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newguidance
Devices that do not meet the criteria for the Breakthrough Devices Program may have a new option under the Safer Technologies Program for Medical Devices (STeP). Read our previous post on the the Breakthrough Devices Program here: FDA Breakthrough Devices Program Draft Guidance. SteP is a voluntary program for certain medical devices that are “reasonably...
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FDA has posted their FY 2019 Proposed Guidance Development list with priorities. A link is provided below but here is the “A” list items: Final Guidance Topics Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions Unique Device Identification: Policy Regarding Compliance Dates for Class...
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Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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