FDA News: UDI for Class I Devices, HUD IRB Policy, Opana ER Removal, Dermal Fillers Information, Outsmart Poison Ivy – Drug and Device Digest

FDA BRIEF: Week of June 5, 2017

UDI Compliance Dates for Class I and Unclassified Devices

Unique Device Identification (UDI) system established in 2013  to adequately identify devices though distribution and use

Extending  compliance dates for lower-risk medical devices

  • For class I and unclassified devices
  • Not applicable to class I/unclassified implantable, life-supporting or life-sustaining devices – should already be compliant
  • Guidance to provide enforcement discretion policy for labeling, data submission, standard date formatting, and direct mark requirements


Humanitarian Use Devices; 21st Century Cures Act; Technical Amendment

The 21st Century Cures Act removed local Institutional Review Board (IRB) review

  • Rely on a central IRB
  • Investigational Device Exemption (IDE) studies
  • Humanitarian Device Exemption (HDE) devices
  • Same measures and policies to protect patients who are involved in clinical research or are treated with Human Device Exemption (HDE) for HUD


Wrinkle Filler

Dermal fillers are FDA approved medical device implants

  • to create smoother and/or fuller facial appearance including nasolabial folds, cheeks and lips
  • increasing volume of back of hand

NOT approved for breast, buttock augmentation, increase fullness of the feet, implant into bone, tendon, ligament, or muscle

Risks and Serious Adverse Events reported with use

Information for Healthcare Providers and Patients

Approved Dermal Fillers


Endo Pharmaceuticals

FDA Requests Removal of Opana ER for Abuse-Related Risks

FDA requested Endo Pharmaceuticals removal of reformulated injectable Opana ER

  • concern that benefits may no longer outweigh its risks
  • public health consequences of abuse.
  • first time to remove marketed opioid pain medication from sale

FDA decision based on

  • review of all available postmarketing data
  • significant shift in route of abuse (nasal to injection) after product reformulation
  • injection abuse associated with serious HIV and hepatitis outbreaks, cases of  serious blood disorder (thrombotic microangiopathy)
  • March 2017 FDA advisory committee voted that benefits no longer outweigh risks

FDA will continue to examine risk-benefit profile of all approved opioid analgesic products in response to public health crisis



Outsmarting Poison Ivy and Other Poisonous Plants






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