SOCRA CCRP Practice Exam

How many days does a sponsor have to submit a report on returns, repairs, or disposal of units of a device?

1. Within 15 days after the request

2. Notice to be provided within 30 days after request was made

3. Immediately without undue delay

4. Within 90 days for full compliance

The correct answer is: Notice to be provided within 30 days after request was made

The correct answer is based on regulatory requirements that dictate timeframes for sponsors to report on the returns, repairs, or disposal of units of a device. The stipulation is that a sponsor must provide notice within 30 days after a request was made. This requirement ensures that sponsors are held accountable for tracking device experiences, which is critical for safety monitoring and the appropriate management of product integrity in the market. The option indicating immediate reporting without undue delay, while seemingly beneficial, lacks the specificity necessary for tracking and regulatory compliance. Meanwhile, options suggesting a longer timeframe, such as 90 days, do not reflect the urgency that is often necessary in the context of device safety reporting. Understanding these parameters is crucial for compliance timelines, risk management, and ensuring the continued efficacy and safety of medical devices post-market.