• Regulatory NewsRegulatory News

    Adverse Events Push FDA to Recall Portable Oxygen Systems

    The US Food and Drug Administration (FDA) on Tuesday announced that it’s calling on consumers, businesses, schools and health providers to immediately stop using OxySure Therapeutics’ Portable Emergency Oxygen System, Model 615, after the company’s voluntary recall from last year was ineffective. FDA said it has received multiple complaints and reports of adverse events associated with the device’s malfunctions, including insufficient oxygen flow, re-breathing of exhale...
  • Regulatory NewsRegulatory News

    FDA Revises Draft Guidance on Certification Process for Medical Gases

    The revisions on the 2012 draft guidance on the certification process for medical gases includes new discussions on the labeling for final use containers and what documentation is necessary for marketers of a medical gas that are not the original manufacturer or marketer. The revisions are in response to comments made on the initial guidance on certifying medical gases, though FDA says it doesn’t believe the changes will have too much of an impact on industry. Labe...