The 510(k) Process: Evaluating Substantial Equivalence in Premarket Notifications

Why Should You Attend:

The process of compiling and submitting a 510(k) for medical device companies, especially small companies, can be ambiguous. It requires considerable investment of time and resources. Toiling through this process can be overwhelming and also a constant struggle with bureaucratic hurdles. Understanding how this process works and the reasoning behind the FDA’s decision making process can not only save time and money, but also position the company in market advantage.

This webinar will give you a better understanding of FDA’s current position regarding the 510(k) process and provide you with the resources necessary to develop a better regulatory strategy. It will detail the process of demonstration of substantial equivalence, the 510(k) process, and also highlight best practices for premarket notification 510(k) submissions.

Areas Covered in the Webinar:

• Device classification as it relates to 510(k)s
• Device classification
• Overview of 510(k) program
• Content of a 510(k)
• 510(k) submission process
• 510(k) decisions

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

• Regulatory Affairs
• Quality Assurance
• Compliance
• Research and Development
• Quality Engineering
• Risk Managers
• Executive Management
• Risk Management

Instructor Profile:

With a double major in mechanical engineering and mathematics and a master’s in biomedical engineering, Ana Maria Saaibi has more than 6 years of medical device experience in both product development and quality and regulatory affairs. She has lead device work for both the U.S. domestic market and international markets. She has experience in medical device regulatory submissions to the FDA (US), INVIMA (Colombia) and Notified Bodies for the CE Mark as well as the development of quality management systems compliant with ISO 13485:2003, FDA QSR and MDD. Ms. Saaibi is an ASQ (American Society of Quality) certified biomedical auditor since 2012 and a RABQSA auditor in training.

Topic Background:

To be cleared for market in the U.S., a new device must be found substantially equivalent (SE) to a predicate device according to the Federal Food, Drug, and Cosmetic Act (FDC Act). To be found SE, the new device must have the same intended use as the predicate and either the same technological characteristics as the predicate, or, if different technological characteristics exist, those differences cannot raise different questions of safety and effectiveness than those of the predicate device. The device must demonstrate that it is as safe and effective as the legally marketed device. This demonstration of substantial equivalence is commonly referred to as the 510(k) process.

The FDA released the new guidance for the 510(k) program and the substantial equivalence determination on July 28th of this year. FDA developed the document to provide guidance to the industry and FDA staff about current review practices for premarket notification 510(k) submissions. The intent of this guidance is to identify, explain, and clarify each of the critical decision points in the decision-making process FDA uses to determine substantial equivalence.

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