FDA’dan klinik çalışma medikal ekipman verisinin kabulüne yönelik düzenlemesini değiştirme önerisi (İng)
FDA issues proposed rule for Medical Device Clinical Trial Data
The Food and Drug Administration (FDA) is proposing to amend its regulations on acceptance of data from clinical studies for medical devices. FDA is proposing to require that clinical studies conducted outside the United States as support for an investigational device exemption (IDE) application, a premarket notification (510(k)) submission, a premarket approval (PMA) application, a product development protocol (PDP) application, or a humanitarian device exemption (HDE) application be conducted in accordance with good clinical practice (GCP), which includes obtaining and documenting the review and approval of the study by an independent ethics committee (IEC) and obtaining and documenting freely given informed consent of study subjects. The proposed rule is intended to update the standards for FDA acceptance of data from clinical studies conducted outside the United States and to help ensure the protection of human subjects and the quality and integrity of data obtained from these studies. As part of this proposed rule, we are also proposing to amend the IDE and 510(k) regulations to address the requirements for FDA acceptance of data from clinical studies conducted inside the United States. The proposed amendments are intended to provide consistency in FDA requirements for acceptance of clinical data, whatever the application or submission type.
The primary proposed changes include:
- Requiring that clinical studies conducted outside the United States to support any submission to FDA, including a 510(k) or IDE, be conducted in accordance with good clinical practices (“GCPs”);
- Adopting a definition of GCPs;
- Amending the IDE and 510(k) regulations to address requirements for FDA acceptance of data from clinical studies conducted within the United States;
- For PMAs, updating standards for accepting data from outside the United States by replacing the requirement to be in compliance with the Declaration of Helsinki with compliance with GCPs;
- Amending Parts 807 and 812 to incorporate GCPs into the requirements for FDA acceptance of data from studies outside the United States to support a 510(k) or IDE; and
Amending Part 812 to impose different requirements for nonsignificant risk versus significant risk studies conducted outside the United States, mirroring the current IDE regulations.