FDA Clinical Trial Inspection

FDA Clinical Trial Inspection

                       Introduction

A medical manufacturer company in the US conducted a clinical trial on their new product. Based on the risk assessment, the new product got placed under the class II category during the assessment. The FDA investigated the medical premises to ascertain that the submission handed in by the facility was true to the record. The second objective of this inspection was to ascertain that no harm occurred to the test subjects.

Possible Outcome of the FDA inspection

All the necessary IRB and FDA pre-approvals were either complied with or not by the manufacturer.

The manufacturer has full records of the pre-signed agreements with the assessors participating in the investigation.

Will the scenario be assessed under the IDE or GCP compliance?

The clinical trial was to be conducted under the IDE compliance because the device was to be utilized in an assessment study to determine its effectiveness and its safety compliance.

Issues identified from the trial

• The medical facility did not acquire the necessary certification from the Institutional Review Board (IRB) and failed to get clearance from the FDA (Anu, 2020).
• The participating assessors had not signed the necessary agreement form before the trial, and no complete records of the device disposition had been kept (Anu, 2020).

FDA’s response to the inspection

The device will be withdrawn from the market. The manufacturer failed to adhere to the application requirements; furthermore, they failed to get IRB approval or clearance from the FDA.

Conclusion

The clinical trial got conducted as per the regulations, and the manufacturer failed to meet the required threshold. The manufacturer should have known the requirements before conducting a clinical trial. The device should, therefore, get withdrawn from the market. Any plans to conduct the trial mentioned above should get done correctly.

Reference

Anu Gaur. “Medical Development: A Regulatory Overview.” (2020) pp. 5-136