Estar Technologies Ltd - 716831 - 04/22/2026
The FDA issued a communication to Estar Technologies Ltd regarding the distribution of adulterated devices involving Investigational Device Exemptions (IDE) and Premarket Approval Application (PMA) requirements.
Estar Technologies Ltd, as well as regulatory and clinical operations teams managing investigational devices and premarket applications for biologics-related hardware.
The citation for both IDE/PMA violations and 'adulterated device' status suggests a significant failure to maintain the legal and safety standards required for clinical trials or market entry. This may indicate that the device was either distributed without necessary approvals or failed to conform to the quality standards established in its regulatory filings. Such an action typically halts clinical investigations or commercial distribution until remediation is verified by the FDA.
Immediately audit all ongoing investigational studies to ensure IDE/PMA compliance; halt any distribution of devices lacking valid premarket status; verify that all manufactured lots meet the specifications defined in approved applications to avoid adulteration charges.
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Open in openFDA / FDA.gov