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ContactsListing

Archive of Email Messages


"Dear Member, I thought you might be interested in the following information about MDUFMA. If you have already received this information from other sources, I apologize for this duplication. On October 26, 2002 President Bush signed the Medical Device User Fee and Modernization Act (MDUFMA) of 2002. MDUFMA amends the Federal Food, Drug and Cosmetic (FFD&C) Act to provide FDA important new responsibilities, resources, and challenges. MDUFMA has three particularly significant provisions: -User fees for premarket reviews; -Establishment inspections may be conducted by accredited persons (third-parties); -New regulatory requirements for reprocessed single-use devices. On Friday, November 7, 2002 the Center for Devices and Radiological Health created a new website dedicated to MDUFMA. Included on this website are links to reference materials and background information on MDUFMA, including a full text of the law, summary of the law, and the Legislative History of MDUFMA. In addition there is a Frequently Asked Questions (FAQ) document, which should help you address questions you may have regarding the new law. As we proceed with implementation of MDUFMA, CDRH expects to update the website regularly, so I encourage you to check it often for new developments. You can access the MDUFMA homepage at: www.fda.gov/cdrh/mdufma/index.html. The Division of Small Manufacturers, International and Consumer Assistance (DSMICA) can answer basic questions concerning the new law, and help you find guidance documents and other reference materials. DSMICA's contact information can be found on the Internet at: www.fda.gov/cdrh/devadvice/36f.html If you have a question that is not answered by DSMICA or the available reference materials, send an E-mail message to MDUFMA@cdrh.fda.gov. Sincerely yours, Contacts Listing (CDRH UserID: 18) (Distribution#: 13)"December 16, 2002Medical Device Manufacturer
Dear Member, Here is some information on a future broadcast that you may find useful. U.S. Food and Drug Administration Center for Devices and Radiological Health Center for Biologics Evaluation and Research Presents a live, interactive satellite broadcast and webcast 'MDUFMA Series: Device User Fee Billing Procedures' April 9, 2003 Test: 12:30 PM EST / Program: 1:00 - 2:30 PM EST C-Band, Galaxy 4R, Trans 23, 4160 MHz, Horizontal Polarity, 99 Degrees West With the signing of the 2003 Federal budget, FDA can begin to collect medical device user fees under the recently enacted Medical Device User Fee and Modernization Act. This live video teleconference will provide manufacturers of medical devices and in vitro diagnostic products with up-to-date information on their responsibilities under the Act. A panel of FDA experts will describe the payment process for sponsors of new products, discuss important definitions under the law, and explain how the fees apply to products reviewed by FDA's Center for Biologics Evaluation and Research (CBER) and FDA's Center for Devices and Radiological Health (CDRH). The panel will also discuss the ways a sponsor may qualify for the waivers and reduced fees available to small businesses. Viewers will have the opportunity to question the panelists during the broadcast by phone, fax or e-mail. In the meantime, information on the user fee regulations is available at http://www.fda.gov/oc/mdufma/. Panelists: Linda Kahan, Deputy Director, CDRH/ FDA Frank Claunts, Finance Coordinator, FDA User Fee Programs Diane Maloney, Associate Director for Policy, CBER/FDA Bob Yetter, Associate Director for Review Management, CBER/FDA Joanne Less, Project Manager, MDUFMA Steering Committee/FDA James Norman, Assistant to the Director, OSM/CDRH/FDA Mark Barnett, Asst. Director for Education and Communications, CDRH/FDA (moderator) Who Should Watch? Manufacturers of medical devices and diagnostic products who may be affected by the new medical device user fee regulations should watch this broadcast or webcast. Viewing the Program: Interested viewers will need to find a site with a steerable dish capable of receiving a C-Band satellite signal. Additional technical information is available at www.fda.gov/cdrh/ohip/dcm. Webcast: A live webcast and 12-month archive of the program will be available at http://www.fda.gov/oc/mdufma/. How to Submit a Question: During the broadcast viewers will be able to ask their questions by phone, fax or e-mail. The fax and phone numbers will be announced at the beginning of the broadcast. E-mail questions can be sent at any time before the broadcast, and during the broadcast, to: tvquestion@cdrh.fda.gov Sincerely yours, Contacts Listing (CDRH UserID: 18) (Distribution#: 14) March 4, 2003Medical Device Manufacturer
