News & Views: Cybersecurity, Technology Modernization Action Plan, Implementing SUPPORT Act, Homeopathic products oversight, Breast implants safety, CBD warning for pregnancy, CDRH Patient Engagement, New youth e-cigarette education – Drug and Device Digest


Medical Device Cybersecurity : Information for patients

New technologies can be implantable or wearable, used at home or in health care settings: Safer, timelier and more convenient

Anytime a medical device has software and relies on a wireless or wired connection, vigilance is required : Vulnerable to cyber threats and requires cybersecurity

Patients need to

  • Apply software updates
  • Register device with manufacturer
  • Be observant and vigilant
  • Involve  family or caregivers
  • If there is a serious event, seek medical attention.

Capture.JPGFDA’s Technology Modernization Action Plan (TMAP)

Technological foundation for development of FDA’s ongoing strategy around data

  • For stewardship, security, quality control, analysis, and real-time use of data
  • Will accelerate path to better therapeutic and diagnostic options

Proposal to

  • Modernize FDA’s technical infrastructure 
  • Develop technology products to support FDA’s regulatory mission
  • Communicate and collaborate with stakeholders to drive technological progress that is interoperable across the system


Capture.JPGFDA first year accomplishments implementing SUPPORT Act authorities to address the opioids crisis

FDA’s implementation of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act)

  • Clarifying FDA regulation of non-addictive pain products
  • Evidence-based opioid analgesic prescribing guidelines and report
  • Strengthening FDA and U.S. Customs and Border Protection (CBP) coordination and capacity
  • Restricting entrance of illicit drugs
  • Safety-enhancing packaging and disposal
  • Clarifying FDA postmarket authorities
  • Study on abuse-deterrent opioid formulations access barriers under Medicare


Capture.JPGEfforts to protect patients from potentially harmful drugs sold as homeopathic products

Homeopathic products are marketed without FDA review and may not meet standards for safety, effectiveness, quality and labeling

  • Issuance of draft guidance discussing risk-based enforcement approach to drug products labeled as homeopathic
  •  Withdrawing outdated Compliance Policy Guide (CPG) 400.400, entitled “Conditions Under Which Homeopathic Drugs May be Marketed”

Risk-based approach with appropriate regulatory and enforcement actions when  patients are being put at risk


Capture.JPGEfforts to protect women’s health and enhance safety information available to patients considering breast implants

 Draft guidance  to ensure patients have complete information about the benefits and risks of breast implants

  • Boxed Warning in labeling: Not lifetime devices, chances of developing complications, associated with risk of developing breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)
  • Inclusion of patient decision checklist at end of patient informational booklet
  • Revision of rupture screening recommendations for silicone gel-filled implants
  • Inclusion of product  ingredient information  that is easily understood by patients

To help patients better understand breast implant benefits and risks in making health care decisions that fit patients’ needs and lifestyle 


CaptureWarning against Using Cannabis, Including CBD, When Pregnant or Breastfeeding

FDA strongly advises against use of cannabidiol (CBD), tetrahydrocannabinol (THC), and marijuana in any form during pregnancy or while breastfeeding

Unapproved products and FDA does not know

  • safety and effectiveness to treat a particular disease
  • what, if any, dosage may be considered safe
  • interaction with other drugs or foods
  • whether they have dangerous side effects or other safety concerns


CaptureCDRH Patient Engagement

Mission to engage with patients, understand their perspective, and proactively integrate the patients’ perspectives into the total product life cycle of medical devices 

  • Designing medical devices
  • Planning and conducting medical device clinical investigations
  • Informing CDRH’s thinking on current issues impacting a patient community
  • Helping to identify emerging signals
  • Communicating safety messages
  • Identifying specific populations’ perspectives on benefit-risk for a given treatment

Ways to engage

Contact: [email protected].


CaptureWork  with Scholastic with launch of new youth e-cigarette prevention educational resources for middle and high schools

Education is an important complement to the FDA’s overarching youth tobacco prevention efforts

  • Continuing to educate youth, parents, and teachers about the dangers of e-cigarette use
  • Joined forces with Scholastic to develop and distribute educational resources to high school educators across the country
  • Expanding collaboration with Scholastic to include middle school educators
  • Help ensure that > one million middle and high school teachers have resources to start educational conversations about the harms of e-cigarette use with their students


Image credit: FDA

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