By Brian Craig, J.D.
In an effort to ensure the quality and data from clinical investigations, the FDA has issued a final rule requiring medical device clinical investigations conducted outside the U.S. to conform to good clinical practice (GCP) standards. The FDA is also amending the regulations for premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, investigational device exemption (IDE) applications, and premarket notification submissions.
The rule, with an effective date of February 19, 2019, conforms with international standards for the protection of human subjects for international harmonization (Final Rule, 83 FR 7366, February 21, 2018).
Proposed rule. The FDA published a proposed rule in 2013 to revise the criteria for acceptance of data from clinical studies conducted outside the U.S. (78 FR 12664). The proposed rule also addressed revisions to identify criteria for acceptance of clinical data for all applications and submission types for medical devices.
The FDA received comments on the proposed rule from medical device manufacturers, academia, trade associations, one drug manufacturer, and one consumer. The comments were supportive of GCP for medical devices as a mechanism to help ensure the quality and integrity of the data obtained from clinical investigations and human subject protection. Many comments, however, raised concerns about the proposed rule and some believed the rule was premature. The FDA considered all comments received on the proposed rule and made several important changes, primarily for clarity and accuracy, to reduce burden, and to provide flexibility in meeting regulatory requirements.
Flexibility. The FDA believes the requirements outlined in the rule allow the flexibility needed to accommodate the laws and regulations of other countries. The rule does not identify a specific GCP standard for sponsors and applicants to follow. Instead, the rule includes a definition of GCP which is consistent with the definition in 21 C.F.R. section. 312.120, which embodies well recognized GCP principles and has been generally accepted. This allows sponsors of clinical investigations conducted outside the U.S. to determine an appropriate GCP standard to use for clinical investigations that will produce data to support an IDE or a device marketing application or submission to the FDA. The rule helps to ensure that the data and results from the investigations are credible and accurate and that the rights, safety, and well-being of human subjects are adequately protected, while also being sufficiently flexible to accommodate differences in how countries regulate the conduct of clinical investigations.
Consistency. The FDA also believes the amendments will provide for consistency by ensuring that FDA requirements for acceptance of data from clinical investigations conducted outside the U.S. are the same for all device marketing applications and submissions. The final rule provides consistency in FDA requirements for acceptance of data from clinical investigations, whatever the application or submission type. This will help to provide greater assurance of the quality and integrity of the data from such investigations submitted in support of this type of device marketing submission.
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