§7.7. Quality assurance. — Inbound Citations

(1) Each application for original approval, subsequent approval, or extension of approval of a product shall include a certification by the applicant that the product meets the design portion of the technical requirements, as specified in the appropriate subpart, and that the applicant will perform the quality assurance functions specified in § 7.7. For a subsequent approval or extension of approval, the applicant shall also certify that the proposed change cited in the application is the only change that affects the technical requirements.