Sound Advice

A number of peer review, clinical trials, a report on the putting into service and use of positive displacement, as well as health-care establishments needleless connectors to the reduction of infection after changing to another type of bloodstream infections needleless connector.However, the amount of the bloodstream infection risk compared to other needleless devices, these connectors, or whether the risk of some or all of the information relating to the positive displacement is probably the connectors were incomplete. FDA is ordering product safety to better understand the use of bloodstream infections, the risk of positive displacement connectors needleless.

Device:

Positive displacement needleless connector is part of the system, with regard to the use of intravascular needleless. these devices can also be referred to as the "activated luer valves," "connectors," or "run" and may refer to the "positive pressure" or "positive displacement", their descriptions.

Healthcare Professionals recommendations:

In 2008, the two professional associations adopted guidelines for the small hospital acquired infections (http://www.journals.uchicago.edu/toc/iche/2008/29/s1). For the purpose of these guidelines, in so far as it is not, as a matter of routine, "do not use positive pressure connectors mechanical valves before needleless risks, benefits and proper management of a foods natural appetite suppressors
thorough assessment of the training."FDA's original assessment supports this recommendation.

Postmarket Surveillance Studies

FDA requires companies that produce positive displacement postmarket surveillance tests needleless connectors. studies clarify these devices in order to limit the risk of infection and the risks and benefits. manufacturers shall provide for the collection of information to patients who have received the patients who have received compared with other types of connectors needleless devices bloodstream infections: for more information, see the FDA Letter infection control professionals.

Reporting problems with FDA

Prompt notification of adverse events to help the FDA identify and better understand the risks associated with medical. If you suspect problems with the use of positive displacement needleless connectors, we recommend a voluntary report, FDA MedWatch safety information and events through the reporting program to a file. medical devices by the FDA for reporting in device action is subject to the staff in their facilities reporting procedures.

Health care providers are invited to inform the port facility also infected control staff, where they have doubts concerning the positive displacement connector into the bloodstream infection needleless.

Contact information:

If you have any questions about communication, contact small manufacturers Division, International and Consumer Assistance (DSMICA) dsmica@fda.hhs.gov or 800-638-2041.

For more information about:

This document reflects the FDA in accordance with the information available to the public are informed of the ongoing safety reviews of medical devices in order to reinforce our commitment to the nature of the current analysis., and this situation will not be liable for any public health effects are not yet clear.

Thursday, October 14, 2010

Public Workshop-Medical device User fee program public meeting, 14. September 2010

