e-cigarettes: Enforcement policy on unauthorized flavored cartridges

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Enforcement policy on unauthorized flavored cartridge-based e-cigarettes that appeal to children, including fruit and mint

FDA intends to prioritize enforcement against these illegally marketed ENDS products by focusing on the following groups of products that do not have premarket authorization

  • Any flavored, cartridge-based ENDS product (other than a tobacco- or menthol-flavored ENDS product)
  • All other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access
  • Any ENDS product that is targeted to minors or likely to promote use of ENDS by minors.

Companies that do not cease manufacture, distribution and sale of unauthorized flavored cartridge-based e-cigarettes (other than tobacco or menthol) within 30 days risk FDA enforcement actions

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Image credit: FDA

Device Authorizations: COBAS MRSA diagnostic, WOUNDCHECK for bacterial status, GSP Neonatal Creatine Kinase for Duchenne, CONTROL-IQ for diabetes

CaptureCOBAS vivoDx MRSA diagnostic test 

Roche Molecular Systems Inc.

INDICATION FOR USE: Automated qualitative in vitro diagnostic test for the direct detection of live methicillin-resistant Staphylococcus aureus (MRSA) cells in nasal swab samples from patients who are at risk for nasal colonization by MRSA.
The test utilizes selective agents and bioparticles (Smarticles technology) to introduce a luciferase gene into targeted bacteria to create an amplified luminescent signal in only viable (live) MRSA cells. The cobas vivoDx MRSA test is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose MRSA infections, nor to guide, or monitor treatment. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing.

ADDRESSING UNMET NEED: New tool in the fight to prevent and control MRSA in high-risk settings

DESCRIPTION: System for detection of microorganisms and antimicrobial resistance using reporter expression

  • New bacteriophage technology based on bioluminescence to detect MRSA from nasal swab samples in 5 hours vs  compared to 24-48 hours for conventional culture

PERFORMANCE TESTING: Test correctly identified MRSA in  90% of samples where MRSA was present and 98.6% of samples with no MRSA

RISKS: Failure to use the device correctly, False positive or negative results, Failure to interpret results correctly

MITIGATIONS: Labeling, Design verification and validation, Other special controls

REGULATORY PATHWAY: De Novo premarket review pathway

CLASSIFICATION ORDER


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WOUNDCHEK Bacterial Status

Woundcheck Laboratories

INDICATION FOR USE: in vitro diagnostic chromatographic test for qualitative detection of bacterial protease activity directly from wound fluid samples collected with a swab. The WCBS test is intended for use in adult patients as an aid in assessing the risk for nonhealing of chronic venous, diabetic foot, and pressure ulcers associated with wounds where there are no signs of wound infection and where patients are asymptomatic for clinical signs of infection. The test is intended for use with chronic wounds that are between 21 days and < 6 months of age and chronic wounds that are ≥ 6 months of age that are < 1cm2 in size.

DEVICE TYPE: To detect bacterial protease activity in chronic wound fluid

  • Lateral flow prescription device that may include a sterile swab
  • Intended for use in patients as an aid in assessing the risk for non-healing of chronic venous, diabetic foot, and pressure ulcers associated with wounds where there are no signs of wound infection and where patients are asymptomatic for clinical signs of infection.

RISKS: Failure to use the device correctly, False positive or negative results, Failure to interpret results correctly

MITIGATIONS: Labeling, Design verification and validation, Other special controls

REGULATORY PATHWAY: De Novo premarket review pathway

CLASSIFICATION ORDER 


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GSP Neonatal Creatine Kinase – MM kit

PerkinElmer

ADDRESSING UNMET NEED: First test to aid in newborn screening for Duchenne Muscular Dystrophy (DMD), a rare genetic disorder that causes progressive muscle deterioration and weakness

DESCRIPTION: Muscular dystrophy newborn screening test

  • Intended to measure creatine kinase levels obtained from dried blood spot specimens on filter paper from newborns (prick of a newborn’s heel 24 to 48 hours after birth) as an aid in screening newborns for muscular dystrophy
  • Kit works by measuring the concentration of a type of protein called CK-MM, which is part of a group of proteins called creatine kinase
  • Creatine kinase is found in muscle tissue and CK-MM enters the blood stream in increased amounts when there is muscle damage

PERFORMANCE: 

  • Clinical study, n=3,041 newborns, dried blood samples tested for DMD associated protein levels
  • Kit able to accurately identify the four screened newborns that had DMD-causing genetic mutations
  • Additional testing of 30 samples from newborns with clinically confirmed cases of DMD; all correctly identified

RISKS: False positive and False negative results

MITIGATIONS: Labeling, Design verification and validation, Special controls

REGULATORY PATHWAY: De Novo premarket review pathway

CLASSIFICATION ORDER


CaptureControl-IQ Technology

Tandem Diabetes Care

INDICATION FOR USE: Intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold.
Control-IQ technology is intended for the management of Type 1 diabetes mellitus in persons 14 years of age and greater.
Control-IQ technology is intended for single patient use and requires a prescription.
Control-IQ technology is indicated for use with NovoLog or Humalog U-100 insulin.

DESCRIPTION: Interoperable automated glycemic controller

  • Intended to automatically calculate drug doses based on inputs such as glucose and other relevant physiological parameters, and to command the delivery of such drug doses from a connected infusion pump
  • Designed to reliably and securely communicate with digitally connected devices to allow drug delivery commands to be sent, received, executed, and confirmed. Interoperable automated glycemic controllers are intended to be used in
    conjunction with digitally connected devices for the purpose of maintaining glycemic control.

RISKS:

  • Inability of the controller to handle different pharmacokinetic and pharmacodynamic characteristics of the drugs
  • Lack of compatibility of connected devices
  • Connected devices having inadequate performance to allow safe use of  controller
  • Failure to report device malfunctions or adverse events to manufacturer
  • Latent flaws in software
  • Failure to provide appropriate treatment due to loss of communication with
    connected devices
  • Risk due to insecure transmission of data
  • Failure to correctly determine the root cause of device malfunctions
  • Data transmission interference/electromagnetic disturbance

MITIGATIONS: Device performance, drug compatibility information in labeling
User training, Validation of processes, and procedures as well as limitations with connected and interoperable devices, Assigning post-market responsibilities. Software validation testing, Electrical safety verification and validation, electromagnetic compatibility,radio frequency wireless testing, user training

REGULATORY PATHWAY: De Novo premarket review pathway

CLASSIFICATION PATHWAY


Image credits:  Roche, Woundcheck Labs, PerkinElmer, Tandem