ENFORCEMENT ACTIONS

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Inova Genomics Laboratory Warning Letter

Marketing in the US without marketing clearances or approvals, in violation of the Federal Food, Drug, and Cosmetic Act
  • MediMap ADHD, MediMap Mind, MediMap Plus, MediMap Heart, MediMap Baby
  • Being marketed as genetic tests for predicting medication response, reducing negative side effects,  discovering the right drug and right dose for a patient…
  • MediMap tests are devices based on intended uses
  • Clinical validity  not established for their intended uses
  • Pose significant public health concerns- inaccurate test results could impact the decision-making of healthcare providers and patients, seriously detrimental to patient health

Not considered as a Lab Developed Test (LDT) that is exempt from FDA’s premarket review or labeling requirements

WARNING: Inova Genomics


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High Duodenoscope Contamination Rate

  • Postmarket surveillance studies by  all three manufacturers (Fujifilm Medical Systems USA, Inc, Olympus Medical Systems Corporation, Pentax of America)
  • Evaluate % duodenoscopes which remain contaminated after use of labeled reprocessing instructions
  • Preliminary results (3/2019) indicate higher than expected levels (0.4%)  of contamination
  • Root cause analyses are currently underway; importance of strictly adhering to manufacturer’s reprocessing and maintenance instructions

SAFETY: Duodenoscope Reprocessing


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Unapproved or uncleared Apps for concussion

Potential serious risks associated with use of unapproved or uncleared Apps 

  • Marketed to coaches or parents for use during sporting events
  • Could result in an incorrect diagnosis, potentially leading to person with serious head injury returning to their normal activities instead of getting medical care
  • FDA became aware of violative products being marketed to consumers – asked to  remove such claims
  • Will continue to monitor marketplace for devices making unsubstantiated claims and will take further action if necessary
  • Limited number of medical devices that have been FDA cleared or approved to aid in the diagnosis, treatment, or management of concussion – all require evaluation by health care professional

WARNING: Concussion Assessment


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Previously Owned Test Strips or Test Strips Not Authorized for US Sale

Marketing of pre-owned test strips or test strips not authorized for sale in the U.S.

  • Sold through online marketplaces- Amazon, eBay, Craigslist, or directly from seller
  • Pre-Owned Strips :  Unsafe, poor storage, tampering, infection risk from previous owner’s blood – Inaccurate test results
  • Test strips not authorized for US sale: Suboptimal quality, inaccurate results

WARNING: Glucose test strips


Image credit: FDA

 

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