News and Views: Breast implant safety, E-Cig epidemic, Device submissions in eformat, Voluntary consensus standards for devices – Drug and Device Digest


Agency’s commitment to studying breast implant safety

FDA has worked over decades  to monitor, assess and take action to protect patients with regard to breast implant safety

  • Communicated risks such as capsular contracture, implant rupture and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)
  • However, disagree with claims of increased risk of certain connective tissue conditions, such as rheumatoid arthritis and scleroderma

Streamlining and modernizing postmarket actions to address device safety issues 

  • Coordinated with American Society of Plastic Surgeons and Plastic Surgeons Foundation to develop Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (ALCL) Etiology and Epidemiology
  • Development of the National Breast Implant Registry
  • Meet with patient advocacy group focused on breast implant related issues
  • Public meeting of the General and Plastic Surgery Devices Panel of our Medical Devices Advisory Committee in 2019


New steps to address epidemic of youth e-cigarette use

Didn’t predict epidemic of e-cigarette use among teenagers

  • Disturbing and accelerating trajectory of use in youth, and resulting addiction
  • Launched Youth Tobacco Prevention Plan earlier this year.

Series of compliance actions over the past year

  • In partnership with Federal Trade Commission, targeted misleadingly labeled or advertised e-liquids resembling kid-friendly foods like juice boxes, candy and cookies
  • Warning letters and civil monetary penalties to JUUL
  • >1000 warning letters to stores for illegal sale of e-cigarettes to minors
  • Re-examining the enforcement discretion currently exercised for other e-cig products currently on the market without authorization



Medical Device Submissions in Electronic Format

Proposed rule for medical device premarket submissions to be sent in electronic format, eliminating the need for multiple paper submissions

  • To improve efficiency of premarket submission program



Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices

Appropriate use of national and international voluntary consensus standards (referred to as consensus standards) in the preparation and evaluation of premarket submissions

  • Provide clarity and explanation about the regulatory framework, policies, and practices regarding the appropriate utilization of consensus standards


  • Use of Consensus Standards
    • Use of Declarations of Conformity
    • General Use of Consensus Standards
  • Managing Product Development When Standards Change: Transition Periods
    • Where to Find Information on a Transition Period .
    • When Standards Change Prior to Review of a Premarket Submission .
    • When Standards Change During Active Review of a Premarket Submission
    • Transition Period Expiration
  • Promissory Statements
  • Limitations of Consensus Standards
  • When Devices or Standards Change After Marketing Authorization


Image credits: FDA

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