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     FDA UPDATE ARCHIVES   1999 through 2010

  ARCHIVES: 

2010

• FDA UPDATE - December 9, 2010 - UDI – Unique Device Identification - Request for Use Case
• FDA UPDATE – December 2, 2010 – 510(k) process should not be hindered
• FDA update – November 7, 2010: DeNovo Application has finally come to realization
  
• FDA Update – Sept 23, 2010: FDA Warning Letter Close-Out Letter
• FDA Update – Sept 15, 2010: Another medical device association declares that the FDA clearance process for devices, contrast agents is ‘broken’ – Surprise, Surprise
• FDA Update – Sept 14, 2010: New guidance documents for Glasses and Spectacles
• 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

2009

• 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• FDA Update - October 12, 2009: Draft Guidance: Emergency use Authorization (EUA) of Medical Products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

2008

• Update - November 26, 2008:FDA changes the AQL for the examination of Gloves
• Upda te – August 19, 2008: All medical device Companies need to be aware of these changes from the FDA concerning the new user fees.
• Update - August 15, 2008: Congressman John Dingell back in Charge
• Update – August 4, 2008: User fees for FY 2009 will go up
• Update – July 19, 2008: FDA to Establish Offices in India by 2009
• Update – June 25, 2008: Change in FDA nomenclature
• Update – June 16, 2008: Medical Device Reporting: Baseline Reports are no longer required
• Update - May 27, 2008: Medical Device Tracking
• Update – April 2, 2008: FDA Seeks Civil Penalties from Calif. Device Maker
• Update February 21, 2008: Victory For Device Industry
• Update – February 1, 2008: CLIA Guidance Document

2007

• Update December 28, 2007: New Guidance by FDA: Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements
• Update December 20, 2007: eMDR – electronic Medical Device Reporting
• Update December 3, 2007: On September 27, 2007, President Bush signed the Food and Drug Administration Amendment Act of 2007 or FDAAA.
• Update Oct 3, 2007: Requirements for Contract Manufacturers and Contract Sterilizers – Registration and Listing and the new User Fees
• Update October 1, 2007: FDA gives with one hand and takes with the other - New FDA user fees imposed
• Update June 7, 2007: Guidance for Assayed and Unassayed Quality Control Materials
• Update April 23, 2007: FDA Announces Recommendations to Reauthorize Medical Device User Fee Program
• Update April 17, 2007:FDA Seizes All Medical Products From N.J. Device Manufacturer for Significant Manufacturing Violations
• Update March 26, 2007: U.S. AND JAPAN IMPLEMENT A PROGRAM TO SPEED MEDICAL DEVICE APPROVALS
• Update March 13, 2007: New FDA Guidance “Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests”
• Update February 8, 2007: Custom Ultrasonics Signs Consent Decree with FDA
• Update – Feb. 7, 2007: Role of Standards in the Assessment of Medical Devices
• Update February 3, 2007Wireless Technology in Medical Devices and the New FDA Guidance

