A company wants to destroy records of an earlier version of a device. What is the correct course of action?

In the context of regulatory affairs, particularly regarding the destruction of records for medical devices, it is vital to understand the regulatory requirements and the importance of maintaining certain records for compliance, traceability, and safety reasons.

The assertion that no records can be destroyed is correct because regulatory compliance often dictates that manufacturers retain specific records for a designated period, even after a device has been discontinued or replaced by a newer version. This includes a variety of documents, such as design history files, manufacturing records, and quality management system documentation. These records are essential for maintaining accountability and ensuring product safety, as they may be needed for audits, inspections, or in response to adverse events associated with the product.

Furthermore, regulations often specify the length of time that certain records must be retained, which can extend for years, depending on the type of device and the applicable laws in the jurisdiction. For instance, the FDA requires that records related to medical devices are kept for a minimum of 2 years after the last distribution of the device. Therefore, simply deciding to destroy records can lead to significant legal and regulatory repercussions.

Overall, understanding the implications of record retention is crucial for companies in the medical device industry to uphold their regulatory obligations and ensure the safety and welfare of the users