National University




MRA 603 Medical Device and Pharmaceuti

Lead Faculty: Mr. Irvin Kluth

Course Description

This course will focus on the laws and regulations, documentations and process imposed by the Federal government especially the Food and Drug Administration related to pharmaceutical and medical device approval. The course will provide students with detailed knowledge and practical application as it applies to appropriate documentation and process of approval for pharmaceutical and medical devices. The students will understand the nomenclature of the regulatory agencies; have a thorough knowledge of the code of Federal Regulations as it applies to medical devices and pharmaceutical products.

Learning Outcomes

  • Understand the Code of Federal Regulations as it applies to medical device and pharmaceutical product approval.
  • Completion of an Investigative New Drug or Investigative Device Exemption Form.
  • Complete a risk analysis grid for a drug or device.
  • Understand and submit appropriate documentation for Institutional Review Board approval.
  • Procedure and documentation for submission for approval of a new drug or device.
  • Understand the international harmonization process.
  • Understand and be able to document adverse events and recall of products.
  • Develop and implement Clinical Report Forms.
  • Have a thorough understanding of the various regulatory agencies of the Food and Drug Administration.
  • Prepare for a meeting with the Food and Drug Administration.