FDA Premarket Approval (PMA) Review, Audit & Tips

Learn What Medical Device Manufacturers Need to Know About FDA Premarket Approval

The U.S. Food and Drug Administration (FDA) requires premarket approval (PMA) for new Class III medical devices. Medical device manufacturers seeking premarket approval must submit an application to the FDA, and they must provide the FDA with sufficient information to assess their devices’ safety and effectiveness. As the FDA explains:

“An approved Premarket Approval Application (PMA) . . . is, in effect, a private license granted to the applicant for marketing a particular medical device. A Class III device that fails to meet PMA requirements is considered to be adulterated under Section 501(f) of the act and cannot be marketed.”

While securing premarket approval is essential for bringing new Class III devices to market, the PMA application process is far from straightforward. To ensure that the review process goes as smoothly as possible, manufacturers submitting PMA applications must have all required safety and effectiveness data readily available, and they must be prepared to work with the FDA during its review. At Oberheiden P.C., we rely on extensive experience (including prior experience at the FDA) to manage the PMA application process for our clients, guiding them step-by-step while communicating with the FDA on their behalf.

FDA Premarket Approval Application and Pre-Market Approval Review: An Overview

The FDA premarket approval application process is complicated. There’s simply no other way to put it. As a result, an informed and structured approach is critical, and this starts with gaining a basic understanding of the major steps involved in the process:

• Determining Whether a PMA Application is Required – The first step is determining whether a PMA application is required. As noted above, the PMA submission process is required for many (but not all) Class III medical devices. When a PMA application is not required, manufacturers can take advantage of the FDA’s more streamlined 510(k) premarket notification process.  
• Preparing the PMA Application – Once you determine that a PMA application is required, the next step is to prepare the application. This itself is a time-intensive process that requires an in-depth understanding of all pertinent statutory and regulatory requirements. 
• Preparing Substantiating Data and Documentation – In conjunction with preparing their PMA applications, medical device manufacturers seeking FDA approval must also prepare all necessary substantiating data and documentation. Being able to clearly demonstrate a new device’s safety and effectiveness is critical to securing FDA approval. 
• Working with the FDA During Its Regulatory Review – After submitting their PMA applications, manufacturers should expect to work with the FDA as the FDA will begin substantive review. Answering questions and providing substantiating documentation promptly will help ensure that the process is as efficient as possible. 
• Finalizing the Review Process and Determining Next Steps – At the end of the FDA’s review and after receiving the advisory committee report, manufacturers must determine their next steps. If the FDA approves a device, a key next step is to begin preparing for the FDA’s first postmarket inspection (discussed below). If the FDA denies approval, then manufacturers will need to work with their counsel to determine what options they have available based on the reason for the denial. 

Again, this is a broad overview of the major steps in the FDA PMA application and review process. Premarket approval applications are subject to detailed requirements; and, depending on the nature of the device, manufacturers may need to meet additional requirements as well. For example, special requirements apply to PMA applications for devices regulated by the FDA’s Center for Biologics Evaluation and Research (CBER). Our lawyers and consultants have the knowledge and experience required to assist manufacturers with the PMA process in all scenarios; and, if you have questions about submitting a PMA application to the FDA, we invite you to contact us for more information.

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What Medical Device Manufacturers Need to Know About FDA PMA Postmarket Inspections (PMA Audits)

All medical device manufacturers that secure PMA approval are subject to PMA postmarket inspections (or PMA audits) conducted by FDA personnel. As the FDA explains:

“The PMA postmarket inspection will assess the firm’s systems, methods, and procedures for the specific devices to ensure that the firm’s quality management system is effectively established (defined, documented, and implemented) and effectively maintained. The PMA postmarket inspection should also confirm that commitments made by the firm at the time the applications were approved have been completed or are underway in accordance with those commitments.”

As a result, facing a PMA audit can be a high-risk scenario. If the FDA determines that a device manufacturer’s systems, methods, or procedures are deficient in any respect, it can impose various administrative penalties (including revocation of approval). In severe cases, failed PMA audits can lead to civil monetary penalties and other consequences as well.

5 Tips for Submitting FDA Premarket Approval Applications

With all of this in mind, what do you need to know if you are preparing to go through the FDA’s premarket approval process? Here are five tips for medical device manufacturers:

1. Start Preparing for the PMA Application Process Early

Due to the amount of work involved in preparing a PMA application for submission to the FDA, it is important to start the process early. This will help ensure that your application is ready when you are ready to file.

2. Anticipate the FDA’s Questions and Concerns

As you work with your counsel to prepare your PMA application, you should try to anticipate the FDA’s questions and concerns. The more you can do to address these proactively, the smoother the application process will go.

3. Focus on Data and Documentation

When reviewing PMA applications, the FDA focuses on data and documentation. This means that you should be focused on data and documentation, too. Securing premarket approval requires clear and comprehensiveness of a new Class III device’s safety and effectiveness.

4. Focus on the Details

Along with focusing on data and documentation, it is also important to focus on the details. When seeking premarket approval from the FDA, overlooking details can lead to a denial that could (and should) have been avoided.

5. Remember: Securing PMA Approval is Just the Start of the Process

Finally, it is important to keep in mind that securing PMA approval is just the start of the FDA compliance process. Once the FDA approves a manufacturer’s new device, the manufacturer will need to begin preparing for the FDA’s PMA audit and implement a comprehensive FDA compliance program that effectively mitigates its risk on an ongoing basis.

FAQs: FDA Premarket Approval for Class III Medical Devices

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