*Developments: FDA (Archive 2018)

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Organization & Developments: FDA

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2018: Artificial Intelligence_AI software that helps doctors diagnose like specialists is approved by FDA
2018: Developing a Software Precertification_www.fda.gov
2018: Draft_Content of Premarket Submissions forwww.fda.gov
2018: FDA boosts medical device cybersecurity coordination with Homeland Security
2018: FDA issues policy to facilitate the use of electronic health record data in clinical investigations
2018: FDA launches accelerated review program for products needed by DoD - ARK Genomic Revolution Multi-Sector ETF (NYSEARCA:ARKG)
2018: FDA launches pilot program in support of complex trial designs for drugs and biologics – Endpoints News
2018: FDA picks eight medical device firms to help battle opioid crisis
2018: FDA plans ‘generational’ overhaul of medical device approvals to make way for new technology_510(k) pathway
2018: FDA to include cybersecurity ‘bill of materials’ in medical device premarket guidance
2018: FDA Unveils MITRE’s Medical Device Security Playbook
2018: FDA, DoD Sign MoU to Accelerate Availability of Medical Products for Military Servicemen
2018: FDA's 2019 budget request cites digital health; agency rolls out medical device initiative
2018: FDA’s Scott Gottlieb wants to use funding boost to create a Center of Excellence on Digital Health
2018: IDIQ Requirements for a Production Version of precisionFDA
2018: New FDA App Streamlines EHR Patient Data Collection for Researchers
2018: New market guidances, regulatory pathway change proposals close out 2018 for FDA
2018: Public Workshop - Fostering Digital Health Innovation: Developing the Software Precertification Program - January 30-31, 2018_fda

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