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Is ASCA worth it? FDA’s Accreditation Scheme for Conformity Assessment

FDA Law Blog

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.

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FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples

The Pharma Data

director of the FDA’s Center for Devices and Radiological Health. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. for the next public health emergency.”. Source link: [link].

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FDA Warns of Risks Associated with Non-Invasive Prenatal Screening Tests

The Pharma Data

director of the FDA’s Center for Devices and Radiological Health. While LDTs are medical devices under the Federal Food, Drug, and Cosmetic Act, the FDA has had a general policy of enforcement discretion for most LDTs since the Medical Device Amendments were enacted in 1976. Source link: [link].

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FDA Provides Update on Recall of Certain Philips Respironics Breathing Assistance Machines

The Pharma Data

director of the FDA’s Center for Devices and Radiological Health. “We An FDA investigator’s list of examination compliances doesn’t constitute a final FDA determination of whether any condition is in violation of the Federal Food, Drug, and Cosmetic Act or any of its enforcing regulations. Source link: [link].

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The Medical Metaverse Digest for June 30

Intouch Solutions

47% of those had made in-game purchases, and 37% had purchased virtual cosmetic items. And 79% of their 3,000 survey respondents said that they had already – not someday! made a purchase inside a metaverse. 33% had purchased real-world items offered through virtual platforms. Pharma companies in the metaverse?

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FDA Issues Unsupported Safety Warning Regarding Surgical Robots for Cancer Treatment

FDA Law Blog

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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FDA Permits Marketing of New Device Designed to Reduce Sleep Disturbance Related to Nightmares in Certain Adults

The Pharma Data

director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health. PTSD is a disorder that develops in some people who have experienced a shocking, scary, or dangerous event. . . SOURCE U.S.