Dear Member, Information on the Reuse of Single-Use Devices (SUDs): Important information regarding the supplemental validation data submissions for reprocessed SUDs is now available on the Center for Devices and Radiological Health’s Reuse of Single-Use Devices webpage at http://www.fda.gov/cdrh/reuse/svs/index.html . New information includes: - FAQs on the Status of Reprocessed Single-Use Devices (SUDs) that receive a Not Substantially Equivalent (NSE) Letter; and - Listing of reprocessed SUDs for which FDA review has been completed or terminated. FDA will update the lists as additional information on these submissions becomes available. We urge you to check these lists periodically if you wish to verify the status of reprocessed devices that you are purchasing. Sincerely yours, ContactsListing Center for Devices and Radiological Health Food and Drug Administration Department of Health and Human ServicesNovember 15, 2004Reuse of Single Use Devices Policy
Dear Member, The Food and Drug Administration (FDA) is proud to introduce Heart Health Online (http://www.fda.gov/hearthealth) a new website devoted to cardiovascular health. Heart Health Online provides valuable FDA health information that you will be interested in learning. The site includes descriptions of cardiovascular conditions, links to detailed information about specific diagnostic tests, medications, medical devices, and healthy lifestyles. Sincerely yours, Contacts Listing (CDRH UserID: 18) (Distribution#: 12)June 17, 2004Cardiovascular
Dear Member, FDA is sending you a copy of a press release about syringes preloaded with heparin or sodium chloride used to flush intravenous catheter lines possibly contaminated with pseudomonas fluorescens. We would like you to help us spread the word that these pre-loaded syringes manufactured by IV Flush, LLC and distributed by Pinnacle Medical Supply should not be used. Please forward this electronic message, attached below, to your constituents as soon as possible. Thank you. Press Release: http://www.fda.gov/bbs/topics/news/2005/NEW01154.html Sincerely yours, ContactsListing Center for Devices and Radiological Health Food and Drug Administration Department of Health and Human ServicesFebruary 8, 2005Cardiovascular
Dear Member, Do you know of barriers that prevent medical devices being available to treat or diagnose diseases and conditions that affect children? If so, please help FDA report to Congress on this issue by August 20, 2004. We are eager for your help in answering the specific questions in the Federal Register notice below. Note that you need to send your comments to Docket No. 2004N-0254. In your answers, please --identify unmet pediatric device needs, --discuss the barriers to meeting those needs, and --propose ways to make devices appropriate for pediatric patients more available. Don’t send your comments directly to ContactsListing. You can see the notice also at: http://www.fda.gov/OHRMS/DOCKETS/98fr/04-13872.htm. A printable PDF version is available at: http://www.fda.gov/OHRMS/DOCKETS/98fr/04-13872.pdf Thank you for your help. Sincerely yours, Contacts Listing (CDRH UserID: 18)July 1, 2004Pediatrics
Dear Member, In CDRH’s Contact Listing database, you expressed an interest in the topic Xray Diagnosis and/or Cancer. Some medical imaging facilities are promoting a new use of computed tomography (CT). They are promoting it for healthy individuals who have no symptoms or suspicion of disease as a preventive or proactive health-care measure. You should know that scientists have not shown that whole-body CT screening is effective. On April 26, 2002, CDRH posted a new website on “Whole-Body Scanning Using Computed Tomography (CT)” ( http://www.fda.gov/cdrh/ct ). It includes: • information on the use of whole-body CT screening; • an explanation of what CT is and how it works; • information on radiation risk; • a brief description on radiation quantities used to indicate patient dose; • a brief explanation on the regulatory status of CT; and • a resource list and links to other CT related sites. Sincerely yours, Contacts Listing (CDRH UserID: 18) (Distribution#: 21)May 21, 2002Xray Diagnosis
Dear Member, Thank you for your interest in the FDA's Public Meeting on Medical Devices in the Home Healthcare Community. FDA has posted an announcement of the meeting on its Website at http://www.fda.gov/cdrh/meetings/meddevhome.html The agenda for the meeting is at http://www.fda.gov/cdrh/meetings/meddevhome-agenda.html If you would like to make a brief statement at the meeting, please register by Email at cdrhhhc@cdrh.fda.gov Do not follow the registration directions in the FederalRegister announcement--they are incorrect. Thank you. Sincerely yours, Contacts Listing (CDRH UserID: 18) (Distribution#: 11)"September 4, 2002Home Health Care
