Bullet Proof 510(k) - Latest FDA Changes to the Process

Overview:

There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated. The Special and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm" to help streamline the 510(k) review process.

Product modifications that could significantly affect safety and effectiveness are subject to 510(k) submission requirements under 21 CFR 807 as well as design control requirements under the Quality System (QS) regulation. Under the QS regulation, all Class II and III devices and certain Class I devices are required to be designed in conformance to 21 CFR 820.30 Design Controls. FDA provides guidance and this course will address key resources when making critical decisions.

Objectives:

• Know the differences between the Traditional, Special and Abbreviated submissions
• Understand Substantial Equivalence and how it is applied
• Who is required to submit the application to FDA
• Where to submit the 510(k) and what to expect with the review and approval process
• When it is and is not required if you are a device company
• Exemptions to the submission process and special considerations
• How to locate a "predicate" device and go through the content and format of the 510(k)
• Understand the De Novo process and the expectations for possibly marketing a low risk device
• Understand the potential impact of FDA's proposed changes to the 510(k) process and why manufacturers need to pay attention

Detailed Agenda:

Introduction and Regulatory Background

• There is no 510(k) form; however, 21 CFR 807 Subpart E describes requirements for a 510(k) submission
• Current trends with the 510(k) process

The Process

• Who is Required to Submit a 510(k)
• When a 510(k) is Not Required
• When a 510(k) is Required
• Locating and justifying the Predicate
• Substantial Equivalence and demonstration of SE to another legally U.S. marketed device
• How to Prepare Submissions
• 510(k) Submission Methods
• List of forms associated with Premarket Notification 510(k) submissions
• Deciding When to Submit a 510(k) for a Change to an Existing Device
• What happens if FDA requires additional information and data and your responsibilities

Interactive Q&A, Wrap-Up and Adjourn

• Q&A with all attendees
• Group discussion and review of recent 510(k) clearances and proposals and recommendations between FDA and industry
• Discussion Points: some of the recommendations have included, but not limited to, redefining fundamental terms, limiting use of predicates, greater authority to rescind 510(k)s, etc.
• 510(k) Frequently Asked Questions
• Attendees should be prepared to address any issues and challenges as experienced on behalf of their company in this open-forum and interactive session

Who Will Benefit:

• This course is appropriate to those involved in all aspects of the premarket notification, i.e., 510(k) process on behalf of medical device and In Vitro Diagnostic manufacturers. It is both a primer for personnel new to the FDA 510(k) process, or an excellent refresher course for those who need to revisit the basics and fundamentals for a better understanding on how to prepare and submit your application to ensure regulatory and compliance success. Those who will benefit include professionals in R&D, development, quality assurance and quality control, production,operations, engineering, compliance, and regulatory affairs and all levels of management, including technical and laboratory personnel who desire to understand what it takes to prepare and submit a bulletproof 510(k) to FDA while at the same time are aware of the changing regulatory landscape regarding FDA's proposed changes to the 510(k) process