What is the Premarket Approval (PMA)
Pathway?
The most stringent type of device marketing application required by FDA, Premarket approval (PMA) is the US FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are defined by the FDA as 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 high-risk nature of these devices, the FDA requires additional regulatory and scientific review of these devices over devices in lower-risk categories.
These submissions must demonstrate the device meets product-specific safety and efficacy standards set by US regulatory agencies and prove the device is substantially equivalent to a predicate device (a device that has already been cleared by the agency for commercialization in the US) to be granted market authorization.
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What is Included in a PMA?
Due to the complexity and risk of the devices this pathway reviews, PMA applications require significantly more safety and efficacy data than other product approval pathways. In addition to providing safety and efficacy documentation, the applicant must also include administrative documents, details about how the device was designed, how it was manufactured, and information about the labeling of the device.
Data Requirements and Formatting
The agency states that the key to approval of a PMA application rests on “good science and scientific writing”. If a PMA application lacks valid clinical information and scientific analysis on sound scientific reasoning, it could result in the denial of the application. Additionally, the agency requires this information be presented in a clear and well-organized format. Applications that are incomplete, inaccurate, inconsistent, omit critical information, and poorly organized have resulted in delays in approval or denial of those applications.
PMA Applications Require Sections for:
Technical Data
This section includes data and other information to inform the agency’s decision on whether to approve the application. This section must be separated into two sections: Non-Clinical Studies and Clinical Studies.
Non-Clinical Laboratory Studies
This section must give information on microbiology, immunology, biocompatibility, stress, wear, shelf life, and other laboratory or animal tests. The FDA provides manufacturers guidance in how to conduct these appropriate studies.
Clinical Investigations
This section must include details about how the studies were conducted, data about safety and effectiveness of the device, any adverse reactions and complications, failures and replacements of the device. This section also has information about patients, including complaints, data tabulations from all individual study subjects, and statistical analysis results.
The PMA Submission Process
The PMA Submission Process begins once the applicant submits their final and complete application to the FDA, including the results of all necessary laboratory studies and clinical investigations. Once the agency begins their initial review stage, they may ask the applicant for additional information to include with an application. Applicants will have a short window of time to provide this additional information, and if they are not able to provide the information requested by the deadline, the application will be considered withdrawn. If the company wants to move forward with the application following its’ withdrawal, it must fully restart the submission process.
Once the application is in review, the agency should provide action within 180 days. It is important to note application review times may vary depending on the current number of applications under agency review, and can commonly exceed 180 days. Applicants should be prepared in the case they do not recieve a decision within the typical 180-day period.
Your PMA Submission Team
Are you looking to bring your Class III medical device to the US market through the PMA submission pathway? Our team is here to help. At Accorto, we specialize in assisting companies in navigating the complex regulatory landscape to bring their FDA-regulated products to market quickly and efficiently.
Industry
Experts
Backed by decades of experience with the FDA across a range of regulated sectors, our team brings an unparalleled depth of knowledge and expertise to your PMA submission.
Custom Tailored Solutions
We recognize the unique needs of each application, which is why we customize our approach to fit our client’s individual project needs, budget, and timeline. Our personalized strategies ensure you receive top-tier regulatory services without compromising on your specific goals and resources.
Accelerate Your To-Market Timeline
We understand time-to-market can critically impact market success for our clients. With our streamlined processes, you’ll experience a faster journey from submission to approval, giving you a competitive advantage.
Turnkey PMA Submission Solutions
Let us take the complexity out of PMA submissions. Our team has decades of experience navigating the intricate FDA medical device regulatory landscape, allowing us to seamlessly guide your product through the appropriate pathway toward market acceptance. From strategy development to application submission, we’re your partners in securing swift approvals and market leadership.
Our PMA Solutions Include:
The Right Resources.
The Right Time.
When you choose Accorto for your PMA submission, you not only gain access to our in-house team of industry experts and technical writers but also our global network of industry partners who are on-call and ready to complete your project’s requirements. From design houses, to contract manufacturers, to clinical research organizations (CRO’s), we have access to the resources you need to achieve success.
All organizations in our network have been hand-selected for their specialized knowledge, state-of-the-art facilities, and track record of delivering exceptional results and our network is constantly expanding, allowing us to keep pace with industry advancements and deliver cutting-edge solutions for our client’s unique projects.
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