Tag

draftguidance
FDA issued the draft guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program” June 7, 2018. Note that there are a variety of types of Q-submissions and they do not need to be tied to a specific planned 510(k) or other premarket submission. Also note that they are not meant to...
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FDA issued a draft guidance dated April 27, 2018 titled: “Multiple Function Device Products: Policy and Considerations.”  This guidance expands on when and how FDA intends to assess the impact of other functions that are not the subject of a premarket review on the safety and effectiveness of a device function subject to FDA review....
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FDA issued a draft guidance for comment: Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Contains Nonbinding Recommendations Draft – Not for Implementation Equivalence through Performance Criteria. The outline shows a Section 17 for software information. The outline can be viewed here.
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On Dec. 14, 2017, the FDA released a Draft guidance dated Dec. 15, 2017 “The Least Burdensome Provisions: Concept and Principles.” This guidance discusses FDA’s intent and approach to applying Least Burdensome Principles to the total product lifecycle for medical devices based on requirements in FDAMA (Public Law 105-115), the FDA Safety and Innovation Act...
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On Dec. 8, 2017, the FDA released the draft guidance, “Clinical and Patient Decision Support Software.” This guidance addresses software for decision support in two categories: one used by Healthcare Professionals, the other used personally by patients and non-health professionals. It provides FDA interpretation of which types of Decision Support Software do not meet the...
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On Dec. 8, 2017, the FDA released draft guidance, “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act.” This guidance discusses software functions in relation to the modified device definition in the 21st Century Cures Act and the criteria for interpreting if and how medical software will or...
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The FDA published a draft guidance, “Breakthrough Devices Program Draft Guidance for Industry and Food and Drug Administration Staff,” on October 25, 2017. The full guidance is at the link provided. This supersedes the Expedited Access Pathway (EAP) introduced in 2015 and the Priority Review Program. The Breakthrough Devices Program is a voluntary program for...
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