Securing FDA premarket approval (PMA) is a rigorous process required for Class III medical devices that support or sustain human life or prevent impairment. At Elexes, we specialize in guiding medical device companies through this complex regulatory path with precision and clarity.
From determining the regulatory strategy to preparing robust scientific and clinical evidence, we help reduce delays and ensure your PMA application meets the FDA’s high standards.
Partner with Elexes for:
⦿ Strategy and gap analysis
⦿ Clinical data review and protocol planning
⦿ FDA interactions and advisory meeting support
⦿ Complete PMA documentation and eCopy preparation
Let’s simplify your PMA journey.
Elexes brings years of regulatory expertise and clinical insight to every project. We don’t just consult, we collaborate. Our experienced FDA PMA consultants are well-versed in the complexities of design controls, clinical research, and FDA regulatory requirements, helping your Class III device PMA submission move confidently toward approval.
We’ve supported medical device companies globally in obtaining PMA for advanced technologies such as implantable systems, drug-device combinations, and beyond.
Our strengths:
⦿ Deep knowledge of FDA 21 CFR Part 814
⦿ Tailored regulatory roadmaps
⦿ Multi-disciplinary team of engineers, clinicians, and regulatory experts
⦿ Proven track record of successful PMA outcomes
Essentials of a Successful PMA:
⦿ Determination of device classification and applicable regulations
⦿ Submission of an Investigational Device Exemption (IDE), if needed
⦿ Well-documented design controls and risk management files
⦿ Comprehensive clinical investigation data demonstrating safety and effectiveness
⦿ Thorough non-clinical bench testing and biocompatibility reports
⦿ Completed manufacturing information (process validation, quality system compliance)
⦿ Clear and complete labeling, instructions for use, and promotional material
⦿ Robust statistical analysis and justification
⦿ Submission of an FDA-ready eCopy
Explore how we support FDA 510(k) submissions for devices that follow different approval pathways.
We begin with a comprehensive review of your device’s design and intended use. This helps us determine if PMA is the correct regulatory path and whether a modular submission or traditional PMA is more suitable.
Our team evaluates your clinical evidence needs and helps design IDE protocols or retrospective studies that meet FDA requirements. We also assess bench testing, software validation, and biocompatibility to bridge any gaps.
From IDE applications to PMA modules, we prepare and review all necessary documents, ensuring they meet the strict formatting, content, and submission guidelines set by the FDA.
We help schedule and conduct Pre-Submission meetings, providing briefing documents and coaching for sponsor presentations. This proactive engagement ensures a smooth review cycle.
After PMA approval, we continue supporting your company with periodic reports, manufacturing changes, post-market surveillance, and regulatory notifications.
Explore the structured process and how Elexes partners with you from start to finish.
Let Elexes guide your FDA premarket approval, strategically, efficiently, and with compliance at every step.
FDA PMA Submission Checklist for Medical Device Companies:
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FDA Premarket Approval (PMA) is the regulatory process for evaluating Class III medical devices that support or sustain human life or pose significant risk. PMA requires scientific and clinical evidence to demonstrate safety and effectiveness.
FDA PMA review typically takes 180 days or more. The timeline can vary based on the complexity of the device, completeness of the application, and whether panel review is needed.
Yes, PMA submissions generally require clinical data to demonstrate safety and effectiveness. IDE studies may be needed for investigational use within the U.S.
Elexes offers a globally recognized ISO 13485 certification consultant who is renowned to enhancing your business credibility in the medical devices industry.
Our presence across the globe ensures audits are conducted by local-language auditors, facilitating clear communication and understanding.
Our experts provide guidance and consultants to help you adhere to necessary regulations, ensuring your products meet all legal requirements and is compliant to all necessary standards.
At Elexes, we offer to assist in securing additional local certifications, enabling you to manufacture and sell medical devices in various markets across the globe.
We offer complete confidentiality to all our clients which makes us one of the most trusted regulatory and quality compliance consulting.
We offer different services that will help you not only keep your product well in boundaries of regulations but also speed up the entire approval process. Some of these services are -
CEO Masterlink, Arizona
CEO Novasignal, Los Angeles
President ViDava, Florida
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VP Regulatory AliveCor, California
Owner Liz Inc., Arizona
CEO Radformation, New York
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