CDRH Sets Fiscal Year 2017 Guidance Priorities
The Association for the Advancement of Medical Instrumentation (AAMI) is reporting that the Center for Devices and Radiological Health (CDRH) has released a list of 12 final guidance documents and four drafts that it intends to publish during fiscal year 2017. The center, which is the arm of the Food and Drug Administration (FDA) that regulates the medical device industry, also developed a second list of guidance items that will be developed as “resources permit.” The so-called “A-list” covers several hot topics in the industry, including the use of real-world evidence to support regulatory decision making, which is also a regulatory science priority for 2017, as well as device cybersecurity, interoperability, and the use of benefit-risk factors. However, with uncertainty surrounding President-elect Donald Trump's pick for FDA commissioner and his administration’s healthcare policies in general, it's unclear whether these topics will remain priorities and how they might play out.
To read further from AAMI, CLICK HERE.
Source: AAMI
The Sterile Processing Conference Survival Guide: How to Make the Most of Your Next Event
March 25th 2025From expert speakers to cutting-edge tools, sterile processing conferences, like the 2025 HSPA Annual Conference and the SoCal SPA's Spring Conference, offer unmatched opportunities to grow your skills, expand your network, and strengthen your department's infection prevention game.
Redefining Material Compatibility in Sterilization: Insights From AAMI TIR17:2024
March 24th 2025AAMI TIR17:2024 provides updated, evidence-based guidance on material compatibility with sterilization modalities. It offers essential insights for medical device design and ensures safety without compromising functionality.
The Latest on CLABSIs and CAUTIs: Evidence-Based Approaches for Infection Prevention
February 27th 2025Health care–associated infections like CLABSIs and CAUTIs threaten patient safety. Learn evidence-based strategies, new technologies, and prevention protocols to reduce these infections and improve outcomes.
