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How the FDA evaluates real world data (RWD) to determine if they are of sufficient quality to be used as real world evidence (RWE) in regulatory decision making for medical devices is the subject of an FDA draft guidance that will replace a previous guidance on the topic issued in 2017. Read More
Senators Dick Durbin (D-Ill.) and Richard Blumenthal (D-Conn.) have asked the Government Accountability Office (GAO) to conduct a review of the FDA’s oversight of medical device recalls, citing a massive increase in adverse event reports and recall events in the past decade. Read More
CDRH has teamed up with three more collaborative device initiatives, including an international effort to leverage the power of AI to improve medical device quality and patient health. Read More
This edition of Quick Notes looks across the pond at Europe’s new critical medicines list, reference labs for high-risk IVDs, guidelines for adverse reaction follow-ups and a tweaked website. Read More
The law, slated to take effect Jan. 1, 2024, requires Colorado health insurers to cap the amount for an epi-pen at $60 for a two-pack of injectors. Read More
Getinge’s recall of its Cardiohelp for problems with its emergency drive has been identified by the FDA as a Class I recall — the most serious type of recall as use of these devices may cause serious injuries or death. Read More
HHS’s fall unified agenda of proposed rules for the FDA includes a new rule that revokes two old rules that have either been superseded or do not reflect current agency practice, the agenda says. Read More
A survey conducted among attendees of Team NB’s second in vitro device regulation (IVDR) training seminar reflected the worrisome trend of foot-dragging among manufacturers in making an application to a Notified Body for approval of devices under the new EU medical device regulations. Read More
As the comment period closed Wednesday on a trio of FDA draft guidances covering data requirements for 510(k) device submissions, industry trade group AdvaMed expressed its clear concerns that the guidances exceeded the agency’s regulatory scope. Read More