FDA Issues Draft Guidance on Vitamin B7 Testing in IVDs
The FDA released draft guidance on testing for biotin (vitamin B7) interference in in vitro diagnostics used in donor screening.
The agency said it has become aware of potential biotin interference with IVDs that use biotin/avidin interactions as part of the device technology. Biotin in patient samples can cause falsely high or falsely low results, depending on the test.
The draft spells out how the agency would like the testing to be performed and how the results of the testing should be communicated to end users, including clinical laboratories and clinicians.
Read the draft guidance here: www.fdanews.com/06-21-19-BiotinInterference.pdf.
OriGen Draws FDA Warning for Device Reworking Practices
OriGen Biomedical has been hit with a warning letter following the FDA’s inspection of its Austin, Texas facility, which revealed problems with the company’s controls for reworked products.
The agency, which inspected the site from June 11 to July 5, 2018, noted that the firm’s documentation of device reworking and reevaluation activities lacked an investigation into any adverse effects that resulted from the rework.
The FDA took issue with the firm’s rework of its VV14F dual lumen catheters, which were released and distributed despite failing endotoxin testing. The rework included a second ethylene oxide sterilization, but the facility failed to document that this had no adverse effect on the devices.
Read the warning letter here: www.fdanews.com/06-21-19-OriGenBiomedicalWL.pdf.
Devicemaker Admits it Failed to Report Wound Dressing Recall
Maryland-based device manufacturer ACell pleaded guilty to a single misdemeanor count of failing and refusing to report a removal of their MicroMatrix powder wound dressing product — and will pay $15 million to settle the matter.
The Department of Justice said ACell failed comply with the FDA’s postmarket compliance requirements when it neglected to alert the agency about the recall, putting patients at risk. The company has agreed to enter into a five-year agreement that requires implementation of a risk assessment and an internal review process.
“By not notifying the FDA nor being forthcoming about their reasons for the product removal, ACell executives placed profit above patient safety,” said Acting FDA Commissioner Ned Sharpless.