PMA approval is similar to the NDA approval for drugs insofar as “gold standard” clinical trials must be completed to provide solid clinical evidence of safety and efficacy. The process can take an excruciatingly long time but, irrespective of how good your product is or in how many patients it’s already been successfully used, this is the process you have to follow for PMA approval.
PMA approval won’t happen in the next 12 months. After enrolment, patients have to be treated and monitored over months. Then time is needed for data compilation, submitting the application and for the FDA review process.
PMA approval is similar to the NDA approval for drugs insofar as...
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