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Event :Preparing and Submit a Compliant 510(k) Submission

Date :Tuesday April 17th, 2018

Location :Training Doyens
26468 E Walker Dr
80016-6104 Aurora, United States

Type :Conference & Seminar - International audience

Accreditation :--


 

Further information

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) .

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

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/2pd1pH2

Email: support@trainingdoyens.com

Toll Free: +1-888-300-8494

Tel: +1-720-996-1616

Fax: +1-888-909-1882


Location

Map and directions
Conference address :
Training Doyens
26468 E Walker Dr
80016-6104 Aurora
United States
tel : +1-720-996-1616
Map and directions

Further information

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Details

Preparing and Submit a Compliant 510(k) Submission Pharmacy
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Everyone
50 1 --
English

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