Enforcement Actions: INOVA Genomics unapproved tests, Duodenoscope contamination, Unapproved Concussion Apps, Reused/Unauthorized Test Strips
ENFORCEMENT ACTIONS
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
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
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
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
Image credit: FDA