§ 5.400 - Issuance of Federal Register documents to recognize or to withdraw recognition of a standard to meet premarket submission requirements.

§ 5.401 - Issuance of Federal Register documents pertaining to exemptions from premarket notification.

§ 5.402 - Detention of adulterated or misbranded medical devices.

§ 5.403 - Authorization to use alternative evidence for determination of the effectiveness of medical devices.

§ 5.404 - Notification to petitioners of determinations made on petitions for reclassification of medical devices.

§ 5.405 - Determination of classification of devices.

§ 5.406 - Notification to sponsors of deficiencies in petitions for reclassification of medical devices.

§ 5.407 - Approval, disapproval, or withdrawal of approval of product development protocols and applications for premarket approval for medical devices.

§ 5.408 - Determinations concerning the type of valid scientific evidence submitted in a premarket approval application.

§ 5.409 - Determinations that medical devices present unreasonable risk of substantial harm.

§ 5.410 - Orders to repair or replace, or make refunds for, medical devices.

§ 5.411 - Medical device recall authority.

§ 5.412 - Temporary suspension of a medical device application.

§ 5.413 - Approval, disapproval, or withdrawal of approval of applications and entering into agreements for investigational device exemptions.

§ 5.414 - Postmarket surveillance.

§ 5.415 - Authority relating to medical device reporting procedures.

§ 5.416 - Medical device tracking.

§ 5.417 - Authority pertaining to accreditation functions for medical devices.