Enerxen

Enerxen
Enerxen

CDRH

Software Security Standards

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November 20th, 2023 – Mitchell Gorthy FDA recognizes three new international medical device software security standards The FDA and CDRH recognized three new medical device software security standards. ANSI/AMMI 2700-2-1 and ANSI/AMMI SW96 developed by American National Standards Institute (ANSI) and The Association for the Advancement of Medical Instrumentation (AAMI) are among them. ISO/IEC/IEEE 29119-1 … Read more

CDRH: Updated Draft Guidances – 510(k) Program

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Man with clipboard. with FDA and Enerxen company logo in forefront.

October 30th, 2023 – Written by Mitchell Gorthy Summary On October 26th, the FDA’s Center for Devices and Radiological Health (CDRH) updated draft guidances to modernize their 510(k) program. Employees from the CDRH’s Office of Product Evaluation and Quality gave brief overviews of each draft guidance. Regulatory Advisor, Megha Reddy, explained “Best Practices for Selecting … Read more