July 2019 – Drug and Device Digest

News & Views: Software Precert program, Drug shortages and sterilization,CSF shunts & hearing aids, PrEP HIV program, Drug abuse labeling, EU inspection partnership, Weight management devices, Breast implant recall, Regulating E-Cigs


Software Precertification (Pre-Cert) Program Update

Pre-Cert program introduced to streamline regulation of  digital health devices, specifically software as a medical device (SaMD)

Test phase: Excellence Appraisal and Streamlined Review components

  • Mock Excellence Appraisal summary
  • Streamlined Review packages by extracting elements from original submission
  • Mock review on whether regulatory decision could be made


  • Regulatory decision could be made
  • Opportunities to simplify Excellence Appraisal and Streamlined Review process


Capture.JPGPreventing Medical Device Shortages by Ensuring Safe and Effective Sterilization in Manufacturing

Sterilization issues during manufacturing is cause of device shortages; steps to prevent

  • Monitoring  device supply, planning for and preventing potential shortages
  • Engaging with Healthcare Infection Control Practices Advisory Committee (HICPAC)
  • New innovation challenges for ideas from stakeholders, academics, industry
    • new or alternative sterilization methods
    • alternatives to those that use ethylene oxide


Programmable CSF Shunts and Magnetic Field Interference with Implanted Hearing Devices 

Magnetic interactions in patients implanted with both programmable  cerebrospinal fluid (CSF) shunt systems and hearing aids (cochlear implants, bone conduction hearing devices, or middle ear hearing devices)

  • May inadvertently change programmable CSF shunt valve settings
  • Altered mental status, headaches, lethargy, irritability, vomiting, changes in vision, and difficulty walking – could progress to seizures, hemorrhage, or even death


  • Educate patients and caregivers about potential risk
  • Check CSF shunt valve setting after placement or adjustment of other devices
  • Consider different placement of CSF shunt valve if patient has other implanted devices
  • Contact the applicable device manufacturer for further information


Capture.JPGPrEP and additional steps to help reduce the risk of getting HIV

Pre-exposure prophylaxis (or PrEP)  is for people at very high risk of HIV infection

  • Daily doses of Truvada (tenofovir and emtricitabine) that are used in combination with other medicines to treat HIV
  • FDA is  eliminating risk evaluation and mitigation strategy (REMS) for Truvada to improve accessibility  and patient uptake


Capture.JPGEnsuring Patient Safety and Drug Manufacturing Quality Through Partnership with European Union Regulators

Mutual Recognition Agreement (MRA) with EU to more effectively deploy inspectional resources across the globe

  • FDA has completed capability assessments of 28 EU member states
  • Created important efficiencies for risk-based site selection model for inspection
  • Considering to extend beyond human drug products to veterinary products, human vaccines, and plasma-derived drugs



Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products 

The primary role of DRUG ABUSE AND DEPENDENCE section of labeling is to convey information about potential for abuse, misuse, addiction, physical dependence, and tolerance

Controlled Substance : Under the Controlled Substances Act, For Which Controlled Substance Scheduling Is Pending, Not Controlled Under the Controlled Substances Act 

Abuse: Information on Abuse, Misuse, Addiction

Dependence: Information on Physical Dependence and Withdrawal, Tolerance



FDA resources on Weight-Loss and Weight-Management Devices

Therapies for weight-loss or weight-management range from healthy eating and exercise, to prescription medicine, medical devices and surgery.

FDA Webpage provides information about:

Capture.JPGAction to protect women from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)

  • Requested Allergan, manufacturer of BIOCELL textured breast implant, to recall device due to the risk of BIA-ALCL
  • Allergan is moving forward with worldwide recall
  • safety communication for patients with breast implants, considering breast implants and their health care professionals

CaptureSteps to control E-Cigs

  • Restricting youth access to electronic nicotine delivery systems (ENDS, which includes products known as “e-cigarettes”)
  • Conducting retailer and manufacturer checks on restricting sales to youth
  • Increasing Requirements for ENDS Manufacturers for safety
  • Utilizing Premarket Review Requirements for market authorizations

Real Cost campaign


Image credits: FDA, Allergan

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