Biosensors Interventional Technologies Pte Ltd – FDA Warning Letter, Apr 20, 2023

The FDA issued a Warning Letter to a Singapore-based medical device manufacturer of the BioFreedom Drug Coated System following an inspection from April 17-20, 2023. The inspection revealed the device is misbranded under 21 U.S.C. § 352(t)(2) due to failures in Medical Device Reporting (MDR) and adulterated under 21 U.S.C. § 351(h) for non-conformity with Quality System (QS) regulations (21 CFR Part 820).

Key violations include: 1. **MDR Procedures (21 CFR 803.17(a)(1)):** Failure to adequately develop, maintain, and implement written MDR procedures. The firm's procedures combine requirements from other authorities, potentially leading to incomplete or inadequate reporting. The firm also lacks an active Electronic Submissions Gateway (ESG) production account for eMDR submissions. 2. **Failure to Submit MDR for Serious Injury (21 CFR 803.50(a)(1)):** Failure to report a serious injury (acute stent thrombosis requiring intervention) for complaint CB22-10-004 within 30 days of awareness (October 14, 2022). 3. **Failure to Submit MDR for Malfunction (21 CFR 803.5