Medical Device Regulation

Nov 27, 2018
The Food and Drug Administration intends to finalize guidance early next year on a new approach to its 510(k) program for pre-market review of medical devices.
Nov 5, 2018
The AHA opposes tariffs that have been imposed on medical equipment and medical products imported from China that are used in hospitals, as well as potential tariffs under consideration that would impact the health care field.    
Dec 17, 2019
The Food and Drug Administration Friday cleared for marketing in the U.S. the first fully disposable duodenoscope.
Oct 25, 2019
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.
Sep 30, 2019
The Food and Drug Administration last week updated 2017 draft guidance to clarify the categories of clinical and decision support software subject to FDA oversight under the 21st Century Cures Act based on risk.
May 2, 2019
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.
Apr 24, 2019
The Food and Drug Administration today proposed reclassifying surgical staplers for internal use as moderate-risk rather than low-risk medical devices.
Mar 12, 2019
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.
Oct 17, 2018
The Food and Drug Administration today issued draft guidance that provides recommendations to the medical device industry on cybersecurity considerations for device design, labeling and documentation that the FDA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…