The US FDA Center for Biologics Evaluation and Research (CBER) finalized the December 2017 draft guidance titled “Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research” today. The guidance makes clear that CBER recognizes the value and proper usage of standards and further encourages the use of appropriate standards in the development and qualification of CBER-regulated medical products. The guidance acknowledges that the use of standards can “provide a more efficient evaluation of regulatory submissions, including investigational new drug applications (INDs), biologics license applications (BLAs), new drug applications (NDAs), investigational device exemptions (IDEs), premarket approval applications, and premarket notifications, supplements, and amendments.” This guidance however does make clear that CBER will not “endorse the activities of specific Standards Development Organizations (SDOs) or recommend specific standards for use in regulatory submissions.”
What about medical devices, particularly that contain software? While the guidance does not address software directly, the guidance does make clear that “use of consensus standards is not mandatory for medical device regulatory submissions unless the consensus standard has been incorporated by reference into a regulation. For devices regulated by CBER, a sponsor or manufacturer of a medical device may use either standards that have been “recognized” by CDRH or non- recognized standards to support regulatory submissions for medical devices.” One should consider that IEC 62304 is a recognized standard by CDRH but use of IEC 62304 is not mandated by the regulations. However, SoftwareCPR would advise the use of an IEC 62304 compliant process for any software developed for use in a medical device since it requires safety risk management activities.
Depending on the intended use, there could be software impact from “Data Standards” and/or “Performance Standards”. The guidance defines data standards may “describe the data elements and relationships necessary to achieve the unambiguous exchange of information between disparate information systems.” Performance Standards “state requirements in terms of required results without stating the methods for achieving those results. A performance standard may define the functional requirements for the item, operational requirements, and/or interface and interchangeability characteristics.”
Download the guidance here: Standards-Development-and-Use-of-Standards-in-Regulatory-Submissions_Final
CDRH maintains a list of Recognized Consensus Standards that can be found at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.
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