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Nov 8, 2024 | 
morganlewis.com | Jacqueline R. Berman |Michele L. Buenafe |Rebecca Dandeker |Dennis Gucciardo
The reelection of former President Donald Trump, coupled with Republicans gaining the Senate majority and poised to gain the House majority, has prompted many in the life sciences industry to question how this political shift may impact the regulation of drugs, devices, and other life sciences products by FDA and related regulators.
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Oct 11, 2024 | 
jdsupra.com | Michele L. Buenafe |Dennis Gucciardo
With the February 2, 2026 compliance deadline approaching, medical device manufacturers must prepare for FDA’s updated regulations. The new Quality Management System Regulation (QMSR) will replace the existing Quality System Regulation (QSR), aligning with ISO 13485:2016. The transition may bring significant change to manufacturers not already compliant to ISO 13485:2016. On February 2, 2026, medical device manufacturers must fully comply with FDA’s revamped regulations at 21 C.F.R. Part 820.
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Oct 10, 2024 | 
morganlewis.com | Dennis Gucciardo |Michele L. Buenafe
With the February 2, 2026 compliance deadline approaching, medical device manufacturers must prepare for FDA’s updated regulations. The new Quality Management System Regulation (QMSR) will replace the existing Quality System Regulation (QSR), aligning with ISO 13485:2016. The transition may bring significant change to manufacturers not already compliant to ISO 13485:2016. On February 2, 2026, medical device manufacturers must fully comply with FDA’s revamped regulations at 21 C.F.R. Part 820.
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Sep 24, 2024 | 
morganlewis.com | Michael Abernathy |Stephen Altieri |Louis W. Beardell |Jacqueline R. Berman |Olga Berson |Christopher J. Betti | +23 more
NEW YORK, September 24, 2024: Morgan Lewis has received 13 practice rankings and 27 individual lawyer recognitions in the 2024 edition of Legal Media Group’s (LMG) LMG Life Sciences guide, an annual guide that honors law firms and lawyers for outstanding work in life sciences.
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May 22, 2024 | 
jdsupra.com | Michele L. Buenafe |Dennis Gucciardo |Angela Silva |Ângela Silva
While the US Food and Drug Administration’s recently issued Final Guidance on Remanufacturing of Medical Devices provides clarity and attempts to reign in certain activities, the agency continues to defer enforcement for servicing performed by independent third parties. The FDA issued its final guidance document on Remanufacturing of Medical Devices (Final Guidance) on May 10, 2024 to provide clarification on the difference between device “remanufacturing” and “servicing” activities.
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May 22, 2024 | 
morganlewis.com | Michele L. Buenafe |Dennis Gucciardo |Angela Silva |Ângela Silva
While the US Food and Drug Administration’s recently issued Final Guidance on Remanufacturing of Medical Devices provides clarity and attempts to reign in certain activities, the agency continues to defer enforcement for servicing performed by independent third parties. The FDA issued its final guidance document on Remanufacturing of Medical Devices (Final Guidance) on May 10, 2024 to provide clarification on the difference between device “remanufacturing” and “servicing” activities.
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May 14, 2024 | 
law360.com | Michele L. Buenafe |Dennis Gucciardo
By Michele Buenafe and Dennis Gucciardo (May 14, 2024, 3:19 PM EDT) -- The U.S. Food and Drug Administration on April 29 announced its final rule on laboratory-developed tests. This move marks the beginning of the end of the FDA's broad and long-established enforcement discretion policy for tests, which are known as LDTs and are mostly not expected to meet the premarket or post-market regulatory requirements.... Law360 is on it, so you are, too.
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May 6, 2024 | 
morganlewis.com | Michele L. Buenafe |Dennis Gucciardo
The US Food and Drug Administration (FDA) on April 29, 2024 announced its Final Rule on laboratory-developed tests (LDTs). This marks the beginning of the end of FDA’s broad and long-established enforcement discretion policy for LDTs, under which most LDTs were not expected to meet the premarket or postmarket regulatory requirements.
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May 6, 2024 | 
lexology.com | Michele L. Buenafe |Dennis Gucciardo
The US Food and Drug Administration (FDA) on April 29, 2024 announced its Final Rule on laboratory-developed tests (LDTs). This marks the beginning of the end of FDA’s broad and long-established enforcement discretion policy for LDTs, under which most LDTs were not expected to meet the premarket or postmarket regulatory requirements.
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Feb 12, 2024 | 
jdsupra.com | Michele L. Buenafe |Dennis Gucciardo |Maria Kalousi-Tatum
The US Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health recently announced its intention to reclassify certain high-risk in vitro diagnostic devices (IVDs) as moderate risk, a potential first step as the agency prepares to oversee laboratory-developed tests (LDTs).
