Sol-Millennium Medical, Inc.

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 establish and maintain procedures for the identification, documentation, validation, or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i).

Passage 2

Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). Specifically,

Passage 3

Failure to maintain adequate records of the investigation by the formally designated unit identified in 21 CFR 820.198(a) when an investigation is made, as required by 21 CFR 820.198(e).

Passage 4

Failure to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17.

Passage 5

Failure to submit a report to FDA 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 your firm markets has malfunctioned and this device or a similar device that it 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). For example,