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

 FDA UPDATE ARCHIVES 1999 -2010 CLICK HERE       

• FDA update February 1, 2012 – CDRH Ombudsman Annual Report- Calendar Year 2011

• FDA update January 18, 2012 – Evaluation of Automatic Class III Designation (De Novo) Decision Summaries

• FDA update January 4, 2012 – Draft Guidance for Medical Device Classification Product Code

• FDA update January 3, 2012 – Food sandwich manufacturing company in the Chicago-area has agreed to stop producing and distributing the ready to eat sandwiches

• FDA update December 28, 2011 – Draft Guidance for the 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] 

• FDA update December 28, 2011 –  Draft Guidance for Industry and Food and Drug Administration Staff CDRH Appeals Processes

• FDA update December 21, 2011 – Guidance for Industry: Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices

• FDA update December 19, 2011 – Draft Guidance for Industry: Evaluation of Sex Differences in Medical Device Clinical Studies

• FDA update December 19, 2011 – FDA cracks down on DIY sperm donor in California

• FDA update December 14, 2011 - Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device Designations

• FDA update December 1, 2011 – FDA approves first generic version of cholesterol-lowering drug Lipitor

• FDA Update November 30, 2011 - FDA takes enforcement action against Pennsylvania dietary supplement maker:
   
• FDA update November 4, 2011 – Venture Capitalists Put Money on Easing Medical Device Rules
   
• FDA update November 1, 2011 – Revision of ISO 13485
   
• FDA update October 12, 2011 – FDA Revises Import alert-Detention without physical examination of medical instruments from Pakistan
   
• FDA update October 11, 2011 – FDA, CMS launch pilot program for voluntary parallel review of innovative devices 
   
• FDA update October 4, 2011 – Report on Regulatory Science in FDA’s Center for Devices and Radiological Health: A Vital Framework for Protecting and Promoting Public Health 
   
• FDA update October 3, 2011 – Documents the Center for Devices and Radiological Health is considering for Development (FY12) 
   
• FDA update October 3, 2011 - Draft Guidance for Industry and Food and Drug Administration Staff: De Novo Classification Process (Evaluation of Automatic Class III Designation
   
• FDA Update September 27, 2011 - Guidance for Industry: FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment
   
• FDA Update September 15, 2011 – FDA announces changes in drug center’s oncology office: Review divisions to be aligned by expertise, disease-specific
  areas
   
• FDA Update September 15, 2011 – FDA Public Meeting on Mobile Medical Apps and Stand-Alone Clinical Decision Support Software 
   
• FDA update September 7, 2011 – Letter to Industry about Import Entry Review Process (September 6, 2011)
   
• FDA Update September 7, 2011 – FDA announces new staff training for medical device reviewers
   
• FDA Update August 30, 2011 – Draft Guidance for Industry Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring:
   
  
• FDA Update August 30, 2011(3) – Draft Guidance for Industry-Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review:
   
• FDA Update August 30, 2011 – Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff Design Considerations for Pivotal Clinical Investigation for Medical Devices:
   
• FDA Update August 30, 2011 – Guidance for Institutional Review Boards and Clinical Investigators: emergency use of test articles:
   
• FDA Update August 17, 2011 - Draft Guidance Post market Surveillance Under Section 522 of the Federal Food, Drug and Cosmetic Act:
   
• FDA Update August 16, 2011 – Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff Design Considerations for Pivotal Clinical Investigation for Medical Devices:
   
• FDA Update August 16, 2011 – Draft Guidance for Industry-Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review 
   
• FDA Update August 15, 2011 -  Medical Devices and the Public's Health, The FDA 510(k) Clearance Process at 35 Years: 
   
• FDA Update August 9, 2011 – Food & Drug Administration drops user fees for medical device companies:
   
• FDA Update August 3, 2011 - FDA update August 3, 2011 – FDA to seek public comment on IOM recommendations:
   
• FDA Update July 29, 2011 - FDA to seek public comment on factors affecting the reprocessing of reusable medical devices:
   
• FDA Update July 27, 2011 - FDA issues “Draft guidance” on device changes that warrant new premarket review:
   
• FDA UDATE July 13, 2011 - Draft Guidance for Industry and Food and Drug Administration Staff In Vitro Companion Diagnostic Devices:
   
• FDA Update July 9, 2011 - Minutes Meeting on MDUFA III Reauthorization:
   
• FDA Update July 8, 2011 - Draft Guidance for Industry and Food and Drug Administration Staff Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices:
   
• FDA Update July 5, 2011 - Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues:
   
• FDA Update July 5, 2011 - Senator tells FDA to Seek Medical Device Industry's Expertise before Changing 510(k) Process:
   
• FDA Update June 24,2011 - Draft Guidance: Applying Human Factors and Usability Engineering to Medical Devices to Optimize Safety and Effectiveness in Design.
   
