Device Single Audit Program News Today

On April 17, the Food and Drug Administration's Center for Devices and Radiological Health (CDRH) issued its 2024 safety report. As an update to their 2018 Medical Device Safety Action Plan...

New guidance to advance medical device safety, regulatory oversight, and innovation On April 17, the Food and Drug Administrations Center for Devices and Radiological Health ...

Vaccines manufacturer Serum Institute of India (SII) on Friday said it is acquiring 20 per cent stake in IntegriMedical, to advance needle-free injection system technology. IntegriMedical has developed a US patented needle-free Injection System (N-FIS) that utilises high-velocity jet stream using

IntegriMedical has developed a US patented needle-free Injection System (N-FIS) that utilises high-velocity jet stream using mechanical power to effectively and consistently administer biologics and drugs, Serum Institute of India (SII) said in a statement.

Motiva(R), the global leader in silicone gel-filled implants for breast aesthetics and reconstruction, is delighted to announce the official launch ofJOY by Motiva(R),the latest innovation in silicone breast augmentation now available in Thailand.

PRESS RELEASE

On February 2, 2024, the US Food and Drug Administration (FDA) published a much-awaited final rule: the Quality Management System Regulation (QMSR). By issuing this rule, FDA amended...

More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule.

After a long wait, the U.S. Food and Drug Administration (FDA) recently published a Final Rule to harmonize the Quality System Regulation (QSR) codified at 21 C.F.R. Part 820...

On January 21, 2024, the FDA issued a final rule amending its Quality System (QS) regulations under 21 CFR Part 820, which addresses current good…