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
Course Provider
Cheryl Wagoner,
