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Expert PMA Consultants for High-Risk Class III FDA Approvals
Getting FDA approval through the Premarket Approval (PMA) pathway is rigorous, but with the right expertise, it becomes a strategic advantage. Elexes' experienced PMA consultants help you navigate clinical evidence, regulatory submissions, and technical documentation to ensure your Class III device gets to market faster and stronger.
What is FDA PMA and When is it Required?
Premarket Approval (PMA) is the FDA’s most stringent regulatory process for medical devices. It applies primarily to Class III devices, those that support or sustain life, are implanted, or present a high risk of illness or injury. Unlike the 510(k) process, which demonstrates substantial equivalence to an existing device, PMA requires independent scientific evidence of safety and effectiveness, often including clinical data, nonclinical testing, and detailed manufacturing and labeling information.
PMA Is Required for High-Risk Class III Devices
Devices classified under Class III per 21 CFR 860.3(c)(3) are typically subject to PMA requirements. These include:
⦿ Implantable devices (e.g., pacemakers, breast implants)
⦿ Life-supporting devices (e.g., mechanical heart valves)
⦿ Life-sustaining devices (e.g., ventricular assist devices)
⦿ Certain in vitro diagnostic (IVD) tests (e.g., HIV diagnostics, genetic cancer risk tests)
Full-Service PMA Submission Support from Elexes
Experienced Premarket Approval Consultants help:
⦿ Determine whether PMA is required or if a De novo or 510(k) route is possible
⦿ Design compliant clinical and nonclinical test plans
⦿ Prepare robust PMA submissions in FDA-compliant structure
⦿ Lead pre-submission meetings and correspondence with FDA
⦿ Respond to additional information (AI) requests and panel recommendations
Scientific Evidence is the Core of PMA
Unlike 510(k), where you compare your device to a predicate, PMA submissions must include independent evidence to demonstrate a device’s safety and effectiveness. This includes:
⦿ Clinical trials under an Investigational Device Exemption (IDE), when applicable
⦿ Nonclinical bench and animal testing (e.g., biocompatibility, electrical safety, mechanical testing)
⦿ Sterilization validation and shelf-life studies
⦿ Human factors engineering and usability studies
⦿ Labeling that meets FDA content and format requirements
When do you need PMA consultants?
You need expert PMA consultants when:
⦿ You're developing a Class III medical device without a predicate
⦿ Your device includes new technology or materials that lack safety data
⦿ You need to conduct clinical trials or submit an Investigational Device Exemption (IDE)
⦿ You’re unsure about the appropriate PMA pathway (traditional vs modular vs expedited)
⦿ You need guidance on responding to the FDA’s questions or deficiency letters
Engaging regulatory experts early helps prevent delays, missed expectations, and costly redesigns. Elexes helps you proactively anticipate FDA requirements and deliver a robust submission package.
Full-Service Support for PMA Submissions
Deep regulatory expertise and cross-functional experience
⦿ In-depth understanding of PMA requirements across diverse therapeutic areas, including cardiology, orthopedics, neurology, and IVDs.
⦿ Expertise in Investigational Device Exemption (IDE) submissions, clinical study designs, and the FDA’s expectations for scientific evidence.
⦿ Familiarity with expedited PMA programs such as Priority Review and Humanitarian Device Exemption (HDE), when applicable.
Robust submission preparation and strategic communication
⦿ End-to-end support for PMA documentation, including technical files, clinical trial reports, manufacturing processes, and quality systems.
⦿ Hands-on experience with FDA eCopy formatting, modular PMA submissions, and well-organized labeling and risk documentation.
⦿ Direct liaison with FDA reviewers, including preparation for pre-submission meetings, panel interactions, and deficiency letter responses.
Proven results and long-term regulatory support
⦿ Track record of successful PMA supplements and amendments (panel-track, 180-day, real-time, special).
⦿ Support beyond approval, including post-approval studies, annual reports, and change control documentation.
