The required document checklist for FDA certification application of medical devices typically includes the following items:
Device Description: A detailed description of the device, including its intended use and indications for use.
Classification Information: Information on the classification of the device (Class I, II, or III) and applicable regulatory pathway (510(k), PMA, etc.).
Performance Data:
Labeling Information:
Quality Management System (QMS) Documentation: Evidence of compliance with relevant QMS standards (e.g., ISO 13485), including:
Risk Management Documentation: A risk management plan and report, following ISO 14971 guidelines, detailing risk analysis and mitigation strategies.
Biocompatibility Data: For devices in contact with the body, documentation of biocompatibility testing based on ISO 10993 standards.
Sterilization and Shelf Life Data: Information on the sterilization methods used and validation of shelf life if applicable.
Manufacturing Information:
Clinical Study Protocols: If applicable, protocols for any clinical studies conducted to support the device's safety and effectiveness.
User Information: Materials that will be provided to users, including training materials, if applicable.
Environmental Impact Information: If applicable, documentation regarding the environmental impact of the device.
Financial Disclosure Information: Required if clinical studies are involved, detailing any financial interests related to the study.
Submission Forms: Completed forms specific to the type of submission (e.g., 510(k) summary or PMA application form).
By compiling these documents, you can ensure a comprehensive and organized submission for FDA certification of your medical device.
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