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Assessing FDA’s Proposed Changes to the 510(k) Process in 2011

 
  December 30, 2010  
     
 


ComplianceOnline, Online Event
2011-01-26


NOTE: Use This Promocode ( 117660 ) To Get 10% Discount. 

Why Should You Attend:

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 recommendations are not official guidance yet as they will be open to public comment, and there are in excess of 70 proposed changes that, taken together, could result in a significant disruption to a program that has served patients well for more than 30 years. Following the public comment period CDRH said it will announce which recommendations it will implement as well as the projected timelines for implementation.

This 520(k) webinar will address both sides of the proposed changes. We will discuss how the expected change will affect device makers in terms of additional cost, affect on number of devices cleared, what is the regulatory process for implementing the changes. We will also discuss what industry has to prepare for the statutory changes coming in 2011.

Areas Covered in the Seminar:

  • Redefinition of terms such as Intended Use/Indications for Use, limiting use of predicates, consideration of off-label uses, greater authority to rescind 510(k)s and other changes.
  • Understand recommendation for a new subclass of Class 2 products for which clinical studies will be required.
  • Learn of possible changes in the de novo process that could streamline the clearance process.
  • Obtain latest recommendations and comments from various device trade groups.
  • How will the expected changes affect device makers?
  • What additional costs might device makers face in light of new regulatory requirements?
  • What will the proposed changes mean for the number of devices cleared?
  • How will the proposed changes affect so-called "split-predicates"?
  • What is the regulatory process for implementing the recommendations?
  • What can device companies do to prepare for upcoming changes?
  • Industry needs to prepare for these “likely” statutory changes in 2011

Who Will Benefit:

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

  • All levels of management and departmental representatives any anyone who desire a better understanding or a "refresh" overview of the proposed changes
  • Regulatory Affairs/RA Specialists
  • Clinical Affairs
  • Quality and Compliance
  • Marketing & Sales
  • Distributors/Authorized Representatives
  • Engineering/Technical Services/Operations
  • Consultants
 
 
Organized by: ComplianceOnline
Invited Speakers:

David R. Dills, an independent Regulatory & Compliance Consultant with more than 22 years of hands-on experience and a proven track record within the life sciences and FDA regulated industry, has an extensive regulatory background with Class I/II/III and IVD devices and managing and handling activities within the global regulatory landscape. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses EU regulatory requirements regarding MDD and CE Mark. Background encompasses broad capabilities in quality systems, validation, regulatory affairs, compliance, auditing, interfacing with the regulatory agencies, Notified Bodies, AR’s and demonstrates credible experience to maximize business performance in the devices arena. He strives to optimize business performance through proactive strategies to mitigate compliance exposure by providing strategic and tactical solutions that facilitate the achievement of regulatory milestones.

David has been previously affiliated with well-known device manufacturers and service providers and has served in various quality, regulatory and compliance management and advisory capacities with increasing responsibilities. David is an industry speaker and author of technical and compliance related topics published in industry journals. Please refer to his profile provided herein for additional information about his background and areas of interest and expertise.

 
Deadline for Abstracts: 2011-01-26
 
Registration:

Attend Live Online Training 

$449.00 One Dial In - Unlimited Participation in a conference / Meeting Room 

E-mail: admin@complianceonline.com
 
   
 
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