A new draft guidance document issued by the US Food and Drug Administration (FDA) seeks to establish a framework for the use of voluntary consensus standards in medical device premarket submissions.
FDA regularly establishes its own standards, such as through regulation or guidance documents, which product sponsors are expected to follow.
However, it also regularly looks to standards set by outside bodies of experts, and adopts those standards in a process known as incorporation by reference. Those standards can be recognized either in their entirety or in part, such as when FDA intends to supplement an established standard with its own interpretation.
The use of the standards can be beneficial to both industry and regulators alike, FDA explained in a recent Federal Register notice.
"The use of consensus standards can increase predictability, streamline premarket review, provide clearer regulatory expectations, and facilitate market entry for safe and effective medical products," FDA wrote. "Consensus standards provide a consensus approach to certain aspects of the evaluation of device safety and effectiveness, such as testing methods, pass/fail performance criteria, and processes to address areas, such as risk management and usability."
The standards can also promote harmonization across international regulatory regimes, FDA added.
FDA's latest draft guidance document, Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices, is intended to connect theory-why a sponsor would declare conformity to a standard-to the application of standards to medical products.
At its outset, FDA's guidance explains that a consensus standard is not the be-all and end-all of a submission. Declaring conformity to a standard is only a single part of a complex, multi-faceted application, FDA explained.
Further, it's important that the standards be used appropriately-something that doesn't always happen, FDA said.
"FDA's experience with premarket submissions indicates that submitters do not always use consensus standards appropriately," the agency wrote. "For example, submitters may use a version of a consensus standard that FDA does not recognize, or may not realize that only certain aspects - not all - of a particular consensus standard have been recognized by FDA. In addition, submitters sometimes attempt to use consensus standards that do not apply to the particular type of device or testing performed."
If a company declares conformity to a standard, it must declare conformity to the whole standard, FDA explains in the guidance. However, a company may use a standard along "general use" terms, which may allow it to reference the standard in part, which may-or may not-be useful for the premarket submission of a device. This can be useful if there is no FDA-recognized standard for a device, FDA noted.
What's Needed, and What's Not
For sponsors who do declare conformity to a standard, FDA needs specific information. In particular, it needs to see the following in a premarket submission:
- the identity of the standard, including any amendments cited, and whether it is recognized by FDA
- how a sponsor incorporated the standard, such as the use of optional pathways within the standard
- justifications for any deviations from the standard
- justifications for any differences between the tested device and the device to be marketed
The guidance recommends that testing be conducted on a finished device-one "suitable for use or capable of functioning" (21 CFR 820.3(1)) and the same as the one intended to be marketed.
Most standards will not require the submission of underlying data, FDA says in the guidance. Standards that are not recognized by FDA or are not well-suited to the device will generally be required to be accompanied by underlying data, however.
FDA's guidance also notes that for long-running development programs, a standard may change from the time a product is tested to the time it is submitted to FDA. In such cases, a transition period may be established by FDA to allow the continued use of the old standard. Sponsors should be aware of these transition time periods to ensure they do not need to re-test their products.
FDA also maintains a database of recognized consensus standards, which should be referenced in the device application.
Comments on the draft guidance will be accepted by FDA until 10 August 2014.