August 27: Added Webinar PresentationsAugust 26: Updated Agenda and LocationThe purpose of the workshop is to provide an opportunity for stakeholders to present their views on the medical device user fee program. We welcome this opportunity to hear from stakeholders as we begin the next reauthorization process.The meeting will be held at:The Marriott Inn and Conference Center, UMUC 3501 University Blvd E Hyattsville, MD 20783 Phone: 301-985-7300 www.marriott.com/wasum[Back to Top]The Food and Drug Administration (FDA) is announcing a public meeting on the medical device user fee program, originally enacted in the Medical Device User Fee and Modernization Act (MDUFMA), and renewed in the Medical Device User Fee Amendments of 2007 (MDUFA). The legislative authority for the medical device user fee program expires in September 2012. At that time, new legislation will be required for FDA to continue collecting user fees for the medical device program. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that before FDA begins negotiations with the regulated industry on medical device user fee program reauthorization, we hold a public meeting at which the public may present its views on the reauthorization and provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes. FDA invites public comment on the medical user fee program and suggestions regarding the commitments FDA should propose for the next reauthorized program.In the years preceding enactment of Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Public Law 107-250), FDA’s medical device program suffered a long-term, significant loss of resources that undermined the program’s capacity and performance. MDUFMA was enacted “in order to provide the Food and Drug Administration (FDA) with the resources necessary to better review medical devices, to enact needed regulatory reforms so that medical device manufacturers can bring their safe and effective devices to the American people at an earlier time, and to ensure that reprocessed medical devices are as safe and effective as original devices.”1 MDUFMA had a 5-year life and contained two particularly important features which relate to reauthorization:User fees for the review of medical device premarket applications, reports, supplements, and premarket notification maqui berry side effects submissions provided additional resources to make FDA reviews more timely, predictable, and transparent to applicants. MDUFMA fees and mandated appropriations for the medical device program, helped FDA expand available expertise, modernized its information management systems, provided new review options, and provided more guidance to prospective applicants. The ultimate goal was to approve and clear safe and effective medical devices more rapidly, benefiting applicants, the health care community, and most importantly, patients.Negotiated Performance goals for many types of premarket reviews provided FDA with benchmarks for measuring review improvements. These quantifiable goals became more demanding each year and include FDA decision goals and cycle goals (cycle goals refer to FDA actions prior to a final action on a submission). Under MDUFMA, FDA must also have met several other commitments that do not have specific time frames or direct measures of performance, such as expanding the use of meetings with industry, maintenance of current performance in review areas where specific performance goals have not been identified, and publication of additional guidance documents. Medical device user fees and increased appropriations were viewed by FDA, Congress, and industry stakeholders as essential to support high-quality, timely medical device reviews, and other activities critical to the device review program.MDUFMA provided for fee discounts and waivers for small businesses. Small businesses make up a large proportion of the medical device industry, and these discounts and waivers helped reduce the financial impact of the user fees on this sector of the device industry, which plays an important role in fostering innovation.The negotiated performance goals and commitments that did not have specific time frames or direct measures of performance set under MDUFMA were comprehensive and demanding. By FY 2007, a total of 85 performance goals and commitments were in effect. FDA provided periodic reports on its progress towards meeting these performance goals and commitments to its stakeholders and Congress. FDA also provided an annual financial report to Congress to help ensure transparency and accountability of its use of the additional resources provided by MDUFMA.In 2007, Congress reauthorized medical device user fees through fiscal year 2012 under the Medical Device User Fee Amendments of 2007(MDUFA) (title II of the Food and Drug Administration Amendments Act of 2007(FDAAA) (Public Law 110-85).Under MDUFA, the user fee program remained intact, with a few significant modifications to the program. The user fee framework was changed to provide a more reliable and stable funding stream. Specifically, MDUFA included establishment registration as a new