MedApex Research will be responsible for FDA regulatory activities and documentation such as:
● Regulatory Submissions: Prepare and submit required regulatory documentation and subsequent annual progress reports.
● Ongoing regulatory guidance to ensure compliance with FDA guidelines.
● FDA Communication: Act as the liaison between the sponsor and the FDA, providing regular updates and responding to FDA inquiries, especially during safety evaluations or protocol amendments. Serving as the primary point of contact with the FDA, managing all communications, submissions, and responses related to the trial and approval process, always working in alignment with the sponsor.
● Final Reporting and Approval - Prepare the Clinical Study Report (CSR), summarizing all data, including safety, efficacy, and risk/benefit analysis.
● Audits and Inspections: Prepare trial sites for FDA inspections and internal audits. Respond to audit findings, providing corrective actions and maintaining regulatory compliance.
● Post-Market SurveillancePost-Market Surveillance and Compliance : Conduct post-market surveillance studies as required for devices approved through the PMA process or for high-risk devices, ensuring the device continues to perform safely and effectively in the real world.
● Medical Device Regulatory Submissions and Interactions:
■ (510(k) Submissions): For Class II devices, prepare and submit substantial equivalence documentation to the FDA as part of the 510(k) process.
■ PMA Submissions: For Class III devices, compile and submit detailed safety and efficacy data to the FDA as part of the PMA process. This includes preclinical and clinical data, manufacturing processes, and labeling.
■ Regulatory Filing: Submit the final regulatory filing for 510(k), PMA, or De Novo classification, ensuring that the submission meets FDA formatting and content requirements.
■ Medical Device Reporting (MDR): Ensure that any adverse events, malfunctions, or product defects are reported in compliance with FDA.