Learn how to prepare and submit a Premarket Approval (PMA) application for high-risk medical devices. Follow our step-by-step guide to ensure compliance with FDA requirements and streamline your regulatory process.
Obtaining regulatory approval for a medical device through a Premarket Approval (PMA) application is long and arduous. Yet, navigating the PMA process is possible if you do your good share of planning and research. This article will guide you through the main stages of preparing and filing a PMA with the regulatory agencies.
Step 1: Know the Regulatory Landscape:
Before you even start the PMA process, it is important that you are aware of the regulatory policies in place in a country or region where your medical device is intended for marketing. Make sure to research the regulatory agency that is tasked with approving devices (FDA in the U.S.) and get yourself more than familiar.
Step 2: Consider PMA applicability:
Assess whether your medical device is a PMA. PMAs are generally for high-risk devices (largely novel), e.g., implantable devices or life support/sustaining devices. Class I and moderate-risk Class II devices are required to comply with other regulatory pathways, such as the 510(k) clearance process.
Step 3: Form a Cross-Functional Team
Bring together a team with expertise across several disciplines, such as regulatory affairs, engineering, quality assurance and clinical research. This is the team that will oversee and operationalize the PMA submission.
Step 4: Regulatory Strategy Development:
Develop an all-encompassing regulatory strategy, detailing the pathway to be followed in PMA process. Besides real-world experience and relationships, getting a product on the shelves requires planning which should ideally include a detailed timeline with key milestones and regulatory pathway consolidations specific to your device. Incorporate regulatory guidelines and standards in your strategy.
Step 5: Collect and analyze preclinical data:
Generate laboratory testing, animal studies or other appropriate methods for preclinical data. This data should also demonstrate the safety and efficacy of your medical device. You will eventually compile the results and analyze them to ensure that they comply with the regulations established by the agency.
Step 6 Clinical Trial Initiation:
If clinical data is needed as part of the PMA submission, you must design and conduct successful clinical trials consistent with GCP Guidelines. These trials need to be well-designed in order for your device to demonstrate relative safety and effectiveness. Respect ethical considerations and meet patient consent requirements.
Step 7: Assemble the PMA Application:
Pull together all required documents, and to support the PMA. There are detailed specs on the device, its manufacturing flow, preclinical and clinical data, labeling, IFU and risk assessments. Make sure that the data is traceable to source documents and information is accurate, complete, and organized per regulatory requirements.
Step 8: Perform an In-Depth Quality Review Before submission:
Review through internal quality assurance to ensure that all sections of PMA application comply with regulatory standards. This review includes both the technical content and the format of submission.
Step 9: File the PMA Application:
Follow the filing instructions provided by the regulatory agency. Follow the agency request for submission of PMA application in electronic or hard copy form. Deadlines: Be aware of the deadlines for all forms along with fees, and documentation that are submitted with the application.
Step 10: Respond to Agency Requests and Review Process:
After the PMA submission, regulatory agencies will evaluate whether the application is complete and scientifically valid. Be ready for any additional requests or clarifications back from you to answer quickly. Maintain an ongoing conversation with the agency to discuss any questions or concerns that might come up throughout the case review.
Conclusion
Uploading a PMA is an important step in being able to market high-risk medical devices. This step-by-step guide and cross-functional team will lead the way for you to confidently travel through this intricate process. Keep up to date with current regulatory standards and keep the regulatory agency informed every step of the way during submission and review.
Get in touch with BioBoston Consulting or check out our website to learn more about how we could help with your regulatory needs.
