What is a Premarket Approval (PMA)?

Premarket Approval (PMA) Definition

A premarket approval (PMA) is the most stringent type of device marketing application required by the FDA. Submittal of a PMA is required by the FDA and is the process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. There are two main paths that medical device manufacturers can use to bring moderate- and high-risk devices to market with the FDA’s permission: through submittal of a PMA request or 510(k) application. A PMA is the more extensive approach, requiring significant evidence that provides “reasonable assurance that the device is safe and effective” through methods like clinical trials. This process is reserved for high-risk Class III medical devices.

FAQs

What is the difference between 510(k) and PMA?

Premarket approval (PMA) is typically required for higher risk Class III medical devices. As part of the PMA application, extensive scientific evidence in the form of laboratory and clinical trial data must be submitted to demonstrate the safety and effectiveness of the device. Devices in lower risk categories that do not require PMA will most likely require a 510(k) premarket notification. The 510(k) is a faster and less expensive submission route that can be used if the device is substantially equivalent to a device that is already cleared by the FDA.

What goes into a PMA?

Separate sections on nonclinical laboratory studies and clinical investigations involving human beings must be included in the PMA. All copies of the PMA must include trade secrets or proprietary commercial or financial information.

Source: https://www.fda.gov

How long does a PMA take?

The FDA’s examination of a premarket approval application is meant to take six months but it can, and often does, take longer.

*Source: https://www.drugwatch.com

The Cost
of
Mistakes

Delivering new products to market is challenging. And It is difficult to see the cost impact of one or more mistakes.

Try our calculator to estimate the impact on your business. Input your business details, select a challenge, and see the real-world cost impact as validated by our customers.