2006

• Update December 12th 2006: FDA class 1 recall of Counterfeit One Touch blood glucose strips
• Update October 23rd: FDA Updates its Nationwide Alert on Counterfeit Blood Glucose Test Strips
• Update October 19th: FTC and FDA Act against Internet Vendors of Fraudulent Diabetes Cures and Treatments
• Update October 13th: FDA Issues Nationwide Alert on Counterfeit One Touch Basic/Profile and One Touch Ultra Blood Glucose Test Strips
• Update August 8th: Small Business Qualification, Worksheet and Certification FY 2007
• Update August 3rd: Increase Medical Device User Fee Rates for Fiscal Year 2007
• Update June 30th: Public Meeting for the Use of Bayesian Statistics in Medical Device Clinical Trials
• Update June 29th: Baxter Healthcare Corp. Signs Consent Decree with FDA
• Update June 2: ERG Final Report: Unique Identification for Medical Devices
• Update June 1: Mammography Facility Adverse Event and Action Report – 2005
• Update May 23rd: Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials - Draft Guidance for Industry and FDA Staff
• Update May 22nd: FDA Announces Initiative to Facilitate the Development and Availability of Medical Devices
• Update May 5th: Respironics Issues Worldwide Recall of PLV® Continuum™ Ventilator
• Update April 28th: Public Health Notification - Baxter Healthcare Corporation COLLEAGUE Volumetric Infusion Pumps
• Update April 13th: Boca Medical Products, Inc. Issues Nationwide Recall of Insulin Syringe Product
• Update April 12th: Blackstone Medical, Inc. Issues Voluntary Recall of ICON™ Modular Fixation System
• Update April 3rd: Disetronic Medical Systems, Inc. Announces a Voluntary Nationwide Recall of all ACCU-CHEK™ Ultraflex Infusion Sets
• Update March 29th: March 29th: Ossur Announces Voluntary Recall of Certain Models of the Total Knee®
• Update March 17th: Sepsis and Medical Abortion Update
• Update March 7th: Drug Safety Information: Macugen (pegaptanib sodium injection)
• Update March 2nd: Human tissue recovered by Biomedical Tissue Services, Ltd. (BTS)
• Update February 24: Hanford Pharmaceuticals Issues a Nationwide Recall of Cefazolin for Injection Because of Possible Health Risk
• Update February 22: FDA Informs Public of Nationwide Infant Formula Recall
• Update February 13: FDA-Requested Recall - Cytosol Laboratories, Inc. Product Contains Dangerous Levels of Endotoxin
• Update February 9, 2006 - Reclassification of Hepatitis A Virus Serological Assays and Availability of Class II Special Controls Guidance for Hepatitis A Virus Serological Assays
• Update February 9, 2006 - Reclassification of Intervertebral Body Fusion Device and Availability of Draft Class II Special Controls Guidance Document for the device
• Update February 9, 2006 - FDA Warns Consumers to Stop Using Recalled Liquid-Filled Children’s Teething Rings Manufactured by RC2 Brands (The First Years)
• Update February 8, 2006 - Advice for Patients with Cochlear Implants: New Information on Meningitis Risk
• FDA Update - January 22, 2006 - New Product Codes for Radiation-Emitting Electronic Products
• FDA Update - January 18, 2006 - Roche Diagnostics Issues a Worldwide Voluntary Recall of Some of its ACCU-CHEK® Aviva Meters
• FDA Update - January 17, 2006 - FDA Issues Guidance “Exemption from Reporting and Recordkeeping Requirements for Low Power Laser Products”
• FDA Update - January 9, 2006 - Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays

2005

• FDA Update - December 20, 2005 - Endologix Announces Limited Voluntary Recall of Powerlink System Delivery Catheter
• FDA Update - December 19 2005 - Class 1 Recall: Baxter Healthcare Corp. Meridian® Hemodialyis (HD) Instrument
• FDA Update - December 9, 2005 - Draft Guidance for Industry and FDA - Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens
• FDA Update - December 6, 2005 - Boston Scientific Announces Worldwide Recall of Stainless Steel Greenfield® Vena Cava Filters Manufactured Before March 10, 2004
• FDA Update - December 5, 2005 - FDA Approves First Test to Screen for West Nile Virus
• FDA Update - November 15, 2005 - Draft Guidance - Special Control for Latex Condoms with and without Spermicidal Lubricant
• FDA Update - November 11, 2005 - Guidance for Industry and Staff – Pilot Program to Evaluate Proposed Globally Harmonized Alternative for Premarket Procedures
• FDA Update - November 8, 2005 - Classification of Low Energy Ultrasound Wound Cleaner and Issuance of Related Guidance
• FDA Update - November 8, 2005 - Issuance of Draft Guidance for Tinnitus Marker Devices
• FDA Update - October 19, 2005 - FDA Issues Device Cost Analysis Report entitled, “FY 2003 and FY 2004 Unit Costs for the Process of Medical Device Review”
• FDA Update - October 18, 2005 - United States Marshals Seize Violative Infusion Pumps Made by Baxter Healthcare Corporation
• FDA Update - October 7, 2005 - Plan B-Victim to a Politicized FDA - We Hope Not!
• FDA Update - Sept 19, 2005 - FDA Guidance on Inspection of Manufacturing Facilities by Accredited Third Parties
• FDA Update - August 31, 2005 - FDA Offers Tips about Medical Devices and Hurricane Disasters
• FDA Update - August 12, 2005 -  Medical Device User Fee Rates for 2006
• FDA Update - August 1, 2005 - Delay in publication of Medical Device User Fees for Fiscal Year 2006

