The Food and Drug Administration has sent a warning letter to Anulex Technologies, a medical device company specializing in spinal products, regarding clinical trials of its Xclose tissue repair system.
In order to use any medical device on study participants, the sponsor must submit an investigational device exemption to the FDA. According to the warning letter, Anulex failed to submit the IDE to the FDA for approval before using the spinal product, considered by the federal agency as a significant risk device, in a clinical investigation involving 750 participants.
The warning letter also states Anulex failed to keep within the investigational scope of the clinical trial. The FDA considers devices marketed for an intended use of annulus fibrosus repair to be class III devices, requiring a premarket approval application. Though the Xclose system was approved by the FDA for the intended use of soft tissue approximation for orthopedic surgery, the product was trialed as a medical device for annulus fibrosus repair, and Anulex never submitted a PMA application.
Anulux also inappropriately marketed Xclose as a "simple, convenient method for treating the compromised soft tissue of the annulus fibrosus," which is in direct violation of the agency's regulation for commercial distribution. Anulex also failed to obtain adequate signed investigator agreements for each participating investigator in a clinical study, according to the warning letter.
Read the FDA's warning letter to Anulex about its Xclose tissue repair system.
Read other coverage about the FDA:
- Smith & Nephew Responds to FDA Letter of Warning
- FDA Warns Against Bisphosphonates for Osteoporosis Medication
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In order to use any medical device on study participants, the sponsor must submit an investigational device exemption to the FDA. According to the warning letter, Anulex failed to submit the IDE to the FDA for approval before using the spinal product, considered by the federal agency as a significant risk device, in a clinical investigation involving 750 participants.
The warning letter also states Anulex failed to keep within the investigational scope of the clinical trial. The FDA considers devices marketed for an intended use of annulus fibrosus repair to be class III devices, requiring a premarket approval application. Though the Xclose system was approved by the FDA for the intended use of soft tissue approximation for orthopedic surgery, the product was trialed as a medical device for annulus fibrosus repair, and Anulex never submitted a PMA application.
Anulux also inappropriately marketed Xclose as a "simple, convenient method for treating the compromised soft tissue of the annulus fibrosus," which is in direct violation of the agency's regulation for commercial distribution. Anulex also failed to obtain adequate signed investigator agreements for each participating investigator in a clinical study, according to the warning letter.
Read the FDA's warning letter to Anulex about its Xclose tissue repair system.
Read other coverage about the FDA:
- Smith & Nephew Responds to FDA Letter of Warning
- FDA Warns Against Bisphosphonates for Osteoporosis Medication
- Zimmer Receives FDA Clearance for Cervical Interbody Fusion Device