US FDA Regulations for Medical Devices Training

Module 1

An Overview of US FDA Regulations for Medical Devices

• FDA’s role in regulating medical devices
• Definition and Classification of Medical Devices
• Steps to Market your device
• Premarket Submissions
• Q & A

Module 2

Steps to Market your Device

• Know Your Product
• Confirm the Product is a Medical Device
• Special Devices
• Determine Classification and Regulatory Pathway
• Premarket Submission
• Practical example
• Q & A

Module 3

Device Registration and Listing

• What is Registration and Listing?
• Am I Required to Register and List?
• Who is Exempted from Registration and Listing?
• Times for establishment registration and device listing.
• Registration and Listing Steps
• Establishment Registration User Fee : DFUF
• FDA Unified Registration and Listing System : FURLS
• Q & A

Module 4

Submission: 510(k)

• What is 510(k) submission
• Types of 510(k) Submission
• Documents required for 510(k) submission
• Review Timeline
• Q submission
• How to Do eSTAR submission : Practical approach
• Q & A

Module 5

Submission PMA & De Novo Classification

• Understand the regulatory pathways for PMA and De Novo Classification.
• Differentiate between PMA and De Novo submission requirements.
• Learn the steps involved in the PMA submission process, including clinical data and FDA review.
• Understand the criteria and process for De Novo Classification, focusing on risk-based evaluation.
• Identify best practices for preparing and submitting successful PMA and De Novo applications.
• MDUFA & SBD Program and how to apply for that.
• Q & A

Module 6

Explore USFDA website and Useful Data Base

• Explore and understand 21 CFR
• Different Data Base (510(k), TPLC, Classification, etc)
• Explore USFDA Website Important Links : Guidance, Forms
• Q & A