24 Questions
What type of software is exempt from the software guidance?
Software for which FDA has stated it does not intend to enforce compliance with applicable regulatory control
What should be done when there are multiple changes affecting labeling or hardware in addition to software?
Assess the changes using both guidances
What is required when adding a new mode to a software-only device?
Assessment of the change under the software modifications guidance
What is the purpose of the guiding principles in the guidances?
To provide essential principles for use of the documents
What type of changes would require the use of both software modifications and general modifications guidance?
Changes to software and hardware that affect the device's labeling
What is not addressed in the software guidance?
Software life cycle
What is required when adding a new mode to an infusion pump?
Assessment of the change under both guidances
What is the purpose of the guiding principles in the guidances?
To provide essential principles for use of the documents
What was the main reason for updating the flow charts?
To serve as a companion to the text
What does 'could significantly affect' refer to?
Key regulatory terms
Which devices are excluded from both guidances mentioned?
PMA devices and 510(k) exempt devices
What additional content was added to the appendix?
Documentation recommendations and examples
What does the general guidance apply to?
Non-software changes to software devices
What illustrates the complexity variation of documentation?
Documentation recommendations and examples in the appendix
What paradigm was added to the decision-making process for all changes?
Risk assessment paradigm
What ensures consistency between the two guidances?
Key principles underlying the decision paradigm
What must be done when a change could significantly affect a device's safety or effectiveness?
A new 510(k) must be submitted
How should multiple changes to a device be evaluated?
Individually first, then collectively
When determining if a particular change requires a new 510(k), what should you compare the changed device to?
The device as previously found to be substantially equivalent
What term is used to refer to the appropriate comparative device in the guidance document?
Original Device
What trigger requires the submission of a new 510(k) due to multiple changes to a device?
The cumulative effect of individual changes triggering the regulatory threshold
What must be ensured every time you make a change to a device, according to the guiding principles?
The modified device should be compared to the original device
What aspect does the next guiding principle after multiple changes specifically address?
Documentation requirements
What regulation requires that device changes be documented?
Quality system regulation
Study Notes
Key Updates and Improvements
- The flow charts have been updated to align with the text and provide added clarity on key regulatory terms such as "could significantly affect."
- The key principles underlying the decision paradigm have been updated, and changes have been made to the materials section.
- A large number of illustrative examples have been added to provide better understanding.
- An appendix with documentation recommendations and examples has been added to demonstrate how the complexity of documentation varies depending on the complexity of the device change.
Scope of Guidances
- Both guidances (general and software modifications) apply to legally marketed devices subject to 510(k) requirements.
- PMA devices and 510(k) exempt devices are outside the scope of both guidances.
- The general guidance applies to non-software changes to software devices or devices containing software.
Guiding Principles
- The regulation requires submission of a new 510(k) when a change could significantly affect safety or effectiveness.
- Both safety and effectiveness should be considered in evaluating a device's risk profile.
- A risk-based assessment should be performed as explained in Section E.
- When evaluating simultaneous changes, they should be assessed both separately and together.
- The cumulative effect of changes should be considered when determining whether a new 510(k) is required.
Comparative Device and Risk Assessment
- The original device is the device as previously found to be substantially equivalent in the most recently cleared 510(k).
- When making a change, the modified device should be compared to the original device.
- The cumulative effect of individual changes may trigger the regulatory threshold for submission, requiring a new 510(k).
Documentation Requirements
- Devices changes must be documented in compliance with the quality system regulation.
- The scope and type of documentation may vary depending on the complexity of the device change.
- The process of documenting decisions should be established as part of the quality system.
Software Guidance
- The software guidance does not apply to software for which FDA has stated that they do not intend to enforce compliance with applicable regulatory control.
- The software guidance does not address other software-related concepts like the software life cycle, documentation, or validation principles.
- When multiple changes affect labeling or hardware in addition to software, both guidances should be used, and if either guidance leads to a new 510(k) conclusion, submission of a new 510(k) is likely required.
This quiz assesses understanding of regulatory terms and decision-making principles, including the interpretation of key phrases like 'could significantly affect'.
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