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
Dermal Fillers (Soft Tissue Fillers)
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
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