The FDA regulates medical devices marketed and sold in the U.S. on the basis of potential risk and according to a three category classification system.
This course on the U.S. Food and Drug Administration’s 510(k) clearance and premarket approval process is intended to provide attendees with an introduction to the U.S. FDA regulation of medical devices. It will cover the FDA and its regulatory authority as it relates to medical devices. The presenter will discuss the FDA’s medical device classification system and offer suggestions for determining how a particular device will be classified and regulated. The process for going to market with a Class I, Class II and Class III device will be described with particular attention being paid to the preparation and submission of 510(k)s and PMAs.
This seminar will also provide an overview of a medical device manufacturer’s and/or distributor’s regulatory responsibilities as well as issues related to the FDA’s requirements governing medical device manufacturing, labeling and user fees. It will cover strategies for preparing and surviving the FDA on-site inspection. Finally, an overview of FDA’s medical device-focused enforcement activities and methods for mitigating enforcement risks will be discussed.
Upon completing this course on FDA regulation of medical devices, participants will:
- Gain a basic understanding of the FDA’s structure and its laws and regulations applicable to medical devices.
- Develop a familiarity with the FDA’s Medical Device Classification System and learn the difference between Class I, Class II and Class III medical devices.
- Understand the difference between a 510(k) and a PMA, and when each is required.
- Learn what is included in a 510(k), how to prepare a 510(k) and the process for selecting a predicate device.
- Develop a basic understanding of the FDA’s Quality System Regulation (21 CFR Part 820).
- Learn what is involved in an FDA inspection, how to prepare for an FDA inspection and strategies for undergoing a successful inspection.
- Become familiar with the FDA’s various enforcement options as they relate to medical device marketing and sales
Who will Benefit:
This course is designed for people tasked with developing a regulatory and business strategy for the marketing and sale of medical devices in the United States. This includes individuals who are responsible for ensuring medical device compliance with the FDA’s regulatory requirements and obtaining the relevant clearance or approval needed to market and sell such products, and those tasked with the shipping and export of medical devices to the U.S. The following personnel will benefit from the course:
- Medical Device Manufacturers
- Senior Regulatory Professionals
- Compliance Professionals
- Medical Device Designers / Design Engineers
- Corporate Legal Departments
- Medical Device Exporters and Importers
- Regulatory Consultants
- Research Analysts
- Production Supervisors
- Quality Control Personnel
- Medical Affairs
- Regulatory Auditors
- Customs Brokers
- Medical Device Labelers
- Convenience Kit Manufacturers
- State Policy Officials
- Investment Analysts
- Venture Capitalists
- M&A Professionals
The FDA regulates medical devices marketed and sold in the U.S. on the basis of potential risk and according to a 3 category classification system. Class I medical devices are deemed to be low risk and possess the lowest regulatory threshold for entry into the market. Class II medical devices are deemed to present an intermediate risk to the user and requires the submission of a 510(k) Premarket Notification establishing substantial equivalence to a selected predicate device. Finally, Class III devices are considered novel and unique, and are deemed to pose a higher level of risk than the other device categories. Class III devices require FDA Premarket Approval prior to marketing and sale.