PMA Database for Medical Devices
PMA Database: Apprehend the Premarket Approval
Introduction
The Premarket Approval (PMA) process is a critical pathway that medical devices must navigate to ensure their safety and efficacy before reaching the market. Governed by the Food and Drug Administration (FDA), this rigorous evaluation is designed to protect public health by requiring manufacturers to provide substantial evidence that their devices are both safe and effective for their intended use. This article explains the PMA process and where to find the information regarding applications.
What is an example of a PMA device?
An example of a device that underwent the PMA process is the artificial heart valve. Artificial heart valves are life-saving devices used to replace damaged or diseased valves in the heart. These devices are categorized as Class III medical devices due to their high-risk nature, meaning they sustain or support life, are implanted, or present potential unreasonable risk of illness or injury.
To gain approval, manufacturers must provide extensive clinical and non-clinical data demonstrating the device's safety and effectiveness. This includes laboratory testing, animal studies, and human clinical trials. The data must show that the device will perform as intended in the real world and that the benefits outweigh any potential risks. The rigorous PMA process ensures that these complex devices are thoroughly vetted before they can be used in medical practice.
The PMA application process explained
There are 4 types of PMA application methods:
Each of them have their own specific requirements in terms of documentation that needs to be provided.
Phases of the PMA Evaluation Procedure
There are 4 steps in the review process of PMA applications:
Initial review: administrative and limited scientific review by FDA staff to determine completeness
Substantive review: in-depth scientific, regulatory, and Quality System review by appropriate FDA personnel
Panel review: review and recommendation by the appropriate advisory committee
Decision announcement: final deliberations, documentation, and notification of the FDA decision.
1. Initial review
The initial step after receiving a PMA application is an administrative review by the FDA. During this review, the FDA ensures that the application is complete and contains all the necessary documentation and data required for further evaluation according to the requirements of 21 CFR 814 and the PMA Acceptance and Filing Review Policy. This administrative review verifies that the application meets the regulatory requirements, including proper formatting, completeness of forms, and payment of applicable fees. Additionally, the FDA assigns a primary reviewer and establishes a review team consisting of experts from relevant disciplines such as clinical, engineering, and regulatory affairs.
Based on this review, the application will either be halted or will be accepted for further in-depth review. This decision is provided within 45 days after the FDA has received the application. If the FDA refuses the application, this is communicated to the applicant including the deficiencies in the application.
2. Substantive review
After the first initial review has been completed succesfully, the FDA will begin substantive review. Communication in this review phase is done via major/minor deficiency letters in which the FDA will require further information needed in order to complete the review of the application. The applicant may request to meet with FDA within 100 days of the filing of the PMA to discuss the review status of the application. This procedure is explained in the "Guidance on PMA Interactive Procedures for Day-100 Meetings and Subsequent Deficiencies - for Use by CDRH and Industry; Final"
The review period may be extended to 180 days if amendments are being made to the PMA which contain significant new or updated data.
3. Panel review
If needed, FDA may engage an outside expert panel, the advisory committee, to assess the safety and effectiveness of the device. This is only the case when there are no adequate in-house resources available. Also in this case, whenever additional information from the applicant is required by the advisory committee, this will be communication by the FDA.
4. Decision announcement
After reviewing the PMA application, FDA will communicate its decision. There are 4 possibilities:
Approval Order: this means the application is approved. Note that this is done on the basis of a draft label, which will still need to be finalized.
Approvable Letter: this means you're almost there and FDA believes it can approve the application if specific additional information is provided or specific conditions are agreed to by the applicant. When you receive an approvable letter, you have a few options:
Amend the PMA application as requested
Request an administrative review
Withdraw the application
Not Approvable Letter: the not approvable letter describes why the FDA believes it may not be able to approve the application. It lists the deficiencies in the application and what is necessary to make the PMA approvable. When you receive a not approvable letter, your options are:
Amend the PMA as requested. This will be considered a major amendment
Request an administrative review
Withdraw the application
Order Denying Approval
If the application fails to follow the requirements for PMA or if FDA has other grounds, FDA can deny the PMA application. The applicant will be informed about the deficiencies in the application.
PMA Database
Information regarding approved PMA applications can be found in a dedicated database.
In this database, information can be found by searching on e.g. applicants, product codes, device descriptions and PMA numbers.
Conclusion
The rigorous PMA process ensures that high-risk medical devices, such as artificial heart valves, are thoroughly evaluated for safety and effectiveness before reaching the market. Understanding its requirements as well as the full process is key to successfully bringing high risk devices to the US market.