Essential Regulatory Strategies for Medical Devices on the Class II / III Cusp

Over the course of a medical device Regulatory Professional’s career, it is inevitable that you will face with dillemas regarding how to guide the development of a novel medical device for which no clear predicate device exists. By statute and regulation, unless one can demonstrate “substantial equivalence” with a marketed device, then, by default, the proposed device will be relegated to a significant risk, Class III category. With this designation come higher development costs, a longer development cycle, and enhanced risks that the proposed device will not meet regulatory prerequisites for market authorization.

In this webinar, essential tactical tools will be discussed in detail with examples of when to apply one and not another. The tactical tools will be presented in the framework of an overall regulatory strategy so you can see the “forest for the trees” and effectively communicate your plan to senior management, the development team, and most importantly, to government regulators. As important as what you propose are your rebuttals to Regulator arguments for mandating compliance with higher classification requirements, including Investigational Device Exemption sanctioned clinical studies, statistically significant clinical data, and full GCP compliance.

Ample examples and sources for outside reading will be provided so that you can continue to learn more about these strategic steps long after the webinar has ended. Regulated products are becoming more complex – are your regulatory strategies evolving as well? Participate, learn more and be prepared for the future.

From a regulatory perspective, these types of medical devices reside on the cusp of Class II and Class III status. What you, as the Development Project’s Regulatory Leader, do to craft a strategy will have profound ramifications for the company in terms of profitability, not to mention the product’s likelihood of clearing regulatory hurdles. Do you have the skills and experience to navigate the rocky shoals of regulatory compliance and lead your team to marketing clearance or approval? Do your current strategies address national (U.S. FDA) and international regulatory requirements (EU, Canada, etc)?

An array of proven techniques and strategies exist to help guide you and the team to success.These strategies will be more valuable than ever as the lines blur between medical devices and drugs and other combinations of regulated products

• The essential tactical tools useful in thwarting higher classification designations
• Summary of the statutory basis for medical device classification, including Food, Drug & Cosmetic Act sections 513, and particularly the use of “de novo” classification petitions for “significant risk” devices
• Early phase product development strategies needed to capture the data necessary to defend against a higher risk classification (Class III)
• The most common flaws and pitfall in product development programs that increase the regulatory burden on a manufacturer
• Practical and immediate steps to take to dramatically reduce the cost of regulatory compliance for Class II/III devices
• Long-term strategies to ensure an efficient product development program

• Regulatory Affairs professionals
• Quality Assurance professionals
• Middle-to-senior management of Engineering / Product Development
• Consultants

Instructor Profile
Robert J Michalik , Esq., RAC, is a licensed attorney in Massachusetts and founder of RegulatoryPro.com, a consulting firm providing general and specialized services to the biopharmaceutical and medical device industries. Mr. Michalik has over 20 years experience working in the biopharmaceutical and medical device industries. Starting with a bachelor’s degree in science (biochemistry), Bob has held a wide variety of technical, quality and regulatory positions that literally span the scope of new product development and commercialization activities. In addition to his legal and regulatory practice, Mr. Michalik is also a faculty member at Northeastern University in Boston, MA where he teaches graduate-level coursework in the areas of FDA law and regulation within the Masters Degree in Regulatory Affairs program.

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