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FDA announces two pilot projects for improving ways to trace sources of foodborne illness; FDA will solicit stakeholder input in designing and implementing the pilots

Sidley Austin LLP
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USA
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September 15 2011

On September 7, 2011, the U.S. Food and Drug Administration (FDA) announced that it is moving forward with two pilot projectsone for processed foods and the other for producedesigned to help the agency and the food industry, including farms, restaurants, and grocery stores, more rapidly and effectively trace products back to a contamination source during outbreaks of foodborne illness

FDA draft guidance on mobile apps signals increased regulatory oversight

Sidley Austin LLP
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USA
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July 27 2011

On July 20, 2011, the U.S. Food and Drug Administration (FDA) issued draft guidance identifying the mobile device applications“apps”the agency plans to regulate as medical devices

New draft guidance on companion diagnostics signals new responsibilities for pharma and dx companies and clinical laboratories

Sidley Austin LLP
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USA
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July 26 2011

On July 14, U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance on In Vitro Companion Diagnostic Devices

FDA reorganization furthers pro-enforcement agenda, reflects global focus

Sidley Austin LLP
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USA
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July 18 2011

On July 13, 2011, Commissioner of Food and Drugs Dr. Margaret A. Hamburg announced a reorganization to create new “directorates” overseeing the core functions and responsibilities of the agency

FDA shift on diagnostics lays groundwork for regulation of lab-developed tests global life sciences - U.S. FDA update

Sidley Austin LLP
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USA
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July 15 2011

On July 12, 2011, FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) announced plans to down-classify and exempt from Section 510(k) premarket notification a range of in vitro diagnostic and radiology device types

New FDA draft guidance holds IVD manufacturers responsible for clinical use of ROUIUO products

Sidley Austin LLP
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USA
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June 16 2011

In a new proposed guidance, FDA has signaled its intention to shift responsibility for the use of certain medical devices from customers to manufacturers, based on an expansive and legally questionable presumption of “intent.”

FDA issues final rule classifying MDDSs as Class I medical devices

Sidley Austin LLP
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USA
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February 21 2011

On February 15, 2011, the U.S. Food and Drug Administration (FDA) published a final rule that classifies Medical Device Data Systems (MDDSs) as Class I devices, or low-risk devices, making them exempt from pre-market review but still subject to general controls, including design controls (notably, software design validation and verification) in the Quality System Regulation (QSR

FDA clears diagnostic application for mobile devices

Sidley Austin LLP
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USA
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February 11 2011

On February 4, 2011, the Food and Drug Administration (FDA) cleared the first mobile diagnostic radiology application for the iPhone and iPad

GAO report on food labeling might signal renewed FDA resistance to qualified health claimsglobal life sciences: US-FDA update

Sidley Austin LLP
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USA
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January 24 2011

On January 14, 2011, the U.S. Government Accountability Office (GAO) issued a report entitled, “Food Labeling: FDA Needs to Reassess its Approach to Protecting Consumers from False or Misleading Claims,” regarding the use of qualified health claims and structurefunction claims for food products

FDA announces plans for 510(k) reform and plans to issue key guidance in 2011

Sidley Austin LLP
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USA
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January 21 2011

On January 19, 2011, FDA released its plan of action for improving the 510(k) program, the most common review pathway for medical devices

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