FDA New Proposed Regulations for Clinical Data Submission

The Food and Drug Administration (FDA) is proposing to amend its regulations on acceptance of data from clinical studies for medical devices. They are proposing new requirements for 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 to be conducted in accordance with good clinical practice (GCP).  This will include 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.

Their intent is to update the FDA standards for 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. The FDA is also proposing amendments to 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. Note that comments are due by May 28, 2013

Link to PROPOSED RULE

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