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I&L Committee Topic: Ethylene Oxide (EtO) Sterilization
AHRMM Issues & Legislative (I&L) Committee identifies, reviews and follows the regulatory, environmental,
AHRMM Comment Letter to FDA RE: “Modernizing FDA’s Data Strategy”
In September 2019, FDA announced its Technology Modernization Actio
FDA approves first disposable duodenoscope
The Food and Drug Administration Friday cleared for marketing in the U.S. the first fully disposable duodenoscope.
FDA: Sterilization facility closures could prompt future device shortages
The Food and Drug Administration today alerted the public to growing concern about the potential for medical device shortages as facilities that sterilize devices using ethylene oxide close.
FDA updates guidance on regulating digital health tools
The Food and Drug Administration last week updated 2017 draft guidance to clarify the categories of clinical and decision support software subject to FDA oversight under the 21st Century Cures Act based on risk.
CMS to speed request process for new drug, device payment codes
The Centers for Medicare & Medicaid Services will increase the number of opportunities to apply for Healthcare Common Procedure Coding System Level II codes from once per year to quarterly for new drugs and semiannually for new medical devices.
FDA proposes regulatory changes to improve surgical stapler safety
The Food and Drug Administration today proposed reclassifying surgical staplers for internal use as moderate-risk rather than low-risk medical devices.
CMS outlines planned changes to competitive bidding program for 2021
The Centers for Medicare & Medicaid Services last week announced planned changes to the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Competitive Bidding Program for 2021.
FDA issues draft guidance on cybersecurity for medical device industry
The Food and Drug Administration today issued draft guidance that provides recommendations to the medical device industry on cybersecurity considerations for device design, labeling and documentation that the FDA recommends be included in premarket submissions for medical devices with cybersecurity risk.