Dear Member, Below is a message from the Home Health Care Committee (http://www.fda.gov/cdrh/cdrhhhc/): This summer, the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) Home Health Care Committee (HHCC) announced a new program to collaborate with infusion pump manufacturers to ensure the safe and effective use of infusion pumps in the home environment. The FDA introduced the program in August through an online announcement that explained the program’s vast benefits to patients, home health care providers, and infusion pump manufacturers. At the outset of the program, the FDA requested that infusion pump manufacturers voluntarily submit instructions for use and basic pump information to the HHCC for all infusion pumps marketed during or after 1984. Infusion pump manufacturers are currently in the process of submitting pump information to the HHCC. Once collected, the infusion pump information and instructions for use will become part of CDRH’s publicly accessible home health care device website. This website will increase the likelihood that users—home health nurses, patients, and patients’ families—will have continuous access to pump information and instructions for use to help ensure the safe and effective use of infusion pumps in the home. To read more about the program’s benefits and submission process, please visit the online program announcement at http://www.fda.gov/cdrh/CDRHHHC/ipumps.html. Sincerely yours, ContactsListing Center for Devices and Radiological Health Food and Drug Administration Department of Health and Human Services November 5, 2004Home Health Care
Dear Member, The Winter 2004 issue of FDA & YOU is now available at www.fda.gov/cdrh/fdaandyou. Topics in this issue include: • flu viruses and vaccines, • over-prescription of antibiotics, • breast implants, • misuse of prescription pain relievers, and • trans fats and nutrition tips. FDA & YOU events: Visit FDA & YOU at the National Association of Secondary School Principals (NASSP) Convention in Orlando, Florida February 27th-March 1st, Booth 1237. Share your ideas, comments and concerns regarding our publication with the FDA & YOU staff. Sincerely yours, Contacts Listing (CDRH UserID: 18) (Distribution#: 21)January 29, 2004"FDA & You" Newsletter
Dear Member, The Spring/Summer 2004 issue of FDA & YOU is now available at www.fda.gov/cdrh/fdaandyou. Articles in this issue include: • FDA Bans Ephedra, • Weighing in On Obesity, • Sun Safety: Protect the Skin You’re In, • Decoding Sunscreen Labels, • Sun Safety Tips, • Do a Skin Cancer Check, • Focus On: Henna, • The Lowdown: Buying Medical Products Online, • The Safe Use of Over-The-Counter Drugs, • Calendar of National Health Events, and • New Department of Health and Human Services (DHHS) organ donation website for teens. FDA & YOU events: We’re in the process of redesigning the FDA & YOU website to better meet your internet teaching and learning needs. Let us know what you’d like to see on the new FDA & YOU website by sending an email to mailto:fdaandyou@fda.cdrh.gov. Sincerely yours, Contacts Listing (CDRH UserID: 18) (Distribution#: 11)May 28, 2004"FDA & You" Newsletter
Dear Member, Are you planning to attend the National Association of School Nurses (NASN) in Seattle, Washington (July 11th-14th)? Come by and visit the FDA booth - number 426C. Talk with the FDAers there and share your ideas, comments and concerns on FDA & YOU (http://www.fda.gov/cdrh/fdaandyou/), our newsletter for secondary school health educators and students. Sincerely yours, Contacts Listing (CDRH UserID: 18) (Distribution#: 20)"July 8, 2004"FDA & You" Newsletter
Dear Member, The Fall 2004 issue of FDA & YOU is now available at www.fda.gov/cdrh/fdaandyou. Articles in this issue include: --Teens and Breast Implants, --FDA Makes a Change to Tampon Labeling, --The Trouble with Tiny Turtles: A Look at Reptile-Related Salmonella, --Tips for Preventing Salmonella Poisoning, --Cleaning up the Flood: Important Food Safety, --Food Safety Quiz, --Add Hepatitis B Vaccination to Your Back to School List, --All About Vaccines, --Counterfeit Medicines: Filled with Empty Promises, and --a Calendar of National Health Events. FDA & YOU events: The FDA & YOU website has been re-designed. New features include an improved navigation and graphic design, with additional features to appear in the coming months. Sincerely yours, ContactsListing Center for Devices and Radiological Health Food and Drug Administration Department of Health and Human Services (Distribution#: 29)October 21, 2004"FDA & You" Newsletter
