Medical Device Regulatory Affairs is a course that provides a comprehensive and easy to understand overview ofcurrent FDA regulatory compliance with respect to developing and marketing medical devices. The course presentsrelevant aspects of FDA regulations and the practical aspects of bringing a medical product to market, including the 510(k) process (pre-market submission made to the FDA to demonstrate that the device to be marketed is safe and effective) and pre-market approval (PMA) processes (scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices). The course also covers Good Manufacturing Practices (GMP) concepts, medical device registration, listing, reporting, and outlook for the future.
After completing Medical Device Regulatory Affairs, students will be equipped with a basic understanding of the following:
- Medical device classification
- 510(k) clearance to market
- Pre-market approval
- GMP concepts
- Outlook for the future
No prior experience or coursework required.
Students will be assigned 5 homework assignments, and 1 final exam.
- Medical device definition
- Medical device examples
Medical Device Classifications
- Class I General Controls (with and without exemptions)
- Class II General Controls and Special Controls (with and without exemptions)
- Class III General Controls and Premarket Approval
510(k) Clearance to Market
- What is 510(k)?
- 510(k) submission process
PMA (Pre-Market Approval)
- What is a PMA?
- Federal Food, Drug, and Cosmetic Act- Section 515(c)(1)
- Information reporting
- Statement of components and properties
- Description of materials and methods
Good Manufacturing Compliance (GMP) Compliance
- What is GMP?
- Compliance to 21 CFR 820
- Quality System Regulation- ISO 9001:1994
Medical Device Registration, Listing, & Reporting
- Establishment registration- compliance to 21 CFR 807
- Listing- compliance to 21 CFR Part 862 to 892
- Reporting- compliance to 21 CFR 803
Medical Device Outlook
This course is Instructor-led and delivered through our award-winning online Learning Management System.