2003 - 2004

• FDA Update - August 2, 2004 - FDA new user fees for 2005
• FDA Update – March 27, 2004 - Advancing America’s Health. Advancing Medical Breakthroughs
• FDA Update - November 25, 2003 - Guidance for Industry and FDA Staff: Bundling Multiple Devices or Multiple Indications in a Single Submission
• FDA Update – November 15, 2003 - Recalls and the FDA
• FDA Update - November 3, 2003 - INTERNATIONAL NEWS UPDATE
• FDA Update – October 13, 2003 - Manufacturer and User Facility Device Experience Database - (MAUDE)
• FDA Update – September 11, 2003 - User Fee raise is only a few weeks away! 
• FDA Update – August 8, 2003 - Medical Device Reprocessor Signs Consent Decree
• FDA Update – August 7, 2003 - FDA Announces New Goal for Reducing Total Device Review Times
• FDA Update - August 1, 2003 - FDA announces new User Fee increases for 2004
• FDA Update - July 22, 2003 - Premarket Assessment of Pediatric Medical Devices
• FDA Update – July 7, 2003 - A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Pre-market Procedures
• FDA Update - July 02, 2003 - The FDA Pursues an Aggressive Enforcement Strategy - to protect the public health
• FDA Update – June 26, 2003 - Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002
• FDA Update – June 24, 2003 - NEW FDA PILOT PROGRAM – Posting Firm’s Responses to Warning Letters
• FDA Update - June 17, 2003 - Guidant Corp. agrees to pay fines of $92.4 million after pleading guilty
• FDA Update – June 4, 2003 - FDA USER FEES will not stay at these levels for long.
• FDA Update 5/30/2003 - FDA issues a new 510(k) guidance document - resorbable calcium salt bone void filler device.
• FDA Update 5/29/2003 - FDA Seeks Injunction Against Multidata Systems Intl.
• FDA Update 5/22/2003 - OMBUDSMAN'S ANNUAL REPORT
• FDA Update 4/3/2003 - Medical Devices; Patient Examination and Surgeons' Gloves; Test
  Procedures and Acceptance Criteria
• FDA Update 3/6/2003 - FDA COMPLETES FIRST STEPS OF ITS BROAD INITIATIVE TO IMPROVE REGULATION OF PHARMACEUTICAL MANUFACTURING
• FDA Update 2/26/2003 - Part 11 – The FDA issues a new Compliance Guidance Document
• FDA Update 2/25/2003 - The FDA announces the User Fee Procedures on how to make payment.
• FDA Update 2/24/2003 - Guidance for Industry and FDA:
  FY 2003 MDUFMA Small Business Qualification Worksheet and Certification
• FDA Update 2/14/2003 #2 - FDA Increases Export Certificates Fees
• FDA Update 2/14/2003 #1 - FDA Terminates the Medical Device Warning Letter Pilot Program
• FDA Update 2/4/2003 #1 - The FDA announced the Fiscal 2004 budget.
• FDA Update 2/4/2003 #2 - FDA announces the following:
  FDA LAUNCHES INITIATIVE TO IMPROVE THE DEVELOPMENT AND AVAILABILITY OF INNOVATIVE MEDICAL PRODUCTS
• FDA Update 1/23/2003 - 2003 Clinical Trial Guidance – Patient Population Selection
• FDA Update 1/13/2003 - Correction User Fees
• FDA Update 1/3/2003 - Determination of Intended Use for 510(k) Devices; Guidance for CDRH Staff
• FDA Update 1/3/2003 - Reprocessed Single-Use Devices – New regulations

