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Class I Recalls for Philips MRI Coils and Inspire Sleep Apnea DeviceRegulatory Affairs
The potential for radiofrequency coils heating up during an MRI scan has led the FDA to deem Philips’ recall of its Sense XL Torso Coils as Class I, as overheating could cause thermal injury. Read more
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Three Device Areas Added to CDRH’s Device-Advancing TAP ProgramRegulatory Affairs
CDRH launched the TAP Pilot in 2023 as a commitment under the MDUFA V reauthorization. Read more
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FDA Publishes Draft Guidance on Using URRAs in Combo Product ApplicationsRegulatory Affairs
To help the drug and device development industries account for human factors (HF) in their combination product trials, the FDA is releasing draft guidance on employing use-related risk analysis (URRA), a risk management tool that supports the HF engineering process. Read more
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Regulatory Expert Weighs in on Impact of the LDT Final RuleRegulatory Affairs
Labs are concerned about burden of complying with premarket review requirements, expert says. Read more
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Deputy Secretary-General for ASEAN Political-Security Community receives Ambassador of Denmark to ASEANASEAN Main Portal
Deputy Secretary-General of ASEAN for ASEAN Political-Security Community, H.E. Dato’ Astanah Abdul Aziz, met with Ambassador of Denmark to ASEAN, H.E. Sten Frimodt Nielsen today. They touched on opportunities to augment the partnership through practical cooperation, both bilaterally and through the ASEAN-EU strategic partnership. Read more
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Secretary-General of ASEAN discusses ASEAN-Canada Strategic Partnership with Ambassador of Canada to ASEANASEAN Main Portal
Secretary-General of ASEAN, Dr. Kao Kim Hourn, today met with Ambassador of Canada to ASEAN Vicky Singmin, at the ASEAN Headquarters/ASEAN Secretariat. They discussed the preparations for the upcoming ASEAN-Canada Ministerial Meeting in Vientiane, Lao PDR on 26 July 2024, and exchanged views on Read more