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Home » Store » Medical Devices » The New 510(k) Pathway: A Guide to Updated Requirements

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The New 510(k) Pathway

The New 510(k) Pathway: A Guide to Updated Requirements

$397.00
Medical Devices

Product Details

The FDA is modernizing the 501(k) framework to reflect advances in technology, safety and the capabilities of a new generation of medical devices.

What does this mean for your 510(k) submissions? You will need to know:

  • How to identify strong predicate devices
  • Common adverse events encountered in different device classes
  • Biocompatibility requirements
  • The best questions to ask to get the most out of a pre-submission meeting
  • Additional testing you may need to conduct
  • Strategic considerations when working with the FDA

The New 510(k) Pathway: A Guide to Updated Requirements management report explains the new rules for selecting predicate devices, changes in device classification, opportunities for pre-submission meetings with the agency, additional postmarket testing requirements and expansion of the third-party review program. This report covers two FDA pilot programs — the Software Precertification Program and Quality in 501(k) Review — along with a special safety and performance pathway for well-understood devices, changes to the de novo clearance pathway and the agency’s electronic submission requirements.

Management report takeaways: 

  • How to search for similar devices to use as predicates
  • What devices are exempt from the 510(k) process and which ones should use the de novo pathway
  • Criteria for suitable predicates
  • How to determine what testing is necessary and what kinds of tests to use
  • How to use the FDA databases to find product codes and consensus standards
  • Software validation requirements
  • How processes differ for reprocessed single-use devices

Streamline your 510(k) submissions and shorten your time to clearance with The New 510(k) Pathway: A Guide to Updated Requirements management report. Order your copy today.

Who Will Benefit

  • Regulatory affairs specialists
  • Medical device consultants
  • Biomedical engineers or R&D engineers working in product development

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ISBN-13:
978-1-60430-157-1

Publication date:
Dec. 2020

Page count:
445


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