⦿ Long-term partnership model to guide your future innovations through the regulatory lifecycle.
Our Services
Our Compliance Assessment Process
Our process begins with an in-depth consultation where we learn about your medical device, its intended use, and your specific goals. This helps us tailor our assessment to your unique needs.
Our team of experts is well-versed in global medical device regulations, including FDA submissions, CE marking, TGA requirement, Health Canada approvals, ISO, and more. We stay up-to-date with the latest changes in the regulatory landscape.
We will conduct a comprehensive review of your existing documentation, including design files, clinical data, quality management systems, and risk assessments.
Our consultants will perform a gap analysis to identify any areas where your device may fall short of compliance. This forms the basis for our recommendations.
Based on our findings, we will provide you with detailed recommendations and a roadmap for achieving compliance. This may involve revising documentation, conducting additional testing, or making necessary design changes.
Our services don't stop with just the assessment. We offer ongoing support to guide you through the compliance process, helping you address any challenges that may arise.
Why Partner with Elexes PMA Consultants?
Our team of PMA consultants works collaboratively with yours, not just to reach approval, but to build sustainable regulatory success.
Whether you’re in the concept phase or preparing for FDA review, Elexes' expert PMA consultants will ensure your high-risk medical device meets all regulatory expectations. Partner with us to avoid pitfalls, accelerate timelines, and gain FDA approval with confidence.
Let’s build a PMA Strategy That Works!
Click here to explore our full-service PMA consulting for medical devices.
PMA in Perspective: How It Stands Apart and What the Journey Looks Like
Understanding where PMA stands among other FDA pathways is essential before diving into its intricate submission process. Here’s a side-by-side comparison of PMA, De Novo, and 510(k) submissions to help you choose the right path, along with a clear timeline of the PMA process, from preparation to FDA decision, so you know what to expect at each stage.
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Experience timely results with our efficient services.
Confidentiality guaranteed
We offer 100% confidentiality understanding how critical the data is for you.
Elexes offer complete range of regulatory and compliance expertise, ensuring full-support in product development and post-market compliance. Get everything under one roof for your medical device!
So, if you are looking for a consultancy with deep expertise, experience, and established relationships with regulatory authorities, which can significantly enhance a company's regulatory journey and increase the likelihood of successful product registration and market access, all you have to do is
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Tom Birney
CEO Masterlink, Arizona
“
Elexes gave us immense support. Their Knowledge and thoroughness were excellent. I look for all of these qualities in consulting firms
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Diane Bryant
CEO Novasignal, Los Angeles
“Prompt and competent! Elexes should be your next regulatory consultant. Their timeline-based project plan expedited the process.
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Daniel Kinsey
President ViDava, Florida
“Professional and easy to work with! They expedited CE Marking for our products and also created clinical evaluations, risk assessments, and provided testing/manufacturing advice.
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Linda Pan
Sr. Exe Treedental, Hong Kong
“Having Elexes as our import-export expert was a great choice. Elexes' team answered all our questions and guided us through every step.
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Joshua Mink
Manager Outset Medical, California
“Highly recommend Elexes! They always meet commitments and follow through on action items.
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Michal Depa
CTO Jana Care, Massachusetts
“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product's nuances quickly.
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Philip McFerran
MD Blackrock Pharma, England
“Kudos to the Elexes team! They're always proactive and have provided invaluable support to us with import, labels, and registrations.
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Samip Shah
VP Regulatory AliveCor, California
“Excellent communication, diligent work. There is a strong quality background and QMS norms expertise.
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Elizabeth W
Owner Liz Inc., Arizona
“Accurate and amazing! Their regulatory-compliant fact sheets for multiple products enabled us to sell domestically and internationally without issues. Their work had an impressive turnaround time.
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Kurt Sysock
CEO Radformation, New York
“Elexes is a go-to for all FDA regulatory and quality systems work. They outperformed every expectation!
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