The US Food and Drug Administration (FDA) on Monday asked stakeholders for input on its planned pilot program for accrediting medical device test laboratories in an effort to boost device makers' ability to rely on conformity to recognized standards to support premarket submissions.
As part of the agency's negotiations with industry for reauthorizing the Medical Device User Fee Amendments (MDUFA), FDA agreed to establish a program for accrediting test labs that evaluate devices for conformity to FDA-recognized consensus standards.
While FDA currently recognizes a broad variety of standards developed by organizations such as the American National Standards Institute (ANSI), International Organization for Standardization (ISO) and International Electrotechnical Commission (IEC), the agency says the use of consensus standards in device submissions "has not been consistently applied by sponsors."
"Many standards are highly complex and require substantial specialized knowledge to interpret and apply correctly. This is a challenge for manufacturers and FDA alike," the agency writes.
According to the MDUFA IV agreement, FDA "intends to rely on the results from the accredited [test lab] for the purpose of premarket review (i.e., generally accept a determination that a device conforms with the standard) without the need to address further questions related to standards conformance."
The agreement also stipulates that a device maker's internal test lab could be accredited and participate in the program, and FDA says it will not review reports from accredited test labs "except as part of a periodic quality audit" or if the agency learns of new information relevant to a device's safety or effectiveness.
FDA plans to pilot the program, referred to as the Accreditation Scheme for Conformity Assessment (ASCA), by the end of FY2020 and has agreed to develop draft guidance on accrediting, reaccrediting and suspending the accreditation of accreditation bodies and test labs by the end of FY2019.
In preparation for the pilot, FDA is asking stakeholders which standards should be included to ensure manufacturers are willing to participate, what impact they would like to see the program have, and what challenges related to consensus standards the agency should focus on during the pilot.
The agency says it is also interested to learn how familiar stakeholders are with existing standards for test labs, such as ISO/IEC 17025 (General requirements for testing and calibration laboratories) and ISO 15189:2012--Medical Laboratories--Requirements for quality and competence, and whether or not they are accredited to those standards.
Other challenges the agency seeks to address include whether it should act as an accreditation body in situations where no private accreditation bodies exist for a standard and what assessment techniques for complex standards (such as those for risk management, quality management and cybersecurity) should be included in the pilot.