FDA's Guidance on Software and Device Changes and the 510(k)

    /Carolyn  /Troianospeaker of Training Doyensinvite
    Speaker: Carolyn Troiano

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    Duration: 90 Minutes
    Product Code: 51183
    Level: Intermediate

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The FDA has provided two guidance documents on software and device changes, which provide information as to whether a new 510(k) is needed.

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

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, 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 guidance 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.


Anyone who is involved in software and device design, modification, manufacturing, quality testing and distribution in the FDA regulated industries should be aware of these changes and the impact on decision-making as to whether or not to prepare a new 510(k). The FDA provides flowcharts that guide the reader to the best decision, but some judgment is also required.

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.

After attending this seminar, you will be able to better navigate the processes required to determine how to manage software and device changes in an FDA-compliant manner.


• Medical devices 510k changes
• How to manage software and device changes in an FDA compliant manner
• FDA guidance documents
• FDA enforcement actions
• New FDA 510(k) submission
• When to submit a 510(k)
• Flowcharts for decision-making related to specific changes:

    o Labeling
    o Technology, Engineering and Performance
    o Materials

• Q&A


• Learn about the FDA’s latest guidance on medical devices 510k changes
• Understand the three key areas of change that are discussed in the FDA guidelines for medical devices
• Learn about the questions to ask and decisions to make, based on flowcharts provided by FDA
• Gain confidence that changes will more likely be approved, given a thorough examination and explanation of impact of the change and potential risk


Manufacturing, Testing, Packaging and Distribution companies in the following industries that are regulated by FDA are required to follow GDPs:

• Pharmaceutical
• Medical Device
• Biotechnology
• Tobacco
• E-Liquid/Vapor
• E-Cigarette
• Cigar
• Third-Party companies that support those in the above industries, or manufacture, package or distribute on their behalf
• Colleges and Universities offering programs of study in Computer System Validation and Regulatory Affairs/Matters related to FDA

Personnel in the following roles 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 for labeling of devices


Years of Experience: 35+ years

Areas of Expertise: Strategic Planning, Project Management, FDA Regulatory Compliance, Organizational Development & Effectiveness, and Change Leadership & Management

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently managing a large, complex data migration, analytics and reporting program at a major financial institution.

During her career, Carolyn worked directly, or as a consultant, for many top-tier pharmaceutical companies in the US and Europe. She was responsible for computer system validation across all GxP functions at a major pharmaceutical company. Carolyn developed validation programs and strategies back in the mid-1980s, when FDA guidelines were first issued. She was an industry reviewer for 21 CFR Part 11, the FDA’s electronic record/electronic signature (ER/ES) regulation. She has taught ER/ES compliance, along with computer system validation and risk management/compliance at a number of Fortune 100 firms. Her experience includes work with FDA-regulated systems used in all areas of research, development, manufacturing, quality testing and distribution.

Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.

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