2002

• FDA Update 12/1/2002 - Performance Goals For The Medical Device User Fee And Modernization Act Of 2002
• FDA Update 11/14/02 - Needlesticks
• FDA Update 11/6/02 - Medical Device User Fee and Modernization Act of 2002
• FDA Update 11/5/02 - FDA changes Recall Reporting
• FDA Update 10/22/02 -FDA approves Device User Fees and 3rd Party Audits
• FDA Update 9/6/02 - CDRH to Establish New Office to Regulate IVDD
• FDA Update 9/5/02 - Electronic Records
• FDA Update 9/2/02 - Orphan Products
• FDA Update 8/20/02 - User Fees
• FDA Update 8/15/02 - Export Certificates
• FDA Update 8/7/02 - Whole Body Screening – CT Screening
• FDA Update 7/3/02 - FDA says nicotine water is an illegal drug, can’t be sold.
• FDA Update 7/3/02 - Public Meeting on BAR CODE LABELING FOR MEDICAL PRODUCTS
• FDA Update 7/1/02 - FDA secrets tempt insiders to lie, cheat, steal
• FDA Update 6/20/02 - FDA SUSPENDS OPERATIONS OF MEDICAL GAS FACILITY
• FDA Update 6/5/02 - FDA Steps Up Surveillance of Medical Devices
• FDA Update 5/20/02 - The FDA is looking for your input
• FDA Update 5/18/02 - SCHERING PLOUGH SIGNS CONSENT DECREE WITH FDA AGREES TO PAY $500 MILLION
• FDA Update 5/13/02 - Watson Laboratories, Inc. Signs Consent Decree with FDA Requiring Corrective Actions be taken at Firm's Corona, California Manufacturing Plant
• FDA Update 2/6/02 - FDA's Budget Proposal for FY 2003
• FDA Update 1/7/02 - FDA issues Final Rule: Exports: Notification and Recordkeeping Requirements
• FDA Update 1/3/02 - FDA Inspection Keeps Abbott Laboratories' Plant Closed 12/27/2001

2001

• FDA Update 11/29/01 - President Bush Signs Record FY 2002 Budget
• FDA Update 11/27/01 - FDA Requires Designated Agent for ALL Foreign Manufacturers
• FDA Update 11/16/01 - Special Controls Guidance Documents to Reduce Regulatory Burden
• FDA Update 10/8/01 - FDA comes out with Strategic Plan "Taking Us into the Future"
• FDA Update 10/3/01 - FDA issues a Guidance for Industry Records: Electronic Signature Validation 
• FDA Update 10/01/01 - Medical Device Reporting Guidance Document; Remedial Action Exemption
• FDA Update - Recall of Zirconia Ceramic Femoral Heads for Hip Implants
• FDA Update - Former medial Company Official Sentenced to 10 Months: Charged with Fraud Against the United States. 
• FDA Update - Recognition and Use of Consensus Standards; Final Guidance for Industry and FDA Staff
• FDA Update - Evaluating Breakthrough Technology: An FDA Perspective
• FDA releases results of the Medical Device Manufacture's Survey Evaluation on FDA Quality System/GMP Inspections
• FDA requests Hospitals to Volunteer for FDA Site Visits
• FDA Update - Guidance on Medical Device Patient Labeling
• FDA Update - FDA Provides Guidance For Industry - Acceptance of Foreign Clinical Studies
• FDA Update - FDA Releases their updated Compliance Program - CP7382.845
• FDA Update – FDA Holds a Webcast on Human Factors
• FDA Update - HACCP - A Study for Medical Device Manufacturing
• FDA Update - FDA Finalizes the Regulations
   for the Reuse of SUDs (Single Use Disposal Devices)
• FDA Update - Scheme to Sell Gas Grill Igniters For Pain Relief Backfires

2000

• FDA Update - Suggested Format for Developing and Responding to the FDA concerning deficiencies in the 510(k) and PMA's
• FDA Update - Teleconference "Integrating Human Factors Engineering into Medical Device Design, Development and FDA Oversight" -- October 11, 2000 
• FDA Update - Over-the-counter In Vitro Diagnostic Devices
• FDA Update - Pediatric Oncology Studies
• FDA Update - Content and Format of the Adverse Reactions Section 
• FDA Update - Allergic Rhinitis: Clinical Development 
• FDA Update - liquid chemical sterilants/high level disinfectants 
• FDA Update - Drug Recalls raise fears about the approval process
• FDA Update - Mar'00 1999 Law Enforcement

1999

• FDA Update - Jan '00 Y2K Readiness
• FDA Update - Reprocessing operations
•  *SPECIAL NOTICE*   FDA Update NEW CONTACT  NUMBERS
• FDA Update July 1999 Enforcement Policy: Electronic records; Electronic signatures
• FDA Update July 1999 Civil Money Penalty
• FDA Update May 1999 Foreign Establishments
• FDA Update April 1999 Seafood HACCP Transition Guidance
• FDA Update April 1999 Exports
• FDA Update March 1999 Design Control
• FDA Update March 1999 Yr 2000 Budget
• FDA Update February 1999

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