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FDA title 21 of US CFR

FDA title 21 of US CFR

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Engineering High Quality Medical Software: Regulations, standards, methodologies and tools for certification — Recommend this title to your library

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In accordance with its mission, “The Food and Drug Administration (FDA) in the USA is responsible for protecting public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, food supply, cosmetics, and products that emit radiation.” The FDA is also responsible for advancing public health by helping to speed up the progress of innovations that make medicines more effective, safer, and more affordable and by helping the public to obtain the accurate, science-based information they need to use medicines and foods to maintain and improve their health. The FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. Finally, the FDA plays a significant role in the national counter-terrorism capability. It fulfills this responsibility by ensuring the security of the food supply and by fostering the development of medical products to respond to deliberate and naturally emerging public health threats.

Chapter Contents:

  • 3.1 The role of the Food and Drug Administration
  • 3.2 Content of the Codes of Federal Regulation 21 CFR
  • 3.3 The approval process for Software as a Medical Device
  • 3.3.1 Qualification
  • 3.3.2 Classification
  • 3.3.3 Implementation of a quality management system
  • 3.3.3.1 Management responsibility
  • 3.3.3.2 Quality audit
  • 3.3.3.3 Personnel
  • 3.3.4 Documenting the Software as a Medical Device
  • 3.3.5 FDA clearance and premarket approval

Inspec keywords: occupational safety; occupational health; legislation; biological effects of radiation

Other keywords: medical devices; cosmetics; biological products; public health protection; Food and Drug Administration; national counter-terrorism capability; veterinary drugs; US CFR; Code of Federal Regulations; FDA title 21; tobacco products; science-based information; human security; public health threats; food supply

Subjects: Health and safety aspects; Legal aspects

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