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FDA Publishes Final Rule to Amend and Reduce Regulatory Burden on Outdated and Duplicative Requirements as They Pertain to Radiological Health Regulations

FDA Law Blog

By Véronique Li, Senior Medical Device Regulation Expert & Allyson B. Mullen — Sections of the radiological health regulations have been updated with the goal of lessening regulatory burdens. The regulations contain many requirements that are over 30 years old. 360ii, 360kk(a)(1), and 360nn(b))).

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FDA drops PreCert report, new digital health guidances

pharmaphorum

The US FDA’s Center for Devices and Radiological Health (CDRH) dropped a bevy of new digital health guidances and reports today and yesterday, providing some long-awaited clarity and peeks into the agency’s future plans. . The Pre-Cert pilot report. O’Leary said. New SaMD guidance and more.

Radiology 135
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AI/ML-enabled Medical Devices Have Everyone’s Attention, Including FDA’s

FDA Law Blog

Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products. Just a day earlier, FDA’s Center for Devices and Radiological Health (CDRH) released a list of the guidance documents the Center intends to publish in the upcoming 2024 fiscal year.

Radiology 119
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14th Asia Pacific Symposium on Cochlear Implant and Related Sciences Set to Convene in Seoul — Featuring HP&M’s Dr. Philip Won

FDA Law Blog

Won will share his expertise and insights on the intricacies of the United States Food and Drug Administration (FDA) regulations pertaining to medical devices, with a special focus on class II and class III hearing devices.

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Google gives ex-FDA digital health head Bakul Patel strategic role

pharmaphorum

FDA veteran Bakul Patel has joined Google as its new senior director of global digital health strategy, ending a stint at the regulator that lasted more than 13 years. Current FDA Commissioner Robert Califf spent some time as an advisor to Google parent Alphabet after his earlier stint at the head of the regulator. Bakul Patel.

Radiology 139
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FDA Updates the Regulatory Definitions of Certain Software Types for Consistency with 21st Century Cures Act Exclusions

FDA Law Blog

To date, FDA had not updated its classification regulations, the FDA regulations defining categories of devices and outlining the applicable regulatory controls, to carve out the categories of software devices excluded from the device definition by the Cures Act. Certain types of clinical decision-support software. 21 C.F.R.).

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Philips DreamStation 2 CPAP Machines Get FDA Safety Warning

XTalks

We will continue to monitor the company’s handling of this, among other safety issues, to ensure they take appropriate steps to mitigate the risk to patients,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in the FDA’s news release. “We