fee type which provided a more predictable amount of funds that could be collected by the Agency in any given year. MDUFA also saw changes to the performance goals. Compared to MDUFMA, there were fewer performance goals under MDUFA, yet the goals were more demanding. Specifically, individual cycle goals were removed and tighter overall goals were implemented. This was done to facilitate a more interactive review process. Specific timelines were established under MDUFA for Modular PMAs and Real-Time PMA supplements, which were not established under MDUFMA in 2002.The purpose of the upcoming meeting is to hear stakeholder views on medical device user fee reauthorization as we consider the features to propose in the next medical device user fee program. FDA is interested in responses to the following two general questions and welcomes any other pertinent information stakeholders would like to share:What is your assessment of the overall performance of the medical device user fee program thus far?What aspects of the medical device user fee program should be retained, changed, or discontinued to further strengthen and improve the program?[Back to Top]The following video presentations on the medical device user fee program are designed to give the public more background information on the program. These pre-recorded seminars are in Windows Media Video format, are free of charge, and can be viewed at any time.Overview of User Fees and the Reauthorization Process (Malcolm Bertoni)This presentation provides a general overview of what user fee programs are, how user fee programs work at the U.S. Food and Drug Administration (FDA), and the process to be followed as we work to support congressional reauthorization of the Medical Device User Fee Program in the year 2012. The presentation provides a general overview of how we will engage various stakeholder groups in the reauthorization process, beginning with the September 14, 2010 Medical Device User Fee Program’s Public Meeting.Device Development and Activities Supported by the Medical Device User Fee Program (Donald St. Pierre) This presentation provides an overview of how FDA regulates all types of medical devices and the role of the medical device user fee program in the process.Medical Device Review Program Performance (Barbara Zimmerman) This presentation provides a history of the evolution of the medical device user fee program. It also includes a detailed review of FDA’s medical device review performance under the current medical device user fee program which runs from 2007 through 2012.[Back to Top]September 14, 2010Panel 2 - Health Care Professional PerspectivesPanel 3 - Patient PerspectivesPanel 4 - Consumer PerspectivesPanel 5 - Scientific and Academic Expert PerspectivesPanel 6 - Regulated Industry Perspectives[Back to Top]Transcripts will be posted approximately two weeks after the Public Meeting.[Back to Top]Any person may submit written or electronic comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852 http://www.regulations.gov. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number [Docket No. 2010–N–0389]. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. To ensure consideration, all comments must be received by October 14, 2010.[Back to Top]If you wish to attend this Workshop, you must register by close of business on September 8, 2010.There is no fee to register for the Workshop and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited. However, FDA may limit the number of participants from each organization based on space limitations to ensure representation of all stakeholder interest groups.Individuals who register by August 31, 2010 will receive e-mail confirmation by September 3, 2010. FDA will continue to accept registrations through September 8, 2010 and will provide remaining e-mail confirmations by September 10, 2010. We hope to be able to accommodate all interested parties who wish to attend in person; however, if space does not permit or if travel is a problem, please note that FDA plans to webcast the meeting live through a link on this website.Onsite registration on the day of the meeting will be based on space availability.If you wish to speak during the public comment session at the end of meeting, you must indicate this at the time of registration. FDA will do its best to accommodate requests to speak and will inform speakers, in advance, of the meeting, how much time they will be allotted. If you wish to speak, we recommend that you be available for the entire day as previous public meetings have occasionally moved ahead of schedule.If you need special accommodations due to a disability, or additional information regarding registration, please contact Jim Swink, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-6313, FAX: 301–847–8121, James.Swink@fda.hhs.gov. [Back to Top]James Swink, Food and DrugAdministration, Center for Devices &Radiological Health, 10903 NewHampshire Ave., Bldg. 66, rm. 1609,Silver Spring, MD 20993,301–796–6313,FAX: 301–847–8121,James.Swink@fda.hhs.gov[Back to Top]1 H.R. Rep. No. 107-728, at 21 (2002).

