When marketing a medical device, you will need clearance from the Food and Drug Administration (FDA). It is a rigorous process, and there are substantial fees. Medical device falls under three classes, and required submissions will depend on what class your device is assigned. Information relevant to the FDA approval process is broken down into sections below so that you can easily follow through the steps.
Interested in working with an experienced FDA compliance consultant, contact Shehadeh Giannamore, PLLC at (305) 507-9843 for the best FDA compliance services. You can also visit us online for more details.
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