicant is the inventor/developer and ultimately the manufacturer. If the applicant does not reside or have a place of business within the U.S., the PMA must be countersigned by an authorized representative who does. [ยง814.20]
U.S. Food and Drug Administration (FDA)
http://www.fda.gov
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