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Premarket Approval (PMA)

When a medical device manufacturer wants to bring a new class III medical device to market, they must go through a rigorous premarket approval (PMA) process with the Food and Drug Administration (FDA). One of the most critical components of this process is the submission of clinical data to demonstrate the safety and effectiveness of the device.

Why Clinical Data Is Important

Clinical data is essential for the PMA submission process because it provides the FDA with the evidence needed to determine if a device is safe and effective for its intended use. If the PMA application lacks valid clinical information and scientific analysis on sound scientific reasoning, it could impact FDA’s review and approval of the application. More information on clinical studies for PMA submission can be found under PMA Clinical Studies on the FDA website.

FDA’s Expectation

The FDA expects PMA applicants to provide valid scientific evidence to determine whether there is reasonable assurance that the device is safe and effective. The agency affirms that valid scientific evidence can be provided from a well-established clinical investigation that produces quality controlled, verified clinical data. The clinical investigation is designed to gather scientific evidence to determine there is reasonable assurance of device safety.

According to the FDA, the extent of clinical evidence required varies and depends on the characteristics of the device, its conditions of use, the existence and adequacy of warnings and other restrictions, and the extent of experience with its use.

Safety

The FDA considers a device safe when it can be determined that the probable benefits to health from use of the device based on intended use and use environment outweigh any probable risks. Valid scientific evidence must adequately demonstrate the absence of unreasonable risk of illness or injury associated with the use of the device.

Effectiveness

The FDA expects that there is reasonable assurance that a device is effective when it can be determined that, in a significant portion of the target population, the use of the device for its intended use and in its use environment will provide positive clinically significant results. The agency expects that the scientific evidence used to determine the effectiveness of a device shall consist principally from a well-controlled investigation.

The following are some principles recognized by the scientific community as the essentials of a well-controlled clinical investigation:

Clear study objective(s)
Robust subject selection method (e.g., clear subject inclusion/exclusion criteria)
Adequate checks and measures to minimize bias by the subjects, observers, or data analysis.
Careful protection of human subjects and ethical review of the study when applicable
Explanation of and application of standardized methods for data collection
Statistically sound study data analysis and summary of results

Detailed requirements for a well-controlled investigation can be found under PMA Clinical Studies on the FDA website.

Why Choose Innovenn for your PMA Consulting Services?

By choosing Innovenn’s PMA consulting services, medical device manufacturers can benefit from our extensive experience and knowledge of designing and conducting clinical investigations that meet the FDA requirements and can help companies navigate the complex regulatory landscape. Innovenn’s consulting team supports medical device manufacturers, saving time and resources, and potentially reducing the risk of delays or costly deficiencies that could be discovered during the FDA review process.

To learn more about Innovenn’s PMA consulting services and how we can help you bring your medical device to market, contact us to discuss your specific needs.

Contact an Expert

Premarket Approval (PMA)

Why Clinical Data Is Important

FDA’s Expectation

Safety

Effectiveness

Why Choose Innovenn for your PMA Consulting Services?

Where healthcare innovation intersects with improved patient outcomes

Contact Innovenn

Stay Informed

The Importance of Clinical Data in Premarket Approval Submission for Medical Devices

Premarket Approval (PMA)

Why Clinical Data Is Important

FDA’s Expectation

Safety

Effectiveness

Why Choose Innovenn for your PMA Consulting Services?

Where healthcare innovation intersects with improved patient outcomes

Contact Innovenn

Stay Informed