Life Sciences Newsbriefs: Week of August 9, 2010
Mondaq Business Briefing › United States Law Articles in English (2010)
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Life Sciences Newsbriefs: Week of August 9, 2010
CONTENTS:
Medical Devices Drugs & Biologics Biotech Food & Dietary Tobacco Medical Devices FDA releases proposals to update device approval process The FDA on Tuesday released a set of proposals with the aim of clarifying which devices can use the 510(k) approval process and when medical evidence is mandatory for approval. Advanced Medical Technology Association President and CEO Stephen J. Ubl said the recommendations "could result in a significant disruption to a program that has served patients well for more than 30 years." The agency is also proposing a Class IIb category of devices, which would include drug infusion pumps. FDA reopens comment period for neurological device reclassification The FDA has decided to reopen the period for accepting public feedback on a proposal to reclassify certain types of neurological and physical medicine devices from Class III, or high-risk, to Class II, or medium-risk. The agency has set a Sept. 7 deadline for public comments. Justice Department to file complaint in kickback suit against device firm The U.S. Justice Department said it plans to file a complaint by the end of this month in connection with a lawsuit lodged by a former St. Jude Medical employee against the device firm concerning the alleged use of medical research to pay kickbacks to doctors. St. Jude Medical said it opposes the agency's motion "and will vigorously defend against the allegations in the lawsuit." Senators introduce bi...See the full content of this document
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