Guidance For The Content Of Premarket Notifications For Esophageal And Tracheal Prostheses - Guidance For Industry

Description

U.S. Department Of Health And Human ServicesFood and Drug AdministrationCenter for Devices and Radiological Health

Scope & Applicability

Regulatory Context

• 21CFR20.61§ 20.61 Trade secrets and commercial or financial information which is privileged or confidential.

  (a) A trade secret may consist of any commercially valuable plan, formula, process, or device that is used for the making, preparing, compounding, or processing of trade commodities and that can be said to be the end product of either innovation or substantial effort. There must be a direct relationRead full regulation →

• 21CFR807.87§ 807.87 Information required in a premarket notification submission.

  Each premarket notification submission shall contain the following information:Read full regulation →

• 21CFR878.3720§ 878.3720 Tracheal prosthesis.

  (a) Identification. The tracheal prosthesis is a rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or tRead full regulation →

• 21CFR878.3610§ 878.3610 Esophageal prosthesis.

  (a) Identification. An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the esophagus. The metal esophageal prosthesis may be uncovered or covered withRead full regulation →

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