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FDA Law Blog
JUNE 28, 2023
Baumhardt, Senior Medical Device Regulation Expert & Philip Won — The Center for Devices and Radiological Health’s (CDRH) Standards and Conformity Assessment Program (S-CAP) encourages medical device sponsors to use FDA-recognized voluntary consensus standards in their product submissions.
FDA Law Blog
OCTOBER 14, 2021
Mullen — In recent years, for novel robot assisted surgery (RAS) devices, FDA’s Center for Devices and Radiological Health (CDRH) has taken the approach of clearing RAS devices for specific indications for use. By Jeffrey K. Shapiro & Allyson B. Gone are the days of tool type indications for this type of device. 21 U.S.C. §
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Intouch Solutions
JUNE 30, 2022
47% of those had made in-game purchases, and 37% had purchased virtual cosmetic items. If major pharmacies like CVS are planning for the metaverse, pharma manufacturers should be fast followers! And 79% of their 3,000 survey respondents said that they had already – not someday! made a purchase inside a metaverse.
The Pharma Data
NOVEMBER 12, 2021
director of the FDA’s Center for Devices and Radiological Health. “We In response to the recall, the FDA lately conducted an examination of a Philips Respironics’ manufacturing installation to determine what may have caused or contributed to the froth issues and assess adherence to the agency’s conditions for quality manufacturing.
The Pharma Data
NOVEMBER 17, 2020
director of FDA’s Center for Devices and Radiological Health. Lucira Health, the test manufacturer, has also developed box labeling, quick reference instructions and health care provider instructions to assist with reporting. . . . .
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