Medical Device 2013 - US laws and regulations governing medical devices and IVDs

Name of Topic:
US laws and regulations governing medical devices and IVDs
Why Should You Attend:
This webinar will greatly help you understand US regulatory requirements for medical devices including IVDs
Description of the Topic:
This webinar will walk you through the US laws and regulations governing medical devices including in vitro diagnostic medical devices (IVDs).
To bring medical products to the US markets, it is imperative that the device firms fully understand the regulatory requirements to obtain United States (US) Food and Drug Administration (FDA)’s clearance or approval. The Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) provides statutory requirements for marketing clearance or approval for medical devices including IVDs from US FDA. In this webinar, applicable statutory sections and corresponding FDA regulations applicable for medical devices including IVDs will be discussed.
This webinar is a must for device manufacturers (domestic and foreign) including component manufacturers, contract manufacturers, sterilization service providers, relabelers and repackers.
Areas Covered in the Session:
- Laws and regulations applicable
- Definitions
- Device labeling
- Information dissemination
- Performance standards
- Valid scientific evidence
- Pre-IDE
- IDE
- 510(k)
- De Novo
- 513(g)
- PMA
- HDE
- What regulators are looking for and their expectations
Who Will Benefit:
R&D
- RA/QA/QC
- CROs
- Consultants
- Contractors/subcontractors
- Senior management
Instructor Profile:
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.com). Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009. Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.
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