Medical Device Approval Primer

Medical Device Approval Primer takes a close look at the complex world of regulatory approval pathways. With a focus on the FDA and EMA agencies, it identifies the regulatory compliance requirements and different medical device classifications, from Class I to III, that are critical to ensuring patient safety. This primer provides insight into the FDA and EMA organizational structure and approval pathways, such as 510(k), De Novo 510(k), PMN, and PMA. Learn about the importance of Quality System Regulations (QSR) requirements, Good Laboratory Practices (GLP), and Good Clinical Practices (GCP) used worldwide in medical device development. Become fluent in assessing risk and choosing the appropriate medical device approval pathway―grab your seat today!

Section 1: Medical Device Overview

Explore medical device sectors, regulatory history, and classification based on risk assessment.

Section 2: Medical Device Regulation

Discusses the medical device approval pathways; compliance laws like Code of Federal Regulations, Good Lab Practices, Good Clinical Practices, and current Good Manufacturing; risk management planning, and provides insight into global regulatory bodies.

Five Takeaways


  1. Identify the medical device industry’s major device sectors and worldwide regulatory organizations.
  2. Classify medical devices based on potential risks.
  3. Explain the major medical device approval pathways.
  4. Discuss how the Code of Federal Regulations and Good Practices enforces regulatory compliance.
  5. Develop a risk management plan for a medical device.

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