FDA Update Archives FDA Update Archives: 2009 — 2012 2012 FDA Update December 31st 2012 - Recent Development on PMA and 510K submissions!!!! FDA Update December 30, 2012 - Taxable Medical Devices!!!!! FDA Update December 20, 2012 - Comprehensive Assessment of the Process for the Review of Device Submissions FDA Update December 17, 2012 - Design Considerations for Devices Intended for Home Use; Availability!!! FDA Update December 11, 2012 Agency Information Collection Activities!!! FDA Update December 10, 2012 -EU Court Ruling about Definition on Medical Device FDA Update December 5, 2012 - FDA Update for CDRH Strategic Priorities FDA Update December 5, 2012 - Extension of Device Establishment Annual Registration Deadline FDA Update December 5, 2012 - Update on the DGMPAC FDA UPDATE – December 3, 2012 - THE TOP TEN – 483 Citations for 2012 FDA Update December 2, 2012 Electronic Source Data in Clinical Investigations FDA Update December 2, 2012 - New Draft Guidance for IRBs, Clinical Investigators, and Sponsors IRB Responsibilities!!! FDA Update November 30, 2012 - CDRH Export Certification and Tracking System (CECATS) FDA update November 30, 2012 - Important Notice about Medical Device Registration and Listings FDA Update November 26, 2012 - CDRH Fiscal Year 2013 (FY 2013) Proposed Guidance Development FDA Update November 20, 2012 - Amendments to the UDI Rule!!!< FDA Update November 20, 2012 - Medical Devices; Custom Devices; Request for Comments FDA update November 19, 2012 - Drug Establishment Registration/Drug Listing UPDATE FDA update November 16, 2012 - Device Registration and Listing FDA Update October 17, 2012 - New Advancement- The E-Copy Program! FDA update October 15, 2012 - Release of a New Guidance on effects of FDA and Industry actions on the FDA review clock and goals FDA Update October 2, 2012 - Great Development From the FDA FDA Update Octfober 1, 2012 - Important Notice concerning re-registration period for domestic and foreign drug manufacturers FDA UPDATE September 14, 2012 - New FDA Registration Requirements for Medical Device Companies FDA Update September 12, 2012 - FAQ’s on New Device Registration and Listing Requirements FDA update September 7, 2012 - Strengthening our national System for medical device Post market Surveillance FDA update August 24, 2012 - Important changes to US FDA establishment registration requirements FDA update August 23, 2012 -Medical Device Classification Product Codes FDA update August 17, 2012 - Unique Device Identifier Rule (UDI) FDA update August 13, 2012 - Refuse to Accept Policy for 510(k)s FDA Update August 3, 2012 - Medical Device Establishment Registration and Listing – Notice of Changes for FY 2013 FDA Update August 3, 2012 - Biosimilar User Fee Rates for Fiscal Year 2013 FDA Update August 3, 2012 - Prescription Drug User Fee Rates for Fiscal Year 2013 FDA update August 1, 2012 - Medical Device User Fee Rates for Fiscal Year 2013 #2 FDA update August 1, 2012 - Medical Device User Fee Rates for Fiscal Year 2013 FDA Update July 31, 2012 - Caustic Crusader at the Centre of FDA Scandal FDA Update July 30, 2012 - Acceptance and Filing Review for Pre-Market Approval Applications (PMA’s FDA Update 18th July, 2012 - The Food and Drug Administration (FDA) has published the draft guidance entitled ``Medical Devices: The Pre- Submission Program and Meetings with FDA Staff. FDA update 5th July 2012 - Guidance for Industry and FDA Staff: Clinical Performance Assessment FDA update 3rd July 2012 – FDA proposes unique device identification system for medical devices FDA update June 18, 2012 – FDA 483 Strategies – Understanding what the FDA-483 represents and what it can mean – for the foreign company FDA Update June 12, 2012 - SPECIAL UPDATE - FDA woes drag on for HME manufacturers FDA Update June 8, 2012 - Update on Bacteria Found in Other- Sonic Generic Ultrasound Transmission Gel that poses risk of infection FDA Update 06/08/2012 - FDA Charges for REINSPECTION FDA update June 7 , 2012 – FDA’s new policy for 483 Responses – Be aware what is needed to prevent a Warning Letter FDA Update June 4, 2012 - INDUSTRY UPDATE: Nylon12 & Pebax FDA update May 30, 2012 – Guidance for Small Business Qualification and Certification FY 2012 FDA upsate May 30. 2012 - Draft Guidance: Applying Human Factors and Usability Engineering to Medical Devices to Optimize Safety and Effectiveness in Design. FDA update May 7, 2012 - Apotex Sues FDA over “Import Alert” FDA update May 1, 2012 – Interactive Map of Fiscal Year 2011 FDA cGMP Warning Letters FDA update April 10, 2012 – Guidance for Industry and Food and Drug Administration Staff FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act FDA update March 28, 2012 – Factors to consider when making Benefit – Risk determinations in Medical Device Premarket Approval and De Novo Decisions FDA Update March 20, 2012 – Minutes from Stakeholder Meeting on MDUFA III Reauthorization, February 28, 2012 FDA Update March 20, 2012 - Guidance on 13485:2003 Voluntary Audit Report Submission Pilot Program 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 2011 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 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