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The agency “has not specifically evaluated implementation of the least burdensome requirements,” according to the Government Accountability Office. Read More
“We do not want to imply that all other decisions of the agency that do not fall within section 517A of the FD&C Act are not significant,” a new proposed rule states. Read More
CDRH released a three-year plan outlining three priorities to focus on: employee engagement, streamlining of processes, and building “collaborative communities.” Read More
“We aim to have more than 50 percent of manufacturers of novel technologies…intend to bring their devices to the U.S. first or in parallel with other major markets by December 31, 2020,” said CDRH Director Jeff Shuren. Read More
CDRH is looking to enroll a total of nine participants in its new pilot program aimed at identifying best practices for quality product manufacturing. Read More
The FDA said in a new draft guidance a “least burdensome” approach should be applied throughout the medical device total product lifecycle, rather than just in premarket activities. Read More
The FDA finalized a more detailed “leapfrog guidance” on additive manufactured, or 3D-printed, medical technologies, outlining its latest thinking on technical considerations. Read More
Facilities in India, Lithuania and Texas drew warnings from the FDA for a variety of noncompliances, including inadequate validations, designs and device history records. Read More
The recent ransomware attacks in the U.S. healthcare industry have highlighted the need for increased product security for medical devices, the American Hospital Association said in a letter to the FDA. Read More