Insung Medical Co. Ltd.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Failure to report the information required by § 803.52 in accordance with the requirements of § 803.12(a), no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that it markets has malfunctioned and this device or a similar device that your firm markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR 803.50(a)(2).

Passage 2

Failure to adequately develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17(a). For example, during the inspection, your firm presented a document “Medical Device Reporting Procedure (MDR)”, Document No.: MDR‐001~MDR‐003, Rev. 0, dated 2025‐01‐08, as its written MDR procedure. After reviewing the procedure, the following deficiencies were noted: