510(k) Submissions: Requirements, Challenges and Successful Clearance
Overview:
A premarket notification [510(k)] submission is the most common pathway to market for medical devices including in vitro diagnostic devices.
The 510(k) submission is made to the U.S. Food and Drug Administration (FDA) to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device (predicate device) as described in 21 CFR 807.92(a)(3). For the past few years, the 510(k) program has been evolving (e.g., 510(k) actions and improvements). In addition, the recent FDA draft guidance document suggests that more 510(k) submissions be required to meet the regulatory requirements. Thus, to bring medical device products to the US market fast, it is imperative that medical device industry quickly recognize the recent changes in the 510(k) process, and understand and adapt to the new requirements to greatly facilitate the review process in a proactive and streamlined manner. This webinar will help you to greatly improve your 510(k) strategy and submission quality by sharing practical and actionable information.
This webinar will discuss:
- 510(k) program and recent changes (e.g., 510(k) actions and improvements)
- How to identify and assess the regulatory requirements
- How to meet the regulatory requirements
- How to increase 510(k) submission quality
- How to format a 510(k) submission to proactively facilitate the review process
- Some template forms, which are applicable for both general medical devices and in vitro diagnostic devices, will be discussed
Why should you attend: If you don't know the answers to the following questions, you should attend this webinar:
- What is 510(k)?
- What is a 510(k) submission?
- What are the applicable federal statutes and implementing regulations for 510(k) submissions?
- How the medical devices are classified?
- What are the challenges and hurdles during the 510(k) preparation, submission, and review process?
- How to identify applicable regulatory requirements?
- How to demonstrate applicable regulatory requirements (e.g., performance requirements including clinical studies, if applicable)?
- What are the common deficiencies in 510(k) submissions?
- How to format a 510(k) submission using the CAC-SI method?
Areas Covered in the Session:
- FDA regulations applicable to a 510(k) submission
- 510(k) program and recent changes in the 510(k) program
- 510(k) regulatory requirements
- 510(k) submission requirements for medical devices and in vitro diagnostic devices
- List of applicable FDA guidance documents
- List of applicable reference standards
- Systematic methods to increase 510(k) submission quality.
- Formatting a 510(k) for submission
- 510(k) submission template for medical devices.
- 510(k) submission template for in vitro diagnostic devices.
- Instructor's unique practical and actionable strategy
- CAC-SI method
Who Will Benefit:
- Regulatory Affairs
- Quality Associates
- Compliance Specialists
- Research and Development (R&D) Managers
- Product and Development (P&D) Managers
- Risk Management
- Sales and Marketing Managers
- Clinical Affairs Managers
- Site Managers
- Senior and Executive Management
- Legal Counsel
- Anyone Interested in learning about 510(k) process and submission