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(a) Applicability. (1) Current good manufacturing practice (CGMP) requirements are set forth in this quality system regulation. The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation,...
Applicability. Electrode lead wires and patient cables intended for use with a medical device shall be subject to the performance standard set forth in ยง 898.12.
(a) The regulations in this part implement section 519(e) of the Federal Food, Drug, and Cosmetic Act (the act), which provides that the Food and Drug Administration may require a manufacturer to adopt a method of tracking a class II or class III device, if the device meets one of the following...
This standard establishes human factors requirements for the acquisition and development of systems for the Federal Aviation Administration (FAA). This document presents human factors design standards that are to be applied to new, modified, or updated facilities, systems, and equipment that...
This guidance recommends that manufacturers follow human factors or usability engineering processes during the development of new medical devices, focusing specifically on the user interface, where the user interface includes all points of interaction between the product and the user(s)...
Purpose of This Change. This change transmits revised pages to Federal Aviation Administration Order JO 7340.2D, Contractions.
a. This order supports FAA Order 8000.369, Safety Management System Guidance and describes the process used to conduct SRM in the FAA. Specifically, it formalizes the use of SRM across the FAA, is focused on safety in the aerospace system, describes the specific steps when...
Preface The Aviation Maintenance Technician Handbook-Airframe (FAA-H-8083-31) is one of a series of three handbooks for persons preparing for certification as an airframe or powerplant mechanic. It is intended that this handbook provide the basic information on principles, fundamentals, and...
Preface The Aviation Maintenance Technician Handbook-Airframe (FAA-H-8083-31) is one of a series of three handbooks for persons preparing for certification as an airframe or powerplant mechanic. It is intended that this handbook provide the basic information on principles, fundamentals, and...
Purpose of This Order. This order establishes the design policy for ATCT and TRACON facilities.
Purpose of this Order. a. We've written this order to supplement RTCA/DO-254, and give you guidance for approving both simple and complex custom micro-coded components. This guidance applies to airborne systems and equipment, and the airborne electronic hardware of those systems when you work in a...
Purpose of this order.This order establishes the responsibilities for various FAA organizational elements related to the coordination of changes to International Civil Aviation Organization (ICAO) Standards and Recommended Practices (SARPs). It requires all pertinent staff offices (SOs) and...
Purpose of This Notice. This notice provides information to aviation safety inspectors (ASI) pertaining to the issuance of a letter of authorization (LOA) for commercial air tour operations for compensation or hire conducted in accordance with the provisions of Title 14 of the Code of Federal...
PURPOSE. This change transmits revised pages to Order 8710.3E Chapter 5, Conduct Practical Test/Certification Functions.
The purpose of an OCP, also known as the facility contingency plan (CP), is to reduce the impact(s) and risk(s) to the National Airspace System (NAS) in the event a facility is, or facilities are, unable to safely and efficiently provide ATC services as required by FAA Orders 7110.65, Air...
Purpose. This order rescinds previous policy memorandums on interpretation of FAR 21.50B dated August 3, 1982 and August 8, 1983, and shows aircraft/engine certification office (ACO/ECO) and aircraft evaluation group (AEG) staffs how to review and find Instructions for Continued Airworthiness (ICA)...
This Notice provides guidance regarding Threshold Crossing Height (TCH) tolerance for Category I Instrument Landing Systems.
This order provides general guidance and includes specific requirements on planning, materials, aesthetics, economics, functional requirements, future expansion capabilities, and other information necessary to provide the designer with complete guidelines for ATCT/TRACON design. PURPOSE. This order...
