Introduction to Premarket Approval (PMA)

Premarket approval (PMA)

- FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class Ill medical devices.

Due to the level of risk associated with Class Ill devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of Class Ill devices.

Therefore, these devices require a premarket approval (PMA) application under section 515 of the FD&C Act to obtain marketing approval.

- PMA is the most stringent type of device marketing application required by FDA. The applicant must receive FDA approval of its PMA application prior to marketing the device. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s).

- 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. This person may be an individual,

partnership,

corporation,

association, scientific or academic

establishment, government agency or organizational unit, or other legal entity. The applicant is often the inventor/developer and ultimately the manufacturer.

When a PMA is Required

PMA requirements apply to Class III devices, the most stringent regulatory category for medical devices. Device product classifications can be found by searching the Product Classification Database. The database search provides the name of the device, classification, and a link to the Code of Federal Regulations (CFR), if any. The CFR provides the device type name, identification of the device, and classification information.
A regulation number for Class III devices marketed prior to the 1976 Medical Device Amendments is provided in the CFR. The CFR for these Class III devices that require a PMA states that the device is Class III and will provide an effective date of the requirement for PMA. If the regulation in the CFR states that "No effective date has been established of the requirement for premarket approval," a Class Ill 510(k) should be submitted.
Please note that PMA devices often involve new concepts, and many are not of a type marketed prior to the Medical Device Amendments. Therefore, they do not have a classification regulation in the CFR. In this case, the product classification database will only cite the device type name and product code.