MMD-103 Understanding the US FDA Medical Device
The United States Food and Drug Administration (US FDA) is the regulatory authority overseeing the medical device industry to ensure safety, effectiveness, and quality. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), medical devices are classified into Class I, II, or III based on their risk level. Each class has different regulatory requirements, with higher-risk devices undergoing stricter approval processes.
Medical devices must comply with premarket requirements, including 510(k) Premarket Notification, Premarket Approval (PMA), or the De Novo classification process for novel devices. Additionally, manufacturers conducting clinical trials must adhere to Investigational Device Exemption (IDE) regulations before marketing their products. Compliance with Quality System Regulation (QSR) (21 CFR Part 820) is also crucial for ensuring consistent device manufacturing and performance.
Post-market regulations require manufacturers to conduct surveillance, reporting, and recalls if necessary. The Medical Device Reporting (MDR) system mandates reporting of adverse events, while FDA inspections assess compliance with regulatory standards. Failure to meet FDA requirements can result in warning letters, recalls, or market withdrawal, making compliance a critical aspect of medical device manufacturing and distribution in the US.
Medical devices must comply with premarket requirements, including 510(k) Premarket Notification, Premarket Approval (PMA), or the De Novo classification process for novel devices. Additionally, manufacturers conducting clinical trials must adhere to Investigational Device Exemption (IDE) regulations before marketing their products. Compliance with Quality System Regulation (QSR) (21 CFR Part 820) is also crucial for ensuring consistent device manufacturing and performance.
Post-market regulations require manufacturers to conduct surveillance, reporting, and recalls if necessary. The Medical Device Reporting (MDR) system mandates reporting of adverse events, while FDA inspections assess compliance with regulatory standards. Failure to meet FDA requirements can result in warning letters, recalls, or market withdrawal, making compliance a critical aspect of medical device manufacturing and distribution in the US.
- Understand the US FDA regulatory framework for medical devices.
- Identify device classifications and their corresponding approval pathways.
- Learn about 510(k), PMA, and De Novo pathways for device approval.
- Comprehend Quality System Regulation (QSR) (21 CFR Part 820) and compliance requirements.
- Gain insights into post-market obligations, recalls, and reporting requirements.
- Session 1: Introduction to US FDA Medical Device Regulations
- Session 2: Medical Device Classification & Regulatory Pathways
- Session 3: Establishment Registration & Device Listing
- Session 4: Introduction to 510(k) Submission Process
- Session 5: Preparing a Successful 510(k) Submission
- Session 6: Quality System & Post-Market Compliance
- Session 7: Case Studies & Q&A Session
- Regulatory Affairs professionals in the medical device industry
- Quality Assurance & Compliance teams
- R&D and Product Development teams
- Medical Device Manufacturers and Distributors
- Individuals handling FDA submissions and audits
This is a 2-days programme.
This course runs from 9:00am – 5:00pm with an hour for lunch and periodic short breaks.
This is an intensive session designed to include as much discussion as possible. Lunch and breaks provide an opportunity for further questioning and discussion with the instructors.
This course runs from 9:00am – 5:00pm with an hour for lunch and periodic short breaks.
This is an intensive session designed to include as much discussion as possible. Lunch and breaks provide an opportunity for further questioning and discussion with the instructors.
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