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FDA proposes unique device identification system for medical devices
- Reed Smith LLP
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- USA
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- July 16 2012
On July 10, 2012, in response to requirements in legislation that passed Congress with broad bipartisan support, the Food and Drug Administration published a proposed rule that would require most medical devices distributed in the United States to carry a unique device identifier, or UDI, except where the rule provides for alternative placement of the UDI or provides an exception for a particular device or type of device (e.g., devices sold over-the-counter and low risk devices
FDA guidance on medical device pre-market approval
- Reed Smith LLP
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- USA
- -
- May 11 2012
The FDA has published guidance for medical device manufacturers that describes how the benefits and risks of certain medical devices are considered during pre-market review
FDA issues guidance update on communication to the public about drug safety
- Reed Smith LLP
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- USA
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- March 29 2012
The FDA has released draft guidance entitled “Drug Safety InformationFDA’s Communication to the Public,” which updates and revises March 2007 guidance on this issue
FDA draft guidance on classifying significant postmarket drug safety issues
- Reed Smith LLP
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- USA
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- March 29 2012
The FDA has released draft guidance entitled “Classifying Significant Postmarket Drug Safety Issues.”
FDA draft guidance on artificial pancreas device systems, hepatitis B screening of bloodblood components
- Reed Smith LLP
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- USA
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- December 13 2011
The FDA has issued draft guidance on “The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems.”
FDA proposes changes to Orphan Drug Regulations
- Reed Smith LLP
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- USA
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- October 21 2011
On October 19, 2011 the Food and Drug Administration published a proposed rule in the Federal Register that would amend the 1992 Orphan Drug Regulations issued to implement the Orphan Drug Act
FDA issues draft guidance to clarify de novo classification process
- Reed Smith LLP
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- USA
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- October 14 2011
On October 3, 2011, the FDA released draft guidance entitled “De Novo Classification Process (Evaluation of Automatic Class III Designation).”
FDA issues Strategic Plan for Regulatory Science
- Reed Smith LLP
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- USA
- -
- September 1 2011
On August 17, 2011, the FDA released its “Strategic Plan for Regulatory Science,” calling for a sweeping modernization of the science used in developing and evaluating products critical to the nation’s health, economy, and security
FDA issues draft guidance regarding design of pivotal clinical investigations for medical devices
- Reed Smith LLP
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- USA
- -
- August 16 2011
The Food and Drug Administration (FDA) issued draft guidance on August 15, 2011 to help researchers and manufacturers design better quality clinical studies in support of premarket approval applications for certain medical devices
FDA issues guidance and final rule regarding focused ultrasound stimulators for aesthetic use
- Reed Smith LLP
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- USA
- -
- July 26 2011
On July 20, 2011, the FDA issued both a final rule and a guidance document regarding the classification of Focused Ultrasound Stimulators for Aesthetic Use as Class II Special Control devices
Current Search
- Jurisdiction - USA
- Firm Name - Reed Smith LLP
- Workarea - Product Liability
- Workarea - Healthcare
- Author - Erin A. Janssen