On February 25, 2013, the Food And Drug Administration (FDA) issued proposed rules to amend its regulations on acceptance of data from clinical studies in support of medical device applications. The FDA noted that current regulations permit data from clinical studies conducted outside the United States (OUS) to be used in furtherance of premarket approval (PMA) applications, but that regulations for 510(k) submissions do not address the requirements for acceptance of data from clinical studies conducted OUS or inside the United States. 

The FDA indicated that it “believes the requirements for [its] acceptance of data from clinical studies should be consistent regardless of the type of submissions or application in which the data are submitted to FDA.” The FDA has, through these proposed regulations, expressed its intent to ensure the quality and integrity of data and to standardize human subject protections.  One of the more notable changes is the FDA’s proposed mandate that, to be in conformance with international standards of good clinical practices, a study must include documentation of review and approval of the study by an independent ethics committee (IEC).  

While industry has expressed its overall support of the effort to standardize requirements for clinical trials, members of the medical device community have also raised a number of concerns that are fairly consistent across commentaries: 

  • The FDA proposes to require entities OUS to follow FDA requirements without involving key stakeholders OUS in establishing and agreeing upon these requirements.
  • The FDA fails to define key terms such as “clinical studies” and what would be considered an “adequately constituted” IEC or sufficient “qualification of IEC members.”
  • The FDA appears to impose requirements on sponsors for studies conducted OUS that it does not impose on studies conducted within the United States, such as the requirement to verify the adequacy of a foreign IEC.
  • Industry proposes that the FDA should incorporate a waiver provision whereby studies currently underway, or those undertaken within a certain time frame after adoption of new standards, would not be affected retroactively by adoption of any new clinical investigation standards.  

The medical device industry is concerned that the FDA has prepared the proposed rules without collaborating with regulatory agencies, manufacturers, and clinical investigators to ensure the ultimate cooperation by OUS entities and to ensure a common understanding of the regulatory mandates proposed, especially given the ambiguous nature of many key terms and requirements. The process undertaken by the FDA in the current medical device context is unlike that previously used when good clinical practice guidelines were established for the drug and biological product industry. There, the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was established through international collaborative efforts of all key stakeholders. Without similar involvement in the medical device context, there is a concern in the medical device industry that the same level of cooperation will not be achieved as has been seen in the pharmaceutical context.