• FDA Update June 16, 2011 - Initial Results of 510(k) Audit Analysis of Not Substantially Equivalent (NSE) Determinations:
   
• FDA Update June 16, 2011 - Notice to Industry Letters
   
• FDA Update June 10, 2011 - Draft Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology
   
•  FDA Update June 2, 2011 -  Draft Guidance for Industry and Food and Drug Administration Staff Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only
   
• FDA Update May 30, 2011 - FDA is sued over Generic CARBATROL; Lawsuit Challenges FDA Decisions on Pre-MMA 180-Day Exclusivity
   
• FDA Update May 25, 2011 - Study: FDA slows new medical devices
   
• FDA Update May 16, 2011 - Letter to Lumigenix Inc. and Precision Quality DNA Concerning Direct to Consumer Advertising.
   
• FDA Update May 16, 2011 -Territories covered by FDA Regulations
   
• FDA Update - May 9, 2011 - FDA issues new rules under Food Safety Modernization Act
   
• FDA Update - May 5, 2011 -  FDA Might Make Failed Medical Device Information Available to the Public
   
• FDA Update - May 2, 2011 - Evaluation of Automatic Class III Designation (De Novo) Decision Summaries
   
• FDA Update - April 18, 2011 - FDA's PREDICT Application
• FDA Update - May 2, 2011 - Medical Devices in Health Care Settings: Validation Methods and Labeling
   
•  to Launch Nationally 
   
• FDA Update - April 15, 2011 - FDA publishes new guidance on Low Level Laser System for Aesthetic Use
   
• FDA Update - April 15, 2011 - FDA publishes new guidance on 30-Day Notices, 135, PMA Supplements and 75-Day HDE Supplements for Manufacturing Method or Process Changes 
   
• FDA Update - April 6, 2011 - FDA launches consumer-friendly Web search for consumers during recalls
   
• FDA Update - April 5, 2011 - Medical wipes-maker in Hartland, Wisc. stops production
    
• FDA Update - April 4, 2011 - FDA proposes draft menu and vending machine labeling requirements
   
• FDA Update - April 4, 2011 - FDAs “Super Office” of Drug Safety within CDER:
   
• FDA Update - April 1, 2011 - FDA to require ‘substantial equivalence’ for new tobacco products
   
• FDA Update - March 29, 2011 - Pharmaceutical Fraud Pilot Program
   
• FDA Update - March 26, 2011 - Letter to Industry about Import Entry Review Process
   
• FDA Update - March 21, 2011 - FDA Releases Park Doctrine Guidance
   
• FDA Update - March 14, 2011 - FDA issues an Injunction to McNeil-PPC
     
• FDA Update - March 11,2011 - Under pressure, firm shutters line that made tainted wipes
   
• FDA Update - March 10, 2011 - FDA’s new guidance on Class IIb devices
   
• FDA Update - March 9, 2011 - Federal Register: Medical Device Reporting; Malfunction Reporting Frequency
   
• FDA Update - March 9, 2011 - FDA issues new Guidance on Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence:
   
• FDA Update - March 7 2011 -  FDA Intends to Remove Unapproved Drugs from Market
   
• FDA Update - March 5, 2011 - Government Shutdown and the FDA Impact for Companies
   
• FDA Update - MARCH 4, 2011 - New User Fees in 2012
   
• FDA Update - MARCH 2, 2011 - The Biologics Price Competition and Innovation Act of 2009
   
• FDA Update - March 1, 2011 - FDA Proposes Generic Drug User Fee
   
• FDA Update - February 25, 2011- New MDDS Rule
   
• FDA Update – February 23, 2011 - IRB receives warning letter
   
• FDA Update - February 15, 2011 - FDA Publishes Revised Process-Validation Guidance 
   
• FDA Update - February 11, 2011 - FDA launches Medical Device Innovation Initiative
   
•  FDA Update - February 6, 2011 - Federal Government obtains permanent injunction against a company in Texas
   
•  FDA Update - February 4, 2011 - Warning letter to Institutional Review Board (IRB)
   
• FDA Update - February 3, 2011 - Informed Consent Document – New Rule
   
• FDA Update - February 2, 2011 - FDA’s 515 Initiative program  
   
  

View the past 12 years of FDA Updates
CLICK HERE FOR THE FDA Update ARCHIVES 1999 -2010

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