Friday, October 1, 2010

Public Workshop-medical devices and nano-technologies: industry, description, and identify istutteiden, 23. September 2010

This workshop is designed to obtain information to take advantage of nanotechnology, efficiency and safety of medical devices. Specifically, FDA would like to include public input or EU criminal justice area medical devices and Diagnostics nanostructures, including manufacture, a description, and istutteiden assessment. FDA seeks information on these topics and solicit comments on a number of issues.

This workshop will be held on 23.September 2010 at the latest 8 am 5 pm.

Public workshop has been manufactured, keep at the Hilton Washington DC/North Gaithersburg, Maryland, 620 Perry Pkwy, Gaithersburg, MD 20877. Direction, please contact the hotel (301) 977-8900, or refer to their Web site at: www.gaithersburg.hilton.com

Meeting Webcast.

Public Workshop on medical devices and nano-technologies: industry, description, and how to determine whether the draft Agenda istutteiden

Date: September 23

Location:Hilton Washington DC/North Gaithersburg, Maryland, 620 Perry Pkwy, Gaithersburg, MD 20877,

Welcome/design day and logistics Session I medical devices containing or tietoliikenneprotokollat EU criminal justice area or nanostructures (production characterization)

Administrator's introduction of the Session I

-Scientific/regulatory considerations for discussion – [questions discussion] list of CDRH

Medical devices containing or tietoliikenneprotokollat EU criminal justice area or nanostructures manufacture/characterization and quality control (QC) considerations for

Expert speaker presentation (s)

Session I Roundtable discussion Session II: improved electrochemical cells (batteries)/bio-distribution evaluation damp containing or tietoliikenneprotokollat EU criminal justice area or nanostructures

Administrator's introduction of Session II

-Scientific/regulatory considerations for discussion – [questions discussion] list of CDRH

Istutteiden/toxicological considerations for medical devices containing or tietoliikenneprotokollat EU criminal justice area or nanostructures

Expert speaker presentation (s)

Session II Roundtable discussion

The persons concerned must be registered not later than 15 September 2010.

There is no registration fee public workshop. Early registration is recommended, because the seats is limited to the date on which the General seminar, shall be adopted in accordance with the registration of the days from the date of the space available at 7: 30

If you want to make oral presentation at the workshop of making known their views during the sessions (see paragraph (II) additional data FR notice), this must be stated during the registration. FDA request that presentations focus on additional data for FR notice areas defined in section III. What do you want to address your presentation to a discussion topic to be identified. each discussion topic at hand were concentrated in the open session to keep each oral presentation should be treated with only one topic. FDA will do its best to requests to speak. registered participants can send to the contact person of written material oral presentations 5 p.m. 15.September 2010.

If you want to participate in the two planned round-table discussions (see section II FOR additional data FR notice), show that advantage when the registration and shall also produce a brief statement that describes the experience and expertise with the nanotechnologies. number of participants Is johtamismenetelmiä. FDA attempts to be represented in this chat room "constituencies" different. other public workshop attendance is given the opportunity to listen to the discussion of each johtamismenetelmiä and to the public in the comments, time allows.

If you need special Accommodations, please contact disabilidád thanks to Susan 301-796-5661, at susan.monahan@fda.hhs.gov at Monahan of at least 7 days in advance of the meeting.

Daya Ranamukhaarachchi
The Director of the Center CDRH
10903 New Hampshire Avenue
WO-66, room 5574
Silver Spring, MD 20993
(301) 796-6155
(301) 847-8512-Fax
Daya.ranamukhaarachchi@fda.hhs.gov

Tuesday, September 28, 2010

Public Workshop-optimize Clinical Trial Design centre for the development of Pediatric heart devices 30. September 2010

Food and Drug Administration (FDA), the American Academy of Pediatrics (AAP), the American College of Cardiology (ACC), Cardiovascular Angiography and measures (SCAI) and the national institutes of Health (NIH), with the support of the Society is announcing public Workshop on the development of Clinical pediatric heart devices.

Rarely is the equipment developed, evaluated and congenital heart disease, in particular, approved for the treatment of children. Small, heterogeneous population, long-term follow-up is needed because the market incentive and regulatory requirements and the cost-benefit analysis misperceptions are some problems that make trial of the standard control at random from the pediatric Cardiology difficult to implement. The workshop is intended to request information from the clinical, academia, professional associations, other government agencies and industry is one of the best ways to provide an efficient and practical presentation of clinical trial, which will contribute to the development of pediatric Cardiology equipment to overcoming patient population challenges.The data collected in This and future workshops help develop optimal aiheuttavalle pediatric Cardiology device testing instructions. Heart devices specially designed and/or pediatric patients, with the indication of the marketing approval would have a serious impact on public health.

Experts invited deals with a particular focus on models and statistical methods of analysis for the trial version of the clinical trials in the type (s) and clinical information that will help you in this population of patients, in particular, the challenges of alternative sources of supply. each section after the question and answer session is an audience and panel discussion will allow participants to interact with the workshop speakers and panelists. conclusions session allows other interactions.

This meeting will be held September 30 th, 2010, 8: 00 a.m., at the following location:

Romance Center, room 102
747 Howard Street
San Francisco, CA 94103,

The meeting is not videotaped or webcasted.

