By : Compliance Online
Date : 2012
Location : California / Palo Alto
This 510(k) training will discuss the submission process and the contents required by the FDA for a successful 510(k) submission. It will also provide an understanding of the common pitfalls, delays, and possible preventive measures.
510(k) submission process, 510(k) compliance training, 510(k) regulatory requirements, FDA regulatory requirements, FDA compliance training
This Medical device training will provide an understanding of how to get a device requiring a 510(k) submission to market quickly. Knowing when and how to properly submit a 510(k) for a device or change to a device is critical to a company’s regulatory and financial health. Your goal is to get the 510(k) through the review process as quickly as possible. This presentation will also distinguish between the standard, special and abbreviated 510(k)s, and explain when each is appropriate. This course will describe the submission process and the contents required by the FDA for a successful submission. It will also provide an understanding of the common pitfalls, delays, and possible preventive measures. Also described will be the type of activities a company can pursue while waiting for submission clearance.
Areas Covered in the Seminar:
- When to submit a 510(k) for a new or modified product.
- Types of 510(k) submissions and when to use each.
- What is the submission process.
- What is contained in a 510(k) submission package.
- How to know whether clinical data is required.
- How is the submission package assembled.
- User fees and 510(k) submissions.
- How to interact with the FDA and the reviewer.
- What to do if you make a change to your device.
Who will Benefit:
This webinar will provide valuable assistance to all medical device companies that prepare 510(k) submissions. The employees who will benefit include:
- Executive management
- Regulatory management
- Professionals involved with premarket notification to the FDA
- R&D personnel involved in approving the design of medical devices
- Sales personnel involved in approving the marketing of medical devices
Jeff Kasoff, RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for oversight of corporate compliance with domestic and international regulations, preparation of submissions, and is primary liaison with regulatory agencies and notified bodies.
Organizer : Compliance OnlineComplianceOnline is a Regulatory Affairs Professionals Society(RAPS) RA Professional Development Portal provider. ComplianceOnline is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs ComplianceOnline has agreed to follow RAPS-established operational and educational criteria