<!– –> <!– Page Last Updated: 04/01/2016 –> Page Last Updated: 04/01/2016 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Update to Interference between CT and Electronic Medical Devices
The probability of an adverse event to pacemakers and ICDs from CT exposure is extremely low. However, as a precaution, you should check the device after it was exposed to CT x-ray radiation, at the next scheduled patient checkup. Although rare, the following adverse effects have been reported: Power on reset (“device reboot”) Battery depletion…
Updates and Enhancements to eMDR – Electronic Medical Device Reporting
CDRH Industry: Get e-mail updates eMDR News Guidance for Industry, User Facilities and FDA Staff: eMDR – Electronic Medical Device Reporting Final Rule on Electronic Medical Device Reporting (eMDR) Electronic Medical Device Reporting (eMDR) On Feb. 13, 2014, the FDA published a final rule on Electronic Medical Device Reporting (eMDR) that requires manufacturers and importers…
Class I Medical Device Recall: Cook Medical Recalls Central Venous Catheter and Pressure Monitoring Sets and Trays due to Tips that May Split or Separate
<!– –> <!– Page Last Updated: 03/30/2016 –> Page Last Updated: 03/30/2016 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Mammography Facility with Revoked MQSA Certificate – March 4, 2016
%PDF-1.7 % 71 0 obj stream xks6e_78I=Mf4{7sm?(X”;Maw”E$bX
New UDI Modules added to CDRH Learn
Premarket Notification (510k) The 510(k) ProgramPresentation Printable Slides Transcript Premarket Notification 510(k) OverviewPresentation Printable Slides 510(k) Format Guidance, Including Standards Form, and Extensions/Clinical Trial Form and 510(k)Presentation Printable Slides 510(k) Third Party ReviewPresentation Printable Slides 510(k) Electronic Submission Pilot ProgramPrintable Slides Transcript De Novo De Novo ProgramPresentation Printable Slides Transcript Clinical Studies/Investigational Device Exemption (IDE) IDE…
The FDA Recommends Against Using OxySure Portable Emergency Oxygen System, Model 615: FDA Safety Communication
Date Issued: March 29, 2016 Audiences: Consumers, health care providers, businesses and schools that have or are considering purchasing the OxySure Portable Emergency Oxygen System, Model 615 Health care providers who recommend OxySure Portable Emergency Oxygen System, Model 615 Device: OxySure Portable Emergency Oxygen System is intended to produce oxygen for emergency use. No prescription…
Heater-Cooler Devices
Heater-cooler devices are often necessary for use during surgeries to warm or cool patients as part of their care. They are especially important tools for surgeries involving the heart, lungs, esophagus, and other chest organs (cardiothoracic surgeries). Heater-cooler devices, as shown below in Figure 11, include tanks that provide temperature-controlled water to external heat exchangers…
Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN140017 added)
<!– –> <!– Page Last Updated: 03/22/2016 –> Page Last Updated: 03/22/2016 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Transcripts posted for February 25-26, 2016 Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee
<!– –> <!– Page Last Updated: 03/22/2016 –> Page Last Updated: 03/22/2016 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.