How to file a 510(k) when your device is (or contains) software

Instructor: Cheryl Wagoner
Product ID: 703366
Training Level: Intermediate
  • Duration: 75 Min

recorded version

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Read Frequently Asked Questions

The Webinar will discuss the structure and level of detail required in filing a 510(k) when a medical device is software or contains software.

Why Should You Attend

In September 1999, FDA issued a guidance document entitled “Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices.” In May 2005, FDA issued another document entitled “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.”

Though these guidance documents are not new, there remains some confusion by industry regarding the use of software in medical devices. This webinar will attempt to provide some clarity. It will discuss the key elements required for a 510(k) application when the device contains software.

Areas covered in this webinar:

  • Define software use in medical devices. What makes your software a medical device?
  • Defining and supporting Level of Concern determination
  • What specific software –related documentation is required? How does the Level of Concern (LOC) determination impact this?
  • Risk Assessment/Mitigation and its relationship to the LOC
  • Software change management and its relationship to the LOC
  • V and V (Verification and Validation)
  • When is a 510(k) needed for Off the Shelf (OTS) software?
  • Could the Special 510(k) or Abbreviated 510(k) apply to your application?
  • Exemptions to the 510(k) requirements
  • Labeling of Software devices

Learning Objectives:

Upon completion of this session, attendees will understand the elements required for a 510(k) application when the device contains software.

Who Will Benefit:

  • Regulatory managers
  • Project managers
  • Regulatory specialists who compose 510(k) applications for software
  • Product Development managers
  • Documentation
  • Medical device IT/IS
  • CROs

Instructor Profile:

Cheryl Wagoner, has 20 years of experience in quality assurance, and regulatory affairs. She currently is the Principal Consultant/Owner of Wagoner Consulting LLC, where she provides consulting services to medical device and pharmaceutical companies. Previously, she has held various positions in Quality, Regulatory, Clinical and Compliance in the medical device and pharmaceutical industries.

Cheryl is a member of Regulatory Affairs Professionals (RAPS), Association for the Advancement of Medical Instrumentation (AAMI), Medical Device Manufacturers (MDMA) FDA Working Group, and the MDMA Compliance Working Group. She completed the RAPS Executive Development Program at the Kellogg School of Management.

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