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FDA Updates
        FDA Updates are published frequently.  Please check this page often.

 FDA UPDATE ARCHIVES 1999 -2008 CLICK HERE       

• FDA Update – Sept 8, 2010: Important Information on the Medical Device User Fee Rates for FY 2011
   
• FDA Update – Sept 8, 2010: Posting a Company’s Response to a Warning Letter
   
• FDA Update – September 1, 2010: Effective Date of Requirement for Premarket Approval for Four Class III Preamendments Devices
   
• FDA Update – August 23, 2010: Notice of Medical Device User Fee Rates for Fiscal Year 2011
    
• FDA update – August 19, 2010: Warning Letter issuance – How long before the FDA issues one?
   
• FDA Update - July 10, 2010: MDR follow up by FDA - FDA Outlines how they will review and Analyze Adverse Reports
   
• FDA Update – June 7, 2010: Report on FDA’s Initiative towards Safety of Patients Using Medical Devices at Home
   
• FDA Update - May 14, 2010: FDA jumps to Out Side Expert Consultant for company compliance Audits
   
• FDA Update - Feb 20, 2010: Recent FDA audit reveals FDA’s inspectional policies – Purchasing and Contract Mfrs high on the list
   
• FDA Update – Feb 1, 2010: FDA to Hold Public Meeting on the 510(k) process – Feb. 18.
  RE: Strengthening the Center for Devices and Radiological Health's 510(k) Review Process; Public Meeting
   
• FDA Update - January 25, 2010: FDA Schedules Public Meeting on Premarket Clearance Process for Medical Devices
   
  
• FDA Update – December 30, 2009: Studies on the FDA Approval of PMA’s
   
  
• FDA Update - October 12, 2009: Draft Guidance: Emergency use Authorization (EUA) of Medical Products
   
• FDA Update - October 1, 2009: FDA Will Look To Update 510(k) Database
   
• FDA Update – Sept 23, 2009: FDA Asks Institute Of Medicine To Evaluate 510(k) Review Process
   
• FDA Update – Sept 22, 2009: The FDA releases a Proposed Rule which will Define the Good Manufacturing Practices For Combo Products
   
• FDA update - Sept 17, 2009: RAPS Annual Conference - The New Commissioner's Speech
    
• FDA update - September 3, 2009: FDA Reportable Food Registry
   
• FDA update – August 25, 2009: FDA’s Registration and Listing requirements for FY 2010
   
• FDA update – August 24, 2009: Electronic Medical Device Reporting (eMDR)
   
• FDA Update – August 21, 2009: Electronic Drug Registration and Listing (E-DRLS)
   
• FDA Update – August 12, 2009: New FDA Commissioner – New Edits on dealing with the Industry – But, is New always good for the Industry?
   
• FDA Update – August 10, 2009: Notice of Medical Device User Fee Rates for Fiscal Year 2010
   
• FDA update – July 17, 2009: FDA Move to new Quarters – 510(k) submissions will have some delays.
   
• FDA Update – June 24, 2009: FDA’s new Commissioner to review the agency’s medical device approval process
   
• Update - June 5,2009: FDA wants to be more transparent – what does that mean to the industry?
   
• Update - May 10, 2009: FDA looks to impose more user fees, including food establishment registration fees, increase in medical device submission reviews and a new fee for reinspection of medical device companies that are not in cGMP compliance.
   
• Update - April 20, 2009: FDA Issues Warning letter to Human Testing Firm
   
• Update - April 9, 2009: Checking Safety of Old Devices
   
• Update – February 26, 2009: FDA Takes New Regulatory Action Against Ranbaxy’s Paonta Sahib Plant in India
   
• Update - February 16, 2009: Establishing Overseas Offices
   
• Update – January 25, 2009: Guidance for Industry Submission of Laboratory Packages by Accredited Laboratories
   
• Update – January 23: Guidance Document – Good Importer Practices (for comment)
   
• Update - January 23, 2009: Two Men Sentenced to Death for Their Involvement in the Chinese Contaminated-Milk Scandal - (RJN 1/23/09)
   
  
• Update - January 16, 2009: The FDA has now approved new regulations pertaining to the registration of Institutional Review Boards
   
  

View the past 10 years of FDA Updates
CLICK HERE FOR THE FDA UPDATE ARCHIVES 1999 -2008

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