Deciding When to Submit a 510(k) for a Change to an Existing Device - FDA's Final Guidance

Why Should You Attend:

This presentation uses the latest FDA thinking and guidance documents to assist the manufacturers in enhancing the predictability, consistency, and transparency of the “when to submit” decision-making process by providing a least burdensome approach, and describing in greater detail the regulatory framework, policies, and practices underlying such a decision.

Case Study Examples will be provided for each session to further assist the attendees in understanding how to decide when to submit a 510(k) for a change to an existing device.

Learning Objectives:

• The main types of changes that might be made to a device
• Labeling changes
• Technology, engineering, and performance changes
• Materials changes
• Technology, engineering, performance, and materials changes for in vitro diagnostic devices (IVDs)
• Considerations for risk-based assessments of modified devices

Areas Covered in the Webinar:

Session #: 1

Duration: 30 minutes

Learning Objectives: The main types of changes that might be made to a device: When a manufacturer modifies their device with the intent to significantly affect the safety and effectiveness of a device (for example to significantly improve clinical outcome or to mitigate a known risk) submission of a new 510(k) is likely. Other changes, however, need to be evaluated for whether the change could significantly affect device safety and effectiveness plus for whether the change impacts the device substantial equivalence from the existing device.

1. Changes made with intent to affect device safety & effectiveness
2. Initial Risk Based Assessment
3. Use of Risk Management
4. The role of validation & verification to determine whether a change could significantly affect device safety and effectiveness
5. Evaluating simultaneous changes to determine whether submission of a new 510(k) is required
6. Appropriate comparative device and cumulative effect of changes
7. Substantial equivalence determination

BREAK –

Session #: 2

Duration: 30 minutes

Learning Objectives: Labeling changes: This session identifies several types of labeling changes or modifications to an existing device, including certain changes to the indications for use, that can have a major impact on intended use and thus require submission of a new 510(k). Focusing on indications for use and using a risk-based assessment for labeling changes to help identify those changes that are more frequently recommended for documentation only, are discussed.

1. Is it a change in the indications for use statement?
2. Does the change add or delete a contra-indication?
3. Is it a change in warnings or precautions?
4. Could the change affect the directions for use of the device?

BREAK –

Session #: 3

Duration: 30 minutes

Learning Objectives: Technology, engineering, and performance changes: These types of changes encompass a broad span of design activities, from minor engineering changes in a circuit board layout to a change from electromechanical to microprocessor control of device function. They need to be evaluated and verified and/or validated according to the QS requirements. If the results of the verification and/or validation raise any unexpected issues, how to determine whether submission of a new 510(k) is required.

1. Is the device an in vitro diagnostic device?
2. Is it a control mechanism, operating principle, or energy type change?
3. Is it a change in sterilization, cleaning, or disinfection?
4. Is it a change to an “established category B” or “novel” sterilization method, does the change lower the sterility assurance level, or is it a change to how the device is provided?
5. Could the change significantly affect the performance or biocompatibility of the device?
6. Is there a change in packaging or expiration dating?
7. Is the same method or protocol, as described in a previously cleared 510(k), used to support the change?
8. Is it any other change in design (e.g., dimensions, performance specifications, wireless communication, components or accessories, or the patient/user interface)?

BREAK –

Session #: 4

Duration: 30 minutes

Learning Objectives: Materials changes: Firms making changes to the materials from which their device is manufactured need to consider the changes discussed above and their impact on the decision regarding submission of a new 510(k). For example, a material change, might also lead to a change in the labeling of the device (e.g., the removal of a contraindication or the addition of a new warning), or a change in specifications (e.g., a reduction in the strength of the device).

1. Is the device an in vitro diagnostic device?
2. Is this a change in material type, material formulation, chemical composition, or the material’s processing?
3. Will the changed material directly or indirectly contact body tissues or fluids?
4. Does a risk assessment identify any new or increased biocompatibility concerns?
5. Has the manufacturer used the same material in a similar legally marketed device?
6. Could the change affect the device’s performance specifications?

BREAK –

Session #: 5

Duration: 30 minutes

Learning Objectives: Technology, engineering, performance, and materials changes for in vitro diagnostic devices (IVDs): Changes in technology, engineering, performance, or materials of an IVD can include changes made to reagents or changes to a test method or protocol, among other things. This session will examine whether these changes require a 510(k) to be submitted, as well as whether other changes, e.g. labeling changes need to be made.

1. Does the change alter the operating principle of the IVD?
2. Is the change identified in a device-specific final guidance or classification regulation?
3. Does a risk-based assessment of the changed device identify any new risks or significantly modified existing risks?
4. Do design verification and/or validation activities produce any unexpected issues of safety or effectiveness?

BREAK –

Session #: 6

Duration: 30 minutes

Learning Objectives: Considerations for risk-based assessments of modified devices: This session provides guidance on the principal factors to consider in conducting a risk-based assessment to determine whether a device change leads to a significant change in the device’s risk profile.

1. Likelihood or probability of occurrence of harm
2. Severity of harm
3. Device effectiveness

Q&A -

Who Will Benefit:

• Quality Managers
• Quality Engineers
• Regulatory Affairs
• Small business owners
• GxP
• Consultants
• Quality VPs
• IT VPs
• Lab Directors
• Scientists
• FDA investigators
• Other regulatory agency investigators

Angela Bazigos
CEO, Touchstone Technologies Inc

Angela Bazigos is the CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety and Turnarounds. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers, Public Health Service. Positions include Chief Compliance Officer, http://morflearning.com/angelabazigos/, QA Director, Director of MIS. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA http://www1.diahome.org/~/media/4FA562336EBD46C58CDC43A8B7773095.ashx. Patent on speeding up software compliance https://www.google.com/patents/US8266578 . Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom http://blogs.wsj.com/riskandcompliance/2015/07/24/using-training-to-bring-compliance-to-boardrooms/ . Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for LifeSciences: http://www.stanfordwhoswho.com/Angela.Bazigos.7144112.html#overview.

Topic Background:

A premarket notification (510(k)) is required when a legally marketed device subject to 510(k) requirements is about to be significantly changed or modified in design, components, method of manufacture, or intended use. Significant changes or modifications are those that could significantly affect the safety or effectiveness of the device, or major changes or modifications in the intended use of the device (21 CFR 807.81(a)(3)).

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