In case you haven’t heard…
The FDA has issued warning letters to two Chinese firms regarding data quality and integrity concerns. The agency is particularly concerned about the reliability of data used in medical device submissions. As a result, the FDA will not authorize submissions where the data is necessary for approval. Additionally, the FDA is reviewing past submissions for potential impact.
The key takeaways are:
Device firms are ultimately responsible for the integrity of all data submitted to the FDA, even if it’s generated by a third-party testing lab.
FDA does not intend to authorize submissions where the data [from these two sites] are necessary for the FDA to make a marketing authorization decision.
Please share this information with any potentially impacted companies.
Primary Source:
Links found in the article:
- Mid-Link Testing Company, Ltd – 687111 – 09/10/2024 | FDA
- Sanitation & Environmental Technology Institute dba SDWH – 687970 – 09/10/2024 | FDA
- Fraudulent and Unreliable Laboratory Testing Data in Premarket Submissions: FDA Reminds Medical Device Manufacturers to Scrutinize Third-Party-Generated Data | FDA