Jun 10, 2021 Kelly Stanton

4 PMA Application Methods for Medical Devices

Choosing the correct Premarket Approval (PMA) method can mean the difference between the success or failure of your growing medical device startup or scale-up. 

Pick the wrong application method, and you’ll end up wasting valuable time, energy, and capital.

This wasted effort can stifle business growth overnight. In fact, recent studies indicate that 20 percent of life sciences organizations fail within the first year of business. 

For some life sciences startups, the approval process can be slow and arduous.

So what’s the best way to improve your chances of startup success and achieve rapid approval? 

Start by identifying the appropriate PMA application method for your unique medical device. It’s a relatively simple step that will pay significant dividends later.

To help you out, we’ve identified four popular PMA application methods for medical devices. Use this guide to quickly and easily identify the application method that your business should follow to streamline FDA approval for its new medical device.

What are the 4 PMA Application Methods for Medical Devices?

All medical device manufacturers must secure PMA before manufacturing, marketing, and distributing products. In most cases, barring any unforeseen issues or circumstances, the FDA approval process rarely takes longer than 180 days in total.

There are four types of PMA application methods, including a traditional PMA, modular PMA, product development protocol (PDP), and humanitarian device exemption (HDE).

During the approval process,  you demonstrate a commitment to product quality. Many medical device manufacturers invest in quality management system (QMS) solutions designed to improve document management, design control, training, quality reporting, and more. Unfortunately, paper-based and other traditional “systems” rarely deliver the intelligence necessary for rapid and sustained regulatory approval.

Beyond investing in a modern and advanced QMS from the outset, you can maximize your chances for FDA approval by reviewing the top four PMA application methods listed below.

1. Traditional PMA

Traditional PMA is the most common method for achieving FDA clearance. This is an ideal application method for manufacturers that have already completed clinical testing.

CFR 21 Part 814 outlines the unique requirements and documents needed to achieve rapid approval. Typically, applicants start by creating a brief summary of their devices.

As you prepare your own device summary, try to answer the following questions:

  • What is the intended application of the device?
  • What technical data can you provide to prove device reliability and effectiveness?
  • Does the device align with major performance standards?

When submitting an application using the traditional PMA method, you must submit an electronic copy (eCopy). Before submitting your application, reference the Premarket Approval Application Filing Review to benchmark your application against the process/requirements set forth by PMA reviewers. 

RELATED READING: How to Shrink the FDA Medical Device Approval Timeline

2. Modular PMA

Modular PMA is a well-designed application method for devices that have not completed clinical testing. To achieve FDA approval, applicants must complete designated “modules.” Each completed module is submitted to the FDA, and final confirmation is granted once the applicant completes all sections of the PMA. 

It’s a relatively simple process that helps to create a well-designed (and compliant) medical device over time. Additionally, the PMA Shell makes it easy to understand what’s required during each phase of the application.

For a complete list of Modular PMA requirements, review the following documents: Premarket Approval Application Modular Review

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3. Product Development Protocol

Product development protocol is another PMA application method. This process is tailor-made for medical devices that utilize technology pre-approved by the FDA. Additionally, Class III devices may benefit from this approval pathway.

Applicants are required to submit “milestone reports” that outline all design and development outputs. In short, these milestone reports are used to demonstrate device effectiveness and safety. The interaction with the FDA through PDP allows applicants to quickly and easily address safety issues before financial resources are fully expended.

RELATED READING: 5 FDA Pre-Submission Tips for Medical Device Manufacturers 

4. Humanitarian Device Exemption

Humanitarian device exemption is the best FDA approval pathway for medical devices used to serve individuals affected by “orphan” diseases. Because these diseases affect less than 8,000 patients per year, it is difficult to gather clinical evidence proving the device’s therapeutic effectiveness. 

As a result, applicants must demonstrate that the device performs as intended and is safe for use. Additionally, there are some unique marketing and labeling requirements that manufacturers must comply with. Finally, the FDA prevents manufacturers from profiting off of HDE products.

For a complete list of HDE requirements, visit Humanitarian Device Exemption Program: Guidance for Industry and Food and Drug Administration Staff

How to Streamline the PMA Application Process

What’s the best way to decrease your product’s time to market? It’s easy: Make sure that you’ve selected the right PMA application method from the start.

It goes without saying that investing in a QMS is another simple step that you can take to streamline the PMA application process. In your search for an enterprise-class QMS, preparation is key. 

Download our free resource: 12 Questions to Ask Before You Buy an eQMS.

To help you get started on the right foot, we’ve created a simple guide that outlines the top questions you need to ask prospective QMS vendors.

Read it to learn about how to find a QMS that aligns with your organization’s unique needs, fits within your current budget, and offers all of the features you need to scale.

 

Whatever you do, don’t leave quality to chance. Qualio offers a best-in-class QMS for the life sciences industry. We’ve worked with hundreds of industry-leading medical device and biopharmaceutical organizations, including Linical, IRISYS, and Cirris.

How will you use quality to create a competitive advantage? We can’t wait to find out.

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Published by Kelly Stanton June 10, 2021