![Strategies for Successful PMA Submissions A Guide for Clinical Teams]()
Premarket approval (PMA) is the regulatory pathway taken by Class III (high-risk) medical devices in the United States. It’s the most stringent regulatory pathway and requires substantial clinical data to support the safety and effectiveness claims made by a device’s manufacturer.
Given that clinical data is such a high priority for Class III medical devices, it’s important that clinical teams understand what will be required before, during, and after the PMA submission. So, in this article, we’ll break down the PMA requirements and some strategies for a successful PMA submission.
BONUS RESOURCE: Click here to download a free checklist that will streamline your processes and increase the likelihood of a successful FDA submission and market approval.
What are the PMA requirements?
FDA defines Class III medical devices as those that:
- Support or maintain a person’s life
- Have substantial importance in preventing an impairment
- Are permanently implanted in the body
- Have an otherwise unreasonable level of risk and/or fatalities
As such, these devices are subject to both general controls and premarket approval. The PMA process is meant to ensure that these devices are safe and effective for the patients that rely on them, which is why PMA submissions require substantial clinical evidence.
While the PMA process itself can potentially take as little as eight months, keep in mind that this timeline only covers the period from PMA submission to approval. There is an enormous amount of work, typically several years, that will go into the design, development, and testing of the device before the PMA application is submitted.
What are the key components of a PMA submission?
You can find the full requirements for the premarket approval application in 21 CFR Part 814.20, but the key components include:
- A description of the device’s indications for use, including a description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate and a description of the patient population for which the device is intended
- A thorough description of the device and its functional components or ingredients
- Reference to any performance standards or voluntary standards followed
- An environmental assessment in accordance with 21 CFR 25.20(n)
- The methods, facilities, and controls used for manufacturing, processing, packaging, storing, and (if appropriate) installation of the device
- A bibliography of all published reports
- A sample of the device, if practical
- Copies of all proposed labeling
- Copies of the financial certification or disclosures of the clinical investigators
Information concerning uses in pediatric patients
Particularly important for clinical teams are two additional sections known as the technical sections, which cover pre-clinical and clinical studies and must include:
- Results of nonclinical laboratory studies, which may include microbiological, toxicological, immunological, biocompatibility, stress, wear, shelf life, and other laboratory or animal tests, as appropriate.
- Results of clinical investigations involving human subjects, including information such as study protocols, safety and effectiveness data, adverse reactions and complications, device failures and replacements, patient information, patient complaints, tabulations of data from all individual subjects, results of statistical analyses, and any other information from the clinical investigations.
The technical sections will make up a large portion of your PMA application, as these include the valid scientific evidence that will support your claim that the device is safe and effective. You must also include the results of all investigations, whether adverse or supportive of your application.
I cannot stress the importance of your clinical data (and non-clinical testing data) enough. Clinical and non-clinical investigations that are not carried out in accordance with the appropriate regulations are grounds for a denial of approval.
What are some strategies for a successful PMA submission?
Given that clinical data plays such a large role in the approval or denial of your PMA application, it’s a good idea to look ahead and see what you can do to ensure that both your application and the clinical trials that precede it go smoothly. With that in mind, here are some strategies to ensure that your PMA submission ends in approval.
Engage with FDA early
FDA explicitly states that they encourage applicants to contact them before submitting their PMA application in order to get a better understanding of the agency’s regulations, requirements, guidance documents, and processes.
Communicating early and often will facilitate the process for both sides and hopefully minimize any delays in what is already a lengthy process . There are a number of opportunities to get in touch with FDA both before and during the PMA process, and these are collectively known as the Q-Submission Program:
- Pre-submissions
- Informational meetings
- Study risk determinations
- Formal early collaboration meetings
- Submission issue meetings
- Day-100 meetings for PMA applicants
Ensure high-quality study design
Your clinical data is the cornerstone of your PMA submission, potentially making or breaking your device’s approval. So it’s incredibly important to make sure that the studies which are generating your clinical data are airtight.
That means ensuring the study population is representative of the intended user population and clearly defining primary and secondary endpoints that will be clinically meaningful. It also means following Good Clinical Practice (GCP) throughout every aspect of your clinical studies, from design to adverse event reporting to data management practices.
Use compliant, MedTech-specific clinical data collection and management tools
One of the easiest ways to comply with GCP and FDA regulations around clinical data is to use an electronic data capture (EDC) solution that comes pre-validated to all of these requirements.
Attempting to do all of this with spreadsheets can lead to data errors and noncompliance with regulation like 21 CFR Part 11. And if data is not collected and managed according to FDA’s requirements, it won’t be accepted as the critical evidence you need during your PMA submission.
That’s why at Greenlight Guru, our EDC solution was built specifically for MedTech companies and comes pre-validated to ISO 14155:2020 and FDA regulatory requirements. You’ll also get 13 ready-to-use and customizable compliance document templates to ensure that your data is always collected and managed according to regulations.
BONUS RESOURCE: Click here to download a free checklist that will streamline your processes and increase the likelihood of a successful FDA submission and market approval.
Understand the PMA amendments and supplements and when to use them
It’s also a good idea to familiarize yourself with the various PMA supplements and amendments, including when you should use each of them
The PMA amendment process is particularly noteworthy here because PMA amendments are typically required when new data or analysis from a study needs to be reported to FDA. Major amendments can include:
- Significant new data from a previously unreported study
- Significant updated data from a previously reported study
- Detailed new analyses of previously submitted data
- Significant required information that was previously omitted
Keep in mind, as part of the continuing approval of a PMA, manufacturers will also be required to submit annual post-approval reports starting one year from the date of approval. The reports will identify any changes (PMA supplements), as well as reports in scientific literature concerning the device and any unpublished data from clinical and non-clinical studies related to the device.
Greenlight Guru Clinical helps you get the high-quality, compliant clinical data your PMA needs
Clinical data is at the heart of the PMA process, and it’s incredibly important that you’re able to generate, collect, and manage high-quality data in a compliant manner. That’s why we built Greenlight Guru Clinical—to ensure MedTech companies have the solution they need to help bring life-changing medical devices to market.
With compliance built into the system, Greenlight Guru Clinical offers straightforward GCP-compliant reporting and customizable forms to fit the needs of any study. It also comes with flexible access and permissions, safeguarded data management for informed consent and electronic records, real-time event progress tracking, data export, and more.
Ready to learn more about how Greenlight Guru Clinical can help you collect and manage high-quality clinical data? Contact us today for your free personalized demo →.
