What is the required maintenance period for device investigation records according to FDA regulations?

What is the required maintenance period for device investigation records according to FDA regulations?

• A. One year
• B. Two years
• C. Three years
• D. Five years

Answer: (B)

According to FDA regulations, the required maintenance period for device investigation records is two years following the completion of a clinical investigation. This period ensures that all documentation related to the investigation is readily available for review, which is crucial for regulatory compliance and potential audits. The maintenance of records for this duration helps to uphold data integrity and supports the accountability of clinical investigations in the event of inquiries or compliance checks by regulatory authorities. The specified two-year timeframe strikes a balance between ensuring adequate oversight and the practicalities of record-keeping in clinical research. This is aligned with FDA's commitment to patient safety and the integrity of products entering the healthcare market.

According to FDA regulations, the required maintenance period for device investigation records is two years following the completion of a clinical investigation. This period ensures that all documentation related to the investigation is readily available for review, which is crucial for regulatory compliance and potential audits. The maintenance of records for this duration helps to uphold data integrity and supports the accountability of clinical investigations in the event of inquiries or compliance checks by regulatory authorities.

The specified two-year timeframe strikes a balance between ensuring adequate oversight and the practicalities of record-keeping in clinical research. This is aligned with FDA's commitment to patient safety and the integrity of products entering the healthcare market.