To assist you in this crucial decision, we’ve outlined four popular PMA application methods for medical devices. Use this guide to identify the application method that best suits your business, streamlining FDA approval for your new medical device.

Understanding PMA Submissions

PMA submissions are designed to protect the American public from the risks associated with defective high-risk medical devices. Class III devices, those sustaining and supporting life or implanted within the body, are treated with the highest level of caution by the FDA. They must pass through the PMA filing process before being cleared for marketization.

The Importance of PMA for Medical Devices

PMA submissions are crucial because they guarantee the quality, safety, and integrity of critical life-saving devices, ensuring patients trust and benefit from them. If you’re a Class III device manufacturer, completing a PMA submission is a necessity. Given the high risk of patient injury or death associated with these devices, proving their proper functionality and robust medical device quality management system is paramount. This is where the PMA submission becomes a critical hurdle on your path to the US market.

Understanding the PMA Submission Process

To achieve first-time success with PMA submissions, you need in-depth knowledge and confidence in the process. Let’s start with how to prepare for your PMA submission journey.

Preparing for a PMA Filing

Begin your PMA submission journey by ensuring it applies to your device. Verify if your device is indeed a Class III device by checking the FDA’s PMA database for similar devices. Once you confirm that a PMA filing is right for your device, determine which PMA submission type best suits your operation. Small businesses should consider completing FDA Form 3602 to secure small business status, which reduces the PMA submission fee by $331,000.

After selecting your PMA filing route, organize your PMA submission components.

Requirements for PMA Submissions

PMA submissions, given the high-risk nature of Class III devices, are rigorous and comprehensive. Your PMA filing will require documentation, including device descriptions, technical data, reports, financial certifications or disclosure statements, samples, and labels.

FDA PMA Review Timeline

The FDA PMA submission process takes time due to its depth and rigor. It typically lasts about 180 days, twice as long as the 510(k) process for medium-risk devices. The PMA submission review involves four key steps:

1. Initial review to ensure completeness.
2. A substantive review where the FDA evaluates the submission and may request clarification.
3. A panel review for particularly unique devices.
4. A decision announcement within 180 days of the substantive review’s start.

The Four PMA Application Methods for Medical Devices

All Class III medical device manufacturers must secure PMA before marketing their products. In most cases, the FDA approval process rarely exceeds 180 days. There are four PMA application methods: traditional PMA, modular PMA, product development protocol (PDP), and humanitarian device exemption (HDE).

1. Traditional PMA: This is the most common method for FDA clearance, ideal for manufacturers with completed clinical testing. CFR 21 Part 814 outlines specific requirements and documents. Start with a device summary and answer key questions about your device.
2. Modular PMA: Designed for devices without completed clinical testing, this method involves completing designated “modules” submitted to the FDA. Final confirmation comes when all sections are completed.
3. Product Development Protocol (PDP): Tailored for devices using FDA pre-approved technology, especially Class III devices. Applicants submit “milestone reports” to demonstrate device effectiveness and safety.
4. Humanitarian Device Exemption (HDE): Ideal for devices serving individuals affected by rare “orphan” diseases. Since clinical evidence is challenging to gather, applicants must prove device performance and safety. Unique marketing and labeling requirements apply, and manufacturers cannot profit from HDE products.

Streamlining the PMA Application Process

To expedite your Class III device’s time to market, ensure you’ve selected and prepared for the right PMA application method from the outset. Investing in a medical device Quality Management System (QMS) is another key step to streamline the process. Many Class III manufacturers are adopting electronic Quality Management Systems (eQMS) to accelerate and simplify PMA submissions.

In summary, don’t leave the success of your PMA submission to chance. RABT provides a best-in-class eQMS for medical device companies.