New and Noteworthy

  • Did you know accelerometers are used in some medical devices?  Medical applications include Zoll’s AED Plus and Zephyr Technology Corporation’s BioHarness. Zoll’s AED Plus uses CPR-D padz which contain an accelerometer to measure the depth of CPR chest compressions. In the BioHarness, the signal from an internal tri-axis accelerometer is digitized and analyzed using proprietary algorithms to determine activity and body orientation. Follow this link to learn more about the history and applications of the accelerometer!
  • The slides for the Medical Devices 101 educational forum held on August 26, 2019 can be found here.
  • The Food and Drug Administration (FDA) is proposing to reclassify ultraviolet (UV) lamps intended to tan the skin from class I (general controls) exempt from premarket notification to class II (special controls) and subject to premarket notification, and to rename them sunlamp products. FDA is also designating special controls that are necessary to provide a reasonable assurance of the safety and effectiveness of the device. FDA is proposing this reclassification on its own initiative based on new information. [Proposed Order]
  • FDA posted an interesting video on Regulatory Science
  • Did you know that you can now submit online a request for information to the FDA under the Freedom of Information Act (FOIA)?
  • FDA CDRH issues a new draft guidance: “Refuse to Accept Policy for 510(k)s” [PDF]
  • FDA issues a “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program” Guidance Document [Guidance]
  • FDA publishes guidance on considerations used in device approval, de novo decisions [Guidance]
  • How FDA’s Science and Engineering Labs Solve Public Health Problems: The Huber Needle Story [Video]
  • Networking, Social Media, and staying informed:

Get Adobe Reader