2-day In-person Seminar on “How to Prepare and Submit a Bullet Proof 510(k) and Latest FDA Proposed Changes to the Process” at Philadelphia

Overview:

This one-day course is a primer and overview to the premarket notification process, i.e., a 510(k). A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA. There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated. 

Course Outline:

Day 1 – Agenda

Lecture 1: 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.

Lecture 2: 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

Day 2 – Agenda

Lecture 3: Interactive Q&A, Wrap-Up and Adjourn

• Q&A with all participants and 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 and participants should be prepared to address any issues and challenges as experienced on behalf of their company in this open-forum and interactive session

About Speaker: 

David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space. 

Date, Venue and Price:

Location: Philadelphia, PA

Date: November 7th & 8th, 2013 | 8:30 AM to 5 PM

Venue: DoubleTree by Hilton Hotel Philadelphia Center City 

Address: 237 South Broad Street, Philadelphia, Pennsylvania, 19107-5686, USA

Price: $1295.00

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