Regulatory Compliance: Key Terms and Decision Paradigm

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'.