Rx REPORT

FDA Issues Final Guidance Postmarket Management of Cyber Security in Medical Devices

5 January 2017
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Summary

FDA Issues Final Guidance on Quality Agreements

3 January 2017
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Summary

FDA Public Notification of Emerging Postmarket Medical Device Signals

3 January 2017
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Summary

MHRA announced it signed a Memorandum of Understanding (MOU) with its counterpart body in India

27 December 2016
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Summary

FDA Guidance: eCopy Program for Medical Devices

27 December 2016
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Medical Device User Fee and Modernization Act

27 December 2016
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Summary

FDA CDRH Strategic Priorities 2016-2017

27 December 2016
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Summary

EU Safety Features – Q&A Document Published by the European Commission

27 December 2016
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Summary

Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers

27 December 2016
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Summary

International Council for Harmonization – FDA Regional Public Meeting and Consultation

27 December 2016
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