This course is intended to provide an overview of 2 new FDA draft guidance documents that clarify when medical device and software manufacturers must file a 510(k) (premarket notification) for changes to an existing device and/or software integrated with a device.

The FDA notes that while neither of these drafts specifically includes combination products, the general concepts may be helpful in determining whether changes to device constituent parts of combination products need a 510(k).

The guidance documents also do not address 510(k) submission requirements for remanufacturers of existing devices, such as re-processors of single-use devices.

Topic Background:

The first guidance document clarifies key terms and provides insight as to how a risk assessment can help medical device manufacturers to evaluate whether a new 510(k) is required.  Examples of device changes and recommendations for documenting a company’s decisions are provided.

The critical decision is whether a proposed change to a legally marketed medical device subject to premarket notification requirements is significant enough to require FDA review.  This includes any major change or modification to the intended use of the device that could have an impact on patient safety and effectiveness.

FDA provides a series of flowcharts and questions that can serve to guide medical device manufacturers to come to a conclusion as to whether a new 501(k) is necessary.  The flowcharts address changes to:

• Labeling
• Technology, engineering and performance
• Materials
• Technology, engineering, performance and materials for in vitro diagnostic devices

The second FDA guidance addresses proposed changes to software used in conjunction with a medical device.  The draft includes modifications made to correct software defects, provide patches or updates to code, and provide enhancements or modifications to functionality.  Software manufacturers must determine whether any change or modification could potentially and significantly affect the safety or effectiveness of a device.

The first step recommended by FDA is to conduct a risk assessment of the change, including all potential new risks along with known risks for the device.  Again, the FDA provides a flowchart to guide software manufacturers through the process of determining whether a 510(k) must be prepared.  FDA also provides examples of changes to software, along with an analysis as to why a new 510(k) would or would not be needed.

Course Objective:

This webinar includes the following key objectives:

• To learn how to interpret and apply the two draft guidance set forth by FDA on submission of a 510(k) for changes to medical devices and/or software used in conjunction with medical devices
• The understand the impact this guidance will have on the development, management and use of medical devices and software used in conjunction with medical devices that have been modified
• The course will provide useful information to medical device and software developers who manage changes to these devices and/or software
• The audience will learn what device changes and/or software changes will likely require the submission of a 510(k) and what ones will not
• We will discuss when and how the draft guidance documents should be applied in industry

Why Should You Attend:

This webinar is intended for those who are involved in manufacturing changes to medical devices and related software, and those conducting supporting clinical trials and other types of testing to demonstrate substantial equivalence in terms of a device’s safety and effectiveness.

Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.

You should attend this webinar if you are responsible for planning, executing or managing the modification of any medical device governed by FDA regulations, or if you are providing testing support.  

Course Outline:

• Medical Device changes
• Software Application changes for software used in conjunction with medical devices
• FDA Guidance Documents
• FDA Enforcement
• New 510(k) submission
• Flowcharts for decision-making related to specific changes:

o Labeling
o Technology, Engineering and Performance
o Materials

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Information Technology (IT) Analysts
• IT Developers
• IT Support Staff
• QC/QA Managers and Analysts
• Clinical Data Managers and Scientists
• Analytical Chemists
• Quality Managers, Chemists and Microbiologists
• Compliance Managers and Auditors
• Lab Managers and Analysts
• Automation Analysts
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders using Computer Systems regulated by FDA
• Regulatory Affairs Personnel
• Consultants in the Life Sciences and Tobacco Industries
• Interns working at the companies listed above
• College students attending schools and studying computer system validation, regulatory affairs/matters (related to FDA) or any other discipline that involves adherence to FDA regulatory requirements