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FDA Publishes Final Rule to Amend and Reduce Regulatory Burden on Outdated and Duplicative Requirements as They Pertain to Radiological Health Regulations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

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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.

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

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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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Finalizing the Quality Management System Regulation – A High Priority for End of 2023

FDA Law Blog

By Véronique Li, Senior Medical Device Regulation Expert — Earlier this year, neither the Quality System Regulation (QSR) nor the Quality Management System Regulation (QMSR) were referenced in the semiannual regulatory agenda. According to the Unified Agenda, the proposed rule is in the final rule stage.

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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.

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FDA launches Digital Health Center of Excellence

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Housed within the agency’s Center for Devices and Radiological Health, the DHCoE is part of a wider strategy to encourage development of digital health products and therapeutics. Its remit will be to support and encourage developers, including newcomers to healthcare, to translate new technology into usable products.

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MIOTIFY platform for digital health products clears AZ road test

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Teasing out complex relationships within data lies at the heart of any digital health intervention, but finding the algorithms to do so reliably – and making sure they will be acceptable to regulators – can be a challenge. The algorithms used in healthcare are becoming more complex as well. The next steps?