Open for Comment – FDA Proposes More Consistent Clinical Data

The Food and Drug Administration (FDA) is proposing to amend its regulations on acceptance of data from 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, FDA is 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.

These new requirements would apply to Investigational Device Exemptions (IDE), 510(k) premarket notification and premarket approval (PMA) submissions, product development protocols and humanitarian device exemptions (HDE). Changes to 510(k) and IDE regulations are also being proposed regarding clinical studies within the US.

Medical device clinical studies done in the US to support 510(k), IDE and HDE applications would have to meet the same requirements currently established for PMA applications—including written statements regarding subject safety and data quality.

The FDA is accepting comments on the proposed rule through May 28, 2013. The rule will go into effect 180 days from the date of its publication in the US Federal Register (February 25, 2013).

About Christopher Ford

Christopher Ford is an expert in global medical device manufacturing compliance with over 20 years of experience, specializing in Class II and Class III medical devices and combination products. He is a certified ISO 13485 Lead Auditor, with over 600 audits under his belt, and he works with organizations of all sizes. His approach to compliance requirements balances customer needs with business objectives, while assuring that all regulatory requirements are met.