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Validity : 22nd Apr'24 to 02nd May'24
Deciding When to Submit a 510(k) for a Change to an Existing Device - FDA’s Final Guidance
Session 1:
- Changes made with intent to affect device safety & effectiveness
- Initial Risk Based Assessment
- Use of Risk Management
- The role of validation & verification to determine whether a change could significantly affect device safety and effectiveness
- Evaluating simultaneous changes to determine whether submission of a new 510(k) is required
- Appropriate comparative device and cumulative effect of changes
- Substantial equivalence determination
Session 2:
- Is it a change in the indications for use statement
- Does the change add or delete a contra-indication
- Is it a change in warnings or precautions
- Could the change affect the directions for use of the device
Session 3:
- Is the device an in vitro diagnostic device
- Is it a control mechanism, operating principle, or energy type change
- Is it a change in sterilization, cleaning, or disinfection
- 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
- Could the change significantly affect the performance or biocompatibility of the device
- Is there a change in packaging or expiration dating
- Is the same method or protocol, as described in a previously cleared 510(k), used to support the change
- Is it any other change in design (e.g., dimensions, performance specifications, wireless communication, components or accessories or the patient/user interface)
Session 4:
- Is the device an in vitro diagnostic device
- Is this a change in material type, material formulation, chemical composition or the material’s processing
- Will the changed material directly or indirectly contact body tissues or fluids
- Does a risk assessment identify any new or increased biocompatibility concerns
- Has the manufacturer used the same material in a similar legally marketed device
- Could the change affect the device’s performance specifications
Session 5:
- Does the change alter the operating principle of the IVD
- Is the change identified in a device-specific final guidance or classification regulation
- Does a risk-based assessment of the changed device identify any new risks or significantly modified existing risks
- Do design verification and/or validation activities produce any unexpected issues of safety or effectiveness
Session 6:
- Likelihood or probability of occurrence of harm
- Severity of harm
- Device effectiveness
Overview of the webinar
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)).
This presentation, will aid manufacturers of medical devices who intend to modify a 510(k)-cleared device or a preamendments device subject to 510(k) (i.e., “existing devices”) during the process of deciding whether the modification exceeds the regulatory threshold of 21 CFR 807.81(a)(3) for submission and clearance of a new 510(k).
Who should attend?
- Quality Managers
- Quality Engineers
- Regulatory Affairs
- Small Business Owners
- GxP
- Consultants
- Quality VPs
- IT VPs
- Lab Directors
- Scientists
- FDA Investigators
- Other Regulatory Agency Investigators
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.
Faculty - Mz.Angela Bazigos
Angela Bazigos, is the CEO of Touchstone Technologies, Inc. She has 40 years of experience working in hospitals and Pharma industry. Her background includes companies like Roche, Novartis, Genentech and PricewaterhouseCoopers in GLP, GCP, GMP, Medical Device and Data Integrity Roles. She has held positions such as Chief Compliance Officer, QA Director and has acted on behalf CEO for communications with FDA.
Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to Life Science Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediation following action by the FDA. Has contributed to prototyping of 21 CFR 11 & CSV before promulgation to industry.
Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She holds a patent in speeding up software validation. She has been on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and is now on the Stanford Who’s Who Registry for contributions to the Life Sciences industry.