In Brief: MDR variances
This article was originally published in The Gray Sheet
MDR variances: FDA's Office of Surveillance and Biometrics issues four variances to address difficulties relating to formatting manufacturer report numbers required on MedWatch form 3500A under the agency's medical device reporting rule. A July 16 letter sent to device firms says the variances apply to situations in which: "several reporting sites share the same registration number and also share the number with a manufacturing site at the same location that makes devices for the reporting sites"; "reporting sites have different registration numbers but share the same manufacturing site"; "multiple manufacturing sites at the same location share the same registration number"; and "a device is manufactured at more than one site." For the first three cases, companies can request that FDA issue an "assigned reporting number" in order to alleviate any report number confusion; in the remaining cases, if firms are unable to determine which manufacturing site produced a device involved in an adverse event, the company "may arbitrarily assign a manufacturing site using any method of assignment." For further information, contact OSB's Reporting Systems Monitoring Team at 301/594-2735...
You may also be interested in...
UK start-up Iceni Diagnostics has secured funding to develop its test for the live, intact SARS-CoV-2 virus and the UK government is evaluating a lateral flow device based on the technology for testing saliva samples as part of efforts to step up rapid testing in the country. See what Iceni’s CEO Rob Field said about it here.
The run-away US FDA advisory committee review of Biogen’s Alzheimer’s candidate was highly unusual. But like most things at the agency, not entirely unprecedented.
Trump Administration’s attempt to eliminate rebates in the US Medicare outpatient drug benefit program is the easiest and most certain item among the 11th hour pricing policy changes for the incoming Biden Administration to undo. But it still had a major impact on the dynamics of the drug pricing debate.