TITLE

Should you let surgeons use devices off label?

PUB. DATE
November 2009
SOURCE
Same-Day Surgery;Nov2009, Vol. 33 Issue 11, p110
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
Surgeons can decide to use a medical device in a manner that has not been approved by the Food and Drug Administration (FDA), if steps are taken to protect themselves, their patients, and their facilities. • Read FDA guidance issued earlier this year on unapproved new uses of cleared medical devices. • Ensure that the data support off-label use of the device and that surgery with an approved device is not an option. • Ensure that informed consent and documentation is thorough.
ACCESSION #
44596026

 

Related Articles

  • Rules and Regulations: DEPARTMENT OF HEALTH AND HUMAN SERVICES.  // Federal Register (National Archives & Records Service, Office of;6/16/2014, Vol. 79 Issue 115, p34222 

    The article offers information on the rules and regulations issued by Food and Drug Administration (FDA) under U.S. Department of Health and Human Services (HHS) regarding the classification of nonabsorbable expandable hemostatic sponge under medical devices. Topics discussed include the...

  • Bovie Medical seeks 510(k) clearance for BOSS device. PEDERSEN, AMANDA // Medical Device Daily;7/20/2009, Vol. 13 Issue 137, p1 

    The article announces that Bovie Medical has submitted an application for U.S. Food and Drug Administration (FDA) 501(k) clearance for its BOSS medical device. According to Rick Pfahl, vice president of business development at Bovie, the device is capable of delivering radio frequency (RF)...

  • ArthroCare Receives FDA Clearance for Spartan 6.5 Needled Suture Implant.  // Biomedical Market Newsletter;6/9/2011, p482 

    The article reports on the announcement of ArthroCare® Corp. that the U.S. Food and Drug Administration (FDA) has given the clearance for its Spartan™ 6.5 Needled Anchor. It states that the anchor could be utilized in line with the suture passing technology of the company like the...

  • Medtronic Announces 510(k) Clearance for the Aquamantys(r)3 System with Combined Hemostatic Sealing and Cutting Functionality.  // Biomedical Market Newsletter;10/17/2011, Vol. 21, p92 

    The article reports that the U.S. Food and Drug Administration (FDA) has granted Medtronic Inc. with the 510(k) clearance for its Aquamantys 3 System in 2011. It asserts that the transcollation system allows surgeons and operating room staff to improve ease of use. It is said that the technology...

  • When Data's Scarce The Grass Is Greener. Glenn, Christopher // Review of Ophthalmology;Sep2012, Vol. 19 Issue 9, p15 

    An introduction is presented in which the editor discusses various reports within the issue on topics such as the systematic review of studies comparing the European medical device approval process and the U.S. Food and Drug Administration (FDA) approval procedure and the U.S. approval process...

  • Left to their own devices. Volokh, Alexander // Reason;Jan95, Vol. 26 Issue 8, p16 

    Reports that thousands of Americans die every year because the Food and Drug Administration (FDA) denies them access to life-saving medical devices. Submission of `pre-market notification'; More time spent on review of applications; FDA's call for increased regulatory power.

  • FDA seeks public input on medical mobile app oversight project.  // Endocrine Today;Aug2011, Vol. 9 Issue 8, p7 

    The article reports on the plan of the U.S. Food and Drug Administration to gather input from the public regarding its proposed oversight approach for mobile medical applications designed for smartphones and other mobile computing devices.

  • FDA to seek public comment on recommendations to the 510(k) program.  // Infectious Disease News;Sep2011, Vol. 24 Issue 9, p35 

    The article reports on the public comment being sought by the U.S. Food and Drug Administration (FDA) for recommendations to the 510(k) medical device review program.

  • Are you ready? FDA final rules on devices are on the way. Berek, Britton // Health Facilities Management;Sep96, Vol. 9 Issue 9, p56 

    Discusses the regulations issued by the United States Food and Drug Administration (FDA) on how to report incidents involving medical devices. Regulations under the Safe Medical Devices Act; Persons exempted from the act; Reports to be submitted by device-user facilities to the FDA; Submission...

Share

Read the Article

Courtesy of THE LIBRARY OF VIRGINIA

Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics