RAS621

Identify of the origins and history of FDA’s responsibilities: laws and regulations.

Analyze the law and regulation decisions that have been important in establishing precedents and guiding interpretations during various stages in the life cycle of a medical device, diagnostic, or combination product.

Identify the state and federal agencies and their regulatory authority/responsibility.

Reflect on the current FDA regulatory climate and global relationships.

Identify the objectives of the EU Medical Device Regulations, including the significance of replacing directives with a regulation.

Identify recognized consensus standards and conformity assessment program to promote patient safety, advance regulatory science, and support a least burdensome regulatory framework

Determine and employ audience-appropriate communication strategies.

Explain relevant regulatory issues clearly and concisely.