Learn the step-by-step Premarket Approval (PMA) process for medical device approval. Get insights on regulatory strategy, PMA submission, clinical trials, and more.
Learn how to create and send a PMA to regulatory bodies, from the important steps of the approval process.
Understanding Regulatory Requirements
The Premarket Approval (PMA) application is a critical step to determining the safety and efficacy of a medical device through regulatory approval. The process can be intricate but a step by step systematic approach and meticulous detail put you on the path to an expedited route to regulatory clearance.
1. Watch the Regulatory Landscape:
Before you even start your PMA process, it is crucial that you get a grasp of all the regulatory requirements in a country or region. Reach out to us for more details about Medical Device Registration.
In making an informed decision one thing you should not miss researching is the regulation authority that has approved a medical device, e.g., the Food and Drug Administration (FDA) in USA.
2. Identify PMA Eligibility:
Determine whether your medical device could potentially be classified as a PMA. PMAs are typically required for high-risk devices (i.e., novel implantable devices and those essential to supporting or sustaining human life).
Devices that are of lower to moderate risk may pursue alternative regulatory pathways like obtaining 510(k) clearance.
3. Entail a multi-disciplinary team
Regulatory Affairs, Engineering, Quality Assurance and Clinical Research. That team will be instrumental in coordinating and enabling the PMA submission process to be successful.
4. Craft An End-To-End Regulatory Strategy:
Put together a comprehensive strategy detailing your approach to the PMA process.
This plan should comprise a specific schedule, major milestones, and regulatory requirements just for your medical device. Another crucial aspect is the compliance with regulatory guidelines and other standards applicable to your submission.
5. Gather and assess preclinical data
Use extensive laboratory experiments, animal testing or any relevant means to confirm safety and efficacy.
Full 100% analysis of the results is required as part of due diligence to satisfy stringent regulatory standards set by the agency.
6. Applicable to PMA Submission with clinical data:
Conduct well-controlled clinical trials as required and in adherence to the principles of Good Clinical Practice (GCP) guidelines. More than these, it is essential to check for ethical and manuscript considerations and patient consent throughout the trail.
5. PMA Application:
Complete PMA application preparation, composing all relevant documents for a PMA submission such as detailed device specifications, manufacturing process, preclinical and clinical data, labeling, instructions for use and risk assessments.
In order to follow the rules and regulations compliance documentation must be made in advance and in well-defined manners.
6. Perform a Thorough Quality Assurance Review:
Perform a comprehensive internal quality assurance review to ensure that all parts of the PMA application meet regulatory requirements before submission. You should check the post about the content as well as visual making to give a final touch and also avoid any possible error.
7. Submit the PMA Application:
Electronic, paper submission of a PMA application based on guidelines provided by a regulatory agency
Make sure the application is complete, that all necessary forms and fees are included with it or in response to any inquiries by the staff of health regulation programs.
8. Participate in the Application Review Process:
Once your PMA is received, regulatory agencies will begin evaluating the application to determine if it is both complete and scientifically valid.
Stay in touch and be ready to quickly respond to any further questions or clarifications requests. A successful outcome only begins with having an early conversation with the agency.
Conclusion
Applying for a PMA to regulatory authorities is a tedious process. Hopefully, with this complete guide and a talented cross-functional team to collaborate, you will be confident about the process.
Keep abreast of the current regulatory items and be sure to communicate clearly and openly with the regulatory agency during both submission and review.
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