TimePresentation TitleSpeakerAffiliationChief Pediatrics medical officer
Center for devices and radiological (CDRH)
The u.s. Food & Drug Administration (FDA) Overview of pediatric device regulatory issuesBiomedical engineer, scientific reviewer
DIVISION of cardiovascular equipment (DCD)
CDRH
Funding support available through the NIH pediatric Cardiologist FDATypes developmentPediatric device
Funding/support through the FDA/for pediatric device OOPD developmentMedical officer NIH-NHLBI-Pediatric Heart NetworkTypes
Office orphan products Development (OOPD)
FDAChief,
Interventional Cardiology devices Branch (ICDB)
CDRH
Preclinical data planning, clinical trialsChief FDARole
Circulatory support and Prosthetics Branch (CSPB),
CDRH
FDAWhen is the appropriate vs. Control vs. performance goal at random from the clinical trial?medical officer,
DCD, ICDB
CDRH
FDAHow can can be done in pediatric Cardiology RCT?Pediatric Cardiology
Children's Hospital BostonWhat settings exist surgical difficulties to meet the randomizing controls?a member of staff
DCD
CDRH
FDAREPEL-CV-adhesion barrier trialConsider simultaneous randomized surgically controlsPediatric Cardiology
Cleveland ClinicEstablishing performance GoalsPediatric Cardiology
Rush University Medical CenterPediatric Cardiology
Johns HopkinsPanelists: Robert Beekman, m. (Administrator), Pamela Simons (AGA) and above, as well as various speakersBenefits and disadvantages of each Clinical Trial DesignsDivision and biometrics, Office of surveillance and biometrics (OSB),
CDRH,
FDABayesian and a small "n" trial designsDirector,
Biometrics, OSB, Division of
CDRH,
FDATips and tips to increase the size of a small "n" trialsPanelists information: Greg Campbell (Administrator) and Pediatric Heart network speakersLessons Learned single Ventricle reconstruction TrialLessons process Investigator-run TrialsJohns Hopkins children CenterDirector, HUD devices from
OOPD
FDAPanelists: Bram Zuckerman, m. (Administrator), Lynn Mahony, m. (UT West) and Epidemiology, above speakersDivision
OSB,
CDRH,
Impact of the Improved FDAThe register: Pediatric and adult congenital Cardiology, TreatmentsPediatric
Children's National Medical Center;
Chair, effects of steering CommitteeThe challenge records, historical and pediatric Cardiology Mayo ClinicPanelists trialPediatric device present: Charlie Berul, m. (Administrator), Thomas Jones, m. (Seattle Children); Pam Simons (AGA Medical), Fred Tobia (NMT Medical) Tim Rynn (W.L. Gore), and speakers

If you wish to participate in this Workshop, you must register at the close of business day, the 16th.September 2010.

There is no fee to register for the Workshop and registration is first come, first served basis. Early registration is recommended because seating is limited.

Public comments allowed and promoted at a meeting of the open comment during the discussion sessions.

If you need to be paid to the special Accommodations Enable disabilidád Lynn Colegrove, AAP, at 847-434-7820. If you need more information about registration, please contact Francesca Joseph, m., orphans Office Products Development, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32 Silver Spring, MD 20993, 301-796-6805, FAX: 301-847-8621, francesca.joseph@fda.hhs.gov.

Is in the hotel rooms block (Sept 29) on Wednesday and Thursday (Sept 30) can be called AAP housing 800 468-6322 (U.S./Canada); (415) 979-2290 (International) or call the Hotels directly (Hotels list: https://www.cmrhousing.com/aap_2n/hotellist.aspx)

For more information about this meeting of the contact:

Francesca Joseph
Food and drug administration
Office orphan products Development
10903 New Hampshire Avenue, Bldg. 32 5277, Rm.
Silver Spring, MD 20993
Phone: 301-796-6805
Email: francesca.joseph@fda.hhs.gov