Koven Technologies, 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 document procedures to control design and development changes, and determine the significance of these changes to function, performance, usability, safety and regulatory requirements for the medical device and its intended use, as required by ISO 13485:2016 Clause 7.3.9.

Passage 2

Failure to document one or more processes for risk management in product realization and determine, as appropriate, quality objectives and requirements for the product, as required by ISO 13485:2016 Clause 7.1.

Passage 3

Failure to establish criteria for the evaluation and selection of suppliers, as required by ISO 13485:2016 Clause 7.4.1.

Passage 4

Failure to maintain records of the review, evaluation, and investigation for any complaints involving the possible failure of a device, labeling, or packaging to meet any of its specifications, as required by 21 CFR 820.35(a).