Dear Member, Introducing 'Ask the Eagle' FDA & YOU news for health educators and students is pleased to announce 'Ask the Eagle'. 'Ask the Eagle' is a new feature in the newsletter that gives you the opportunity to ask FDA experts any question related to the Agency's activities or regulated products. All questions will be answered - but the best will be chosen for publication in future issues of the newsletter. Don’t miss this opportunity to involve your school. Submit your questions via the web at http://www.fda.gov/cdrh/fdaandyou/eagle.html today! Sincerely yours, ContactsListing Center for Devices and Radiological Health Food and Drug Administration Department of Health and Human ServicesNovember 29, 2004"FDA & You" Newsletter
Dear Member, The Winter 2005 issue of FDA & YOU is now available at www.fda.gov/cdrh/fdaandyou. Articles in this issue include: * Got Milk? Make Sure It’s Pasteurized * Laser Pointers: Use With Care * Learn About it Online: LASIK Eye Surgery * The Over-the-Counter Drug Facts Label—Take a Look! * Protect Yourself Against Tampering * Stopping Germs at Home, Work and School * Cold or Flu? * Asthma Basics * Science and Our Food Supply: Serving Up Lessons in Food Safety * New Dietary Guidelines Will Help Americans Make Better Food Choices, Live Healthier Lives * Science in the News: New Study on Teens and Fast-food * Puzzles * Calendar of National Health Events Sincerely yours, ContactsListing Center for Devices and Radiological Health Food and Drug Administration Department of Health and Human Services February 7, 2005"FDA & You" Newsletter
Dear Member, On September 2, 2004, FDA posted a new Class I Recall at http://www.fda.gov/cdrh/recalls/. Product: Medibo Minerva Patient Lifts Date Recall Began: August 4, 2004 Sincerely yours, Contacts Listing (CDRH UserID: 18) (Distribution#: 24)September 7, 2004Class I Recalls
Dear Member, On September 15, 2004, FDA posted a new Class I Recall at http://www.fda.gov/cdrh/recalls/. Product: Nellcor CapnoProbe Sublingual Sensors, Models SLS-1 and SLS1-S Date Recall Began: August 24, 2004 Sincerely yours, ContactsListing Center for Devices and Radiological Health Food and Drug Administration Department of Health and Human Services (Distribution#: 26)September 17, 2004Class I Recalls
Dear Member, On September 30,2004, FDA posted a new Class I Recall at http://www.fda.gov/cdrh/recalls/. Product: Pulmonetic Systems LTV series of ventilators, models 1000, 950, 900 and 800. Approximately 10,300 devices are in domestic and international distribution. Date Recall Began: September 8, 2004 Sincerely yours, ContactsListing Center for Devices and Radiological Health Food and Drug Administration Department of Health and Human Services (Distribution#: 31)September 30, 2004Class I Recalls
Dear Member, On November 19, 2004, FDA posted a new Class I Recall at http://www.fda.gov/cdrh/recalls/. Product: Access CardioSystems, Inc. Automated External Defibrillators (AEDs), serial numbers 075690 to 077140 or 075180 to 084760. Approximately 10,000 devices are in distribution. Date Recall Began: November 3, 2004 Sincerely yours, ContactsListing Center for Devices and Radiological Health Food and Drug Administration Department of Health and Human ServicesNovember 29, 2004Class I Recalls
Dear Member, On December 03,2004, FDA posted a new Class I Recall at http://www.fda.gov/cdrh/recalls/. Product: Tosoh Bioscience AIA-600 II Enzyme Immunoassay Analyzer, software version 3.02. Date Recall Began: April 2, 2003; however, FDA first learned of this problem during an inspection of the firm during August - September 2004. Sincerely yours, ContactsListing Center for Devices and Radiological Health Food and Drug Administration Department of Health and Human Services December 3, 2004Class I Recalls
Dear Member, On December 9, 2004, FDA posted a new Class I Recall at http://www.fda.gov/cdrh/recalls/. Product: Pulmonetic Systems Universal Cable Adaptor for use on LTV Series Ventilator. Approximately 1129 adaptors have been distributed. Date Recall Began: November 19, 2004 Sincerely yours, ContactsListing Center for Devices and Radiological Health Food and Drug Administration Department of Health and Human ServicesDecember 13, 2004Class I Recalls
Dear Member, On January 3, 2005, FDA posted a new Class I Recall at http://www.fda.gov/cdrh/recalls/. Product: Unomedical Hospitak brand 22 mm/15 mm airway adapter. The potentially affected lots are 04-40, dated 2004 09 and 04-41, dated 2004 10. Date Recall Began: December 2, 2004 Sincerely yours, ContactsListing Center for Devices and Radiological Health Food and Drug Administration Department of Health and Human ServicesJanuary 4, 2005Class I Recalls
Dear Member, On January 31 ,2005, FDA posted a new Class I Recall at http://www.fda.gov/cdrh/recalls/. Product: Becton Dickinson Diagnostic Systems ProbeTec ET Urine Processing Kit Date Recall Began: January 10, 2005 Sincerely yours, ContactsListing Center for Devices and Radiological Health Food and Drug Administration Department of Health and Human Services February 1, 2005Class I Recalls

Updated on January 18, 2006 at 06:35:05
(ContactsListing v1.7)

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