CDRH’s Shuren Calls For ‘Reset’ Of FDA Medtech Initiatives
Programs disrupted by COVID-19 would be restarted in 2021 to guide developers on clinical decision support software, produce safe OTC hearing aids
US FDA device center director Jeff Shuren wants to hit the reset button for initiatives delayed by agency’s responses to the coronavirus pandemic.
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Two new rules put forward by the US HHS could have a chilling effect on future guidance documents and regulations drafted by the FDA and the 27 other agencies and offices the HHS oversees, a policy expert says. This and other stories topped our list of most-read US regulation, policy, quality control and compliance articles in December.
The US agency released three new guidance documents on 10 December detailing how certain devices can be cleared through a safety and performance pathway.
The US FDA’s Elizabeth Miller says the agency won’t release a draft of its revised Quality System Regulation until sometime next year. The FDA has been harmonizing its QSR with international quality systems standard ISO 13485:2016 since 2018.