PMA

If you have a new type of device that is not in the FDA’s product classification database or is a high risk device and has been found to be not substantially equivalent to a Class I, II, or III [Class III requiring 510(k)] device, then the device must have an approved PMA before it can be marketed in the U.S.

Whether you require assistance in writing the entire application or ensuring the FDA is being provided enough detail to make an assessment of the quality control used in producing your device, AlvaMed’s experienced regulatory consultants can provide the support you need.
 

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