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Results: 1-10 of 18

Medical device user fee rates for FY 2013

  • Reed Smith LLP
  • -
  • USA
  • -
  • July 31 2012

On July 31, 2012, the FDA published the fee rates and payment procedures for medical device user fees for FY 2013

FDA guidance addresses genotoxicity testing and data interpretation for human drugs

  • Reed Smith LLP
  • -
  • USA
  • -
  • July 16 2012

The FDA recently published a guidance document entitled "S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use."

FDA proposes unique device identification system for medical devices

  • Reed Smith LLP
  • -
  • USA
  • -
  • 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
  • -
  • 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
  • -
  • USA
  • -
  • 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The FDA has released draft guidance entitled “Drug Safety InformationFDA’s Communication to the Public,” which updates and revises March 2007 guidance on this issue

FDA draft guidance on classifying significant postmarket drug safety issues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
  • -
  • USA
  • -
  • March 29 2012

The FDA has released draft guidance entitled “Classifying Significant Postmarket Drug Safety Issues.”

FDA report on exploratory program to increase access to agency compliance and enforcement data

  • Reed Smith LLP
  • -
  • USA
  • -
  • February 10 2012

On January 31, 2012, FDA released a new transparency report regarding its compliance and enforcement data

Final rule regarding labeling requirements for products held in strategic national stockpile

  • Reed Smith LLP
  • -
  • USA
  • -
  • February 10 2012

On February 6, 2012, the FDA adopted as a final rule, without change, the interim final rule from December 28, 2007 that permitted FDA Center Directors to grant exceptions or alternatives to certain regulatory labeling requirements applicable to human drugs, biological products, or medical devices that are or will be included in the Strategic National Stockpile

FDA provides draft guidance on evaluating substantial equivalence in premarket notifications

  • Reed Smith LLP
  • -
  • USA
  • -
  • December 29 2011

On December 27, 2011, FDA released draft guidance entitled “Draft Guidance for Industry and Food and Drug Administration Staff; The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications 510(k)”

FDA draft guidance on artificial pancreas device systems, hepatitis B screening of bloodblood components

  • Reed Smith LLP
  • -
  • USA
  • -
  • 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.”