CDRH New Update

The following new items were added to the CDRH web pages on February 22, 2019. Previous CDRH New items can be found on the CDRH New webpage.

• Class I Recall: ICU Medical Recalls ChemoLock Vial Spike (20mm) Due to Risk of Detached Plastic Particles
• Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation - Non-clinical Testing and Clinical Considerations - Draft Guidance for Industry and Food and Drug Administration Staff
• Federal Register: Implanted Brain-Computer Interface Devices for Patients with Paralysis or Amputation--Nonclinical Testing and Clinical Considerations