This in-depth, interactive two-day course was a refresher on current FDA medical device regulatory developments for new professionals in the medical device industry and seasoned regulatory affairs or legal professionals. Attendees heard from experts that reviewed the essential elements of medical device regulation.
Course Session Topics:
- Legal framework of device regulation, FDA's organizational structure and pre-market requirements
- Postmarket requirements, Quality System (QS) regulation, adverse event reporting, and advertising and promotion
- Key regulations and policies and how those regulations and policies are applied
- FDA's regulatory structure
- Preparing a successful 510(k) submission
- New and developing FDA policies and procedures affecting all phases of medical device regulation
- FDA's statutory authority, and emerging issues in the ever-changing regulatory landscape
The meeting helped you and your organization understand FDA regulations, support your efforts to get products approved, and know when FDA is likely to allege violations of the law.
- Regulatory and clinical affairs, legal, compliance, research and development, quality control, marketing, and management professionals in the medical device industry
- Reviewers of device applications and other regulators
- Law firm associates, and other lawyers and consultants who have an interest in medical device regulation
- Individuals seeking an overview of medical device law and regulation