FDA Cites California Firm for Class II Device’s Design History File

The FDA hit Santa Barbara device specification developer Dental Engineering Laboratories with a Form 483 for failing to maintain a design history file.

The firm lacked a design history file for its Terauchi File Retrieval Kit, a device used to take out broken endodontic file segments from a tooth’s root canal.

Specifically, the firm had no record of design inputs, outputs, verification, validation, reviews and transfer of the design into production of the device. The product has been on the market since 2016, the agency said.