Online Safety Community

Preparing and Submit a Compliant 510(k) Submission

Event Details

Preparing and Submit a Compliant 510(k) Submission

Time: April 17, 2018 from 1pm to 2pm
Location: 26468 E Walker Dr, Aurora, Colorado 80016
Street: 26468 E Walker Dr, Aurora, Colorado 80016
City/Town: Aurora
Website or Map: https://goo.gl/Vt7P6p
Phone: 18883008494
Event Type: online
Organized By: Training Doyens
Latest Activity: Mar 26

Export to Outlook or iCal (.ics)

Event Description

OVERVIEW

Since September 2009, the Centre for Devices and Radiological Health has been reviewing the operation of the 510(k) program and the way CDRH uses science in the decision making process. In August 2010, the 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making each released a preliminary report with a series of recommendations. Overall, industry has provided mostly a positive response but with exceptions. The proposals are more benign than many had feared. No radical change to the current process appears likely. Bottom line, FDA issued two comprehensive evaluations containing recommendations that address three key objectives of the agency’s public health mission as it relates to medical devices – foster device innovation, create a more predictable regulatory environment, and enhance device safety.

WHY SHOULD YOU ATTEND

This webinar provides an overview of the premarket notification process and all of the critical and key steps required to ensure you prepare and submit a well-constructed 510(k). Provides an overview of the 510(k) Program including the basics of how to prepare and submit a 510(k) to the FDA and recent changes and trends. There is no 510(k) form; however, 21 CFR 807 Subpart E describes requirements for a 510(k) submission. Before marketing a device, each submitter (the applicant) must receive an order, in the form of a letter, from FDA which finds the device to be substantially equivalent (SE) and states that the device can be marketed in the U.S.

AREAS COVERED

  • Statutory Requirements and Expectations
  • When a 510(k) Is Required and Not Required
  • Who is Required to Submit and Who is Exempt
  • Device Classification
  • Forms Required and to be Used 
  • Submission Methods: Log-In, Review Process and the Decision Letter 
  • Traditional/Special/Abbreviated 510(k) Submissions
  • Find and Use the Right Predicates
  • Pre-Sub (Q-sub) Approach and FDA Meetings
  • Substantial Equivalence: Factors to Consider and Special Considerations
  • Requests for Additional Information and How to Respond Effectively to the Reviewer
  • Is a New 510(k) Required for a Change or Modification to My Device 
  • Recent FDA Deficiency Categories for 510(k) Submissions and Pitfalls to Avoid
  • Recent FDA Final 510(k) Guidance

LEARNING OBJECTIVES

This webinar will provide valuable assistance and guidance to medical device and IVD companies involved in any aspect of the 510(k) process.

WHO WILL BENEFIT

  • All levels of management and departmental representatives any anyone who desire a better understanding or a "refresh" overview of the 510(k) process 
  • CRO’s 
  • Regulatory Affairs/RA Specialists
  • Clinical Affairs
  • Project Leaders
  • Quality and Compliance
  • Marketing & Sales 
  • Distributors/Authorized Representatives
  • Engineering/Technical Services/Operations
  • Consultants

 

For more detail please click on this below link:

http://bit.ly/2FULR13

 

Email: support@trainingdoyens.com

Toll Free: +1-888-300-8494

Tel: +1-720-996-1616

Fax: +1-888-909-1882

Comment Wall

Comment

RSVP for Preparing and Submit a Compliant 510(k) Submission to add comments!

Join Online Safety Community

Attending (1)

Take our poll!

Take our poll!

Latest Activity

Simon Hopes posted a blog post

Speed governor is a technical invention

The popularity of Watt's improved steam engine was rapid, and by 1790 the old Newcomen steam engine was out of sight, and by 1790 there were about 500 steam engines operating in Britain. After less than 100 years or so, by 1868, there were as many as 75,000 steam engines in Britain alone. In 1805, the steam engine in the United States was equipped with cars as a driving force. In 1807, Robert Fulton (1765-1815) of the United States invented a steamship powered by a steam engine. In 1825 George…See More
yesterday
HrishikeshRam posted blog posts
yesterday
Russel Stuart posted a blog post

HR Documentation is a Vital Aspect of Organizations

HR documentation is of vital importance to organizations. Unless its nuances are mastered organizations can fall into embarrassing and damaging pitfalls.HR documentation is one of the most important aspects at the workplace. The habit of HR documentation is usually imbibed into HR professionals from early on in their careers. But what does HR document?HR documentation resonates with the spirit of the dictum, Verba volant, Scripta manent, meaning "what is written stands; what is uttered flies".…See More
Friday
Laticia Gibson posted a blog post

Searching A Best Dental Clinic Is Important

Keeping a perfect oral health is crucial. Though, in keeping good teeth set, always it has been a must to research for the good General Dental office you can find in your nearby area. It has to be noted that searching the most suitable clinic can confirm you of good quality and pleasing services. Earlier than you make a selection, there are some important things you have to know.The Crucial Things to…See More
Friday

Forum

Road Safety

What can be the best measures for Road Safety?Continue

Started by Jen McDade Sep 27.

safety equipments in breweries 4 Replies

safety equipments in breweries -- kindly provide detailsContinue

Started by ajit. Last reply by Jen McDade Sep 24.

Unusual Safety Tips 10 Replies

Please share some unusual but genuine safety precautions.My unusual safety tips - Don't drink sweet fruity juice while driving in the night as it contains sugar and sugar slows down your blood…Continue

Started by Arnold Brame. Last reply by Jen McDade Sep 24.

Safety products 9 Replies

While working or at some work stations, employees are exposed to threats or at times suffer severe injuries. The safety of the employee should be the foremost priority. Safety equipment aids help in…Continue

Tags: equipments, and, products

Started by Enna Henry. Last reply by Jen McDade Sep 24.

Talend Application Integration

APPLICATION INTEGRATION:Talend ESB and Application Integration delivers agile real-time integration of applications and data.Heterogeneous Application and Data IntegrationTalend’s open source ESB…Continue

Tags: york, new, certification, training, talend

Started by nicolewells Sep 21.

Badge

Loading…

© 2018   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service