Putting together a Q-Submission and 510(k): Best Practices

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Deadline: April 29, 2014 | Date: April 29, 2014

Venue/Country: 38868 Salmon Ter, Fremont, U.S.A

Updated: 2014-04-17 17:09:27 (GMT+9)

Call For Papers - CFP

Description:

This webinar will provide an opportunity to get familiar with an FDA's process to communicate with the industry early in the process for sustainable 510(k) preparation and submission.

This webinar is intended to discuss how to put together a pre-submission (Q-submission) to obtain FDA feedback on your proposed questions, which will be helpful and useful for your device design, preclinical and clinical study plan and design, if applicable.

The speaker will discuss contents and format for a Q-submission and 510(k)compliant with the FDA's eCopy and RTA policy, helping you streamline your dialogue with the FDA for maximum benefits while preparing for a 510(k) submission in a least burdensome, effective manner.

In this webinar, 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 webinar is a must for regulatory professionals working in medical device industry including those who are interested in the topic.

Objectives of the Presentation:

Statute(s) And Regulations

Definitions

Device Classification And Predicates

510(k) Program

When 510(k)s Are Required

Applicable Regulatory Requirements: Biocompatibility, Software, Risk Management, etc.

Pre-Submission (Q-Submission) for a 510(k): Requirements, Contents and Format

Substantial Equivalence: Factors to Consider and Special Considerations

Addressing e-Copy And RTA Policy Requirements

Applicable Standards and Guidance

510(k) Contents And Format

Common Pitfalls and How to Prevent Them

What to Ensure While Preparing Your Q-Submission and a 510(k) Application

Responding to FDA's Request of Additional Information.

Resolving Different Opinions and Interpretations

Best Practices for a Q-submission

Best Practices for a 510(k) Preparation, Submission and Clearance

Speaker's Practical, Actionable and Sustainable Solutions

Conclusions

Who can Benefit:

RA

R&D

QA/QC/QS

CROs

Consultants

Contractors/Subcontractors

Senior Management

Anyone interested in 510(k) matters

http://www.onlinecompliancepanel.com/ecommerce/webinar/~product_id=500277?expDate=Ourglocal