FDA Premarket Approval (PMA) Submission Services

FDA Premarket Approval (PMA) Submission Services Get rapid access to the industry's best PMA consultants and move your product to market.

Navigating the Premarket Approval (PMA) process is a complex and time-intensive process, crucial for assuring the safety and effectiveness of high-risk medical devices before their market release. At The FDA Group, we're acutely aware of the intricacies involved in the PMA journey and are dedicated to guiding your path through it. Our former FDA professionals will help you get your medical device to market and keep it there.

Our regulatory affairs specialists are equipped to assist you at every stage of the PMA process, from meticulous data collection and submission to conducting clinical trials and managing interactions with the FDA. We recognize the importance of launching your device swiftly and proficiently, which is why we collaborate closely with you—ensuring your submission is thorough, precise, and in full compliance with all FDA requirements.

Experienced PMA consultants

Unlike other regulatory consulting firms, our consultants are highly seasoned professionals with a proven track record of success in supporting marketing applications, including NDAs, BLAs, ANDAs, 510(k)s, PMAs, etc. Make sure you receive the depth of knowledge and expertise needed to navigate the complex PMA process effectively. We pride ourselves on delivering top-tier regulatory specialists quickly and more cost-effectively than traditional firms.

Industry and former FDA professionals

Our consulting network includes a diverse group of regulatory professionals, among them former FDA personnel with firsthand experience with product approval. Their unique insights into the FDA's review process and expectations equip us to manage our clients' submissions with unparalleled expertise and precision. This insider perspective, combined with our decades of collective experience, gives us the edge to help our clients navigate the complex PMA submission process.

Unparalleled client success and satisfaction

Our 95% client success rate (first resource, first time) and 97% client satisfaction rate speak for themselves. Our clients trust in our expertise to guide them through the submission process. With us as your consulting partner, you'll get a refreshingly personalized approach, clear communication, and attention to detail — three elements that are becoming increasingly hard to find. It's what makes us the preferred choice for PMA and other marketing application support services.

Why you need an expert PMA consultant

Premarket Approval represents the FDA's rigorous and comprehensive review process, designed to assess the safety and effectiveness of Class III medical devices. Given the high stakes involved, the FDA has determined that mere general and special controls are inadequate to guarantee these devices' safety and effectiveness.

PMA stands as the most exacting form of device marketing application mandated by the FDA. Before these products can enter the US market, applicants must secure FDA approval for their PMA application. A skilled medical device regulatory consultant is vital for guiding you through the PMA process. Our consultants ensure you smoothly navigate through this complex path, deeply understand your device, and foresee potential challenges.

Over the many years we've spent helping device firms gain Premarket Approval, we've seen companies realize they need expert help in a number of areas, including but not limited to the following:

Regulatory Strategy for Marketing Approval: Developing a robust regulatory strategy that aligns with marketing goals is critical. This includes understanding FDA requirements for marketing a medical device, identifying the appropriate regulatory pathway, and planning for potential regulatory challenges.

Clinical Data and Evidence Presentation: Clinical data is a cornerstone of the PMA process. Our regulatory consultants help in effectively presenting clinical trial data to demonstrate the safety and effectiveness of the device. This involves statistical analysis, interpretation of clinical study results, and preparation of comprehensive summaries for the FDA.

Labeling and Promotional Material Review: Accurate and compliant labeling and promotional materials are essential for marketing. Our consultants review and advise on labeling, advertising, and promotional materials to ensure they meet regulatory standards and accurately represent the device.

Technical Documentation and Submission Preparation: Preparing the PMA submission requires comprehensive technical documentation. Our consultants aid in compiling, reviewing, and organizing the necessary documents, including preclinical and clinical data, to meet the stringent requirements of the FDA.

Quality Systems and Good Manufacturing Practices (GMP): Compliance with Quality System Regulations (QSR) and GMP is essential. We routinely help in setting up and auditing quality systems, ensuring that the manufacturing process meets all regulatory standards.

Compliance with Post-Market Requirements: Post-market surveillance and reporting are crucial even after the marketing phase begins. Our consultants can guide the implementation of systems for monitoring the device's performance in the market and reporting any adverse events or other required data to the FDA.

PMA Marketing Application Support Services

A skilled device consultant is vital for guiding you through the PMA process. Our consultants ensure smooth navigation through this complex path, deeply understanding your device and foreseeing potential challenges.

Each PMA consulting engagement is custom-tailored to your needs and may include, but is not limited to:

Regulatory strategy development

Creating a comprehensive regulatory strategy that aligns with your device and FDA requirements.

Preparation of PMA submissions

Writing and compiling the PMA submission.

Interaction with the FDA

Facilitating communication with the FDA, including responding to agency queries and additional information requests.

Post-approval support

Offering continuous regulatory support for post-approval modifications, periodic reporting, and maintenance of device marketing approval.

Post-clearance support

Providing ongoing regulatory support for post-approval changes, periodic reporting, and maintenance of device marketing clearance.

Case Study Guiding 510(k) Preparation and Submission for U.S. Medical Device Market Clearance

Learn how The FDA Group supported a European biomedical sensor company’s
FDA premarket notification via the 510(k) pathway by redirecting its regulatory strategy to the optimal market clearance pathway, providing expert guidance to a small in-house regulatory team, and engaging with regulators.

Let's bring your product to market and keep it there.

Contact us today to take the first step toward bringing your product to market quickly and efficiently. A flawed submission will cause delays and hold up your product launch for several months—perhaps longer.

Our regulatory affairs consultants will give you individualized support to maximize the likelihood that your submission is successful and delay-free. Our bench of regulatory affairs talent has extensive experience and knowledge, with some having worked directly with and within FDA. They will share their expertise with you throughout the review process, providing a level of service and professionalism that's hard to find elsewhere.

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