Under FDA’s regulatory regime, most devices that the agency has classified into Class II -- those subject to Special Controls -- and some in Class I -- those subject to general controls - require that the person seeking to market the device first must secure FDA clearance of a Premarket Notification Submission, commonly known as a “510(k)” from the specific statutory provision requiring the filing. To secure 510(k) clearance, the submitting party must demonstrate that its device is “substantially equivalent” to an already marketed lawful device.
In this webinar, we will review several vital issues relating to the 510(k) process including:
- How FDA classifies devices.
- How to determine if a product is substantially equivalent to a previously marketed device (referred to as a “predicate device”).
- Challenges presented when a device differs from a predicate device – can you still use that predicate to support your 510(k)?
- When a change to a previously submitted cleared 510(k) will require that the company submit a new 510(k) to cover the change. Here, we also will review several programs -- known as Special or Abbreviated 510(k)’s -- FDA has implemented that allow companies to make changes to 510(k)’s and sidestep some of the more typical requirements in a “traditional” 510(k).
We also will explore some of the criticisms that have been levealed at the 510(k) process in recent years and discuss how those critiques have impacted the process both positively and negatively and what they may portend for the future of the 510(k) process.
Who Should Attend:
Executives and professionals from medical device companies, including those in the in vitro diagnostic industry, with responsibility in the following areas:
Research and Development
Operations and Manufacturing
Q/A Session with the Expert to ask your question
Handouts (PDF print only copy of PowerPoint slides)
60 Minutes Live Presentation
Certificate of Attendance
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