Webinar on US FDA 510(k) – Latest Guidance, Due Diligence, Preparation, Submission and Clearance

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Category FDA Compliance, Food, Drugs & Biologics, Medical Devices

Deadline: December 14, 2016 | Date: December 14, 2016

Venue/Country: Online, Canada

Updated: 2016-12-02 21:15:49 (GMT+9)

Call For Papers - CFP

The United States Food and Drug Administration (FDA) recently issued final 510(k) guidance, providing FDA’s policy on the 510(k) program.

This seminar will provide a great opportunity to get familiar with how to best prepare for a 510(k) for submission to the FDA and clearance: in particular, recent trends including best practices (Dos and Don’ts).

Based on speaker’s recent experience, he will discuss best practices for adequately putting your 510(k) together compliant with the FDA’s policy and requirements.

This presentation will greatly help you streamline your 510(k) preparation and submission process at your firm for maximum benefits in a least burdensome, effective manner, in accordance with lastest guidance.

In this presentation, the speaker will share his PASS-IT solutions based on what he has learned from his own experience including his recent analysis of various different types of 510(k)s that have been recently cleared.

This presentation is a must for regulatory professionals working in medical device industry including those who are interested in the topic.

Areas Covered in the Session :

Laws And Regulations

Definitions

Device Classification

Predicates

Recent FDA Final 510(k) Guidance

When a 510(k) Is Required

510(k) Requirements

Substantial Equivalence: Factors to Consider and Special Considerations

Addressing e-Copy And RTA Policy Requirements

Common Mistakes for eCopy and RTA Policy Requirements

Common 510(k) Pitfalls to Avoid: Dos and Don’ts

What to Ensure While Preparing for a 510(k) Application

Responding to FDA’s Request of Additional Information.

Resolving Different Opinions and Interpretations

Best Practices for 510(k) Contents and Format

PASS-IT Recommendations: Dos and Don’ts

Who Will Benefit:

Medical Device Quality and Compliance Departments

Pharmaceutical Compliance Departments

Quality Departments

Regulatory Affairs Departments

CEOs

VPs

Attorneys

Clinical Affairs Professionals

R&D Departments

Consultants

Contractors/Subcontractors

Anyone Interested in the 510(k) Matters