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Stunning Changes in FDA's Software Regulation  

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Online Compliance Panel   

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Regulatory affairs directors, Software designers / specification developers

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Training Course Syllabus:


Objectives of the Presentation

Identify software that is no longer regulated by the FDA
Identify FDA guidance documents that will be revised or withdrawn
Identify mobile apps exempt from FDA regulation
Identify premarket shortcuts for software 510(k) clearance
Identify recall reporting options for cybersecurity problems
Highlight the FDAs Digital Health initiative

Why Should you Attend

FDAs regulation of software provides major relief to firms involved with software, especially low risk software. Firms should be re-evaluated the software they market to determine if the regulatory relief applies to the software they market. Are you developing your risk assessment? Criteria so you can justify saying, (1) "My software is not regulated" (2) "Does my firm meet the criteria to clear its own software 510(k)s?" or (3) "My software qualifies as digital health software." These are questions that require work now so that you reap the rewards going forward.

Areas Covered

21st century cure act impact
Software no longer under FDA jurisdiction
Changes in premarket requirements
Voluntary controls short cuts
Post market reporting options
Digital Health Initiative - FDA clearance not required

Who will Benefit

Regulatory affairs directors, Software designers / specification developers, Production managers, Quality assurance directors, In-house legal counsel, Importers of software-based devices, Software engineers, information technology managers, Third party software services, Regulatory Affairs Managers, Healthcare institution risk managers, Complaint investigation teams, Quality assurance directors

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