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FDA Premarket Approval (PMA) Application Medical Devices

Expert guidance for each phase of your FDA PMA approval effort including pre-submission collaboration with the FDA, clinical trial management, quality system compliance and final FDA registration.

What Is Premarket Approval (PMA)?

Premarket approval (PMA) is the scientific and regulatory review FDA conducts to evaluate the safety and effectiveness of Class III medical devices – those devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential, unreasonable risk of illness or injury. Due to the level of risk associated with Class III devices, FDA decided that general and special controls alone are insufficient to ensure the safety and effectiveness of such devices.

PMA is the most stringent type of device marketing application required by FDA. Applicants must receive FDA approval of their PMA application prior to marketing the device. FDA issues this approval when the PMA contains sufficient, valid scientific evidence to ensure that the device is safe and effective for its intended use(s).

Oriel STAT A MATRIX can provide expert assistance to help your organization prepare and submit an original PMA application and/or a PMA supplement.

Consulting and Coaching for PMA Submissions

Oriel STAT A MATRIX’s comprehensive approach to FDA PMA submissions ensures that your PMA addresses all of the necessary elements, making the entire process more efficient and accurate.

Count on a proven approach to develop your PMA submission. Oriel STAT MATRIX’s medical device experts will work with you to:

  • Identify the appropriate regulatory pathway, ensuring that a PMA is actually required for your device before you expend time and resources working on an application.
  • Select the relevant guidance documents.
  • Apply the PMA pathway.
  • Support each phase of the submission process as needed, including:
    • Coaching staff throughout the submission process and transferring expertise to your organization for future use.
    • Facilitating the presubmission process.
    • Obtaining an investigational device exemption.
    • Developing an investigational plan.
    • Designing clinical trials.
    • Compiling each module of the PMA submission.
    • Responding to postsubmission questions from the FDA.

In addition to offering directed consulting and coaching, we also have a training course, Medical Device Submissions in the US and EU [Emphasizing the 510(k) and CE Mark], designed to help you understand the FDA and EU Medical Device Directives submission processes. Take the course in cities throughout the United States, or we can bring the course to your site.

Provided below are a variety of practice related white papers, market updates and case studies.

The FDA 510(k) Process: Improving Your Odds of Success and Shortening Approval Time

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