Automated noninvasive blood pressure monitors: a Food and Drug Administration review perspective
Automated NIBPs, including those in kiosk format, are currently regulated as class II (moderate risk) medical devices. Most class II devices, including NIBPs, are medium-risk devices that by law must be cleared through the 510(k) premarket notification process whereby new devices must demonstrate ‘substantial equivalence’ to a legally marketed device that is not subject to premarket approval (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=870.1130). As these devices are not implanted, are not life-sustaining, and are not life-supporting, FDA has determined that NIBPs are class II medical devices.
Standards are routinely developed by knowledgeable industry, academic and regulatory experts in international bodies to allow more efficient and consistent evaluation of medical devices. The vast majority of NIBP devices have conformed to voluntary consensus standards that ensure the basic safety, essential performance, and clinical validity of these devices. Whether complying with the previous Association for the Advancement of Medical Instrumentation (AAMI) SP10 standard, or the current AAMI/ANSI/ISO 81060-2 (American National Standards Institute/International Organization for Standards) (http://my.aami.org/aamiresources/previewfiles/8106002_1306_preview.pdf) and AAMI/ANSI/IEC 80601-2-30 (International Electrotechnical Commission) (http://webstore.ansi.org/RecordDetail.aspx?sku=ANSI%2fAAMI%2fIEC+80601-2-30%3a2009+and+AM+1%3a2013), all NIBP manufacturers must demonstrate basic safety and essential performance and be subjected to a clinical validation as part of demonstrating substantial equivalence to a predicate device. The standards currently do not require the testing to be completed by an independent third party. It should be noted that multiple clauses in 80601-2-30 are related to identification of the cuff size on the outside of the device and ensuring users know how to properly apply the device. In addition, clinical validation protocols and acceptance criteria identified in 81060-2 are very prescriptive and detailed. This process enables the FDA review team to analyze this information without the need to consult qualified experts outside the agency. However, this process does not preclude the agency from soliciting external comments when the need arises. Finally, if a manufacturer elects not to comply with the voluntary standards previously listed, the manufacturer would still be required to demonstrate basic safety and essential performance, including completing an equivalent clinical validation.
Dr. Alpert has also raised concerns about FDA evaluation of a ‘change’ to a previously cleared class II device. A manufacturer who has other previously cleared devices may submit a 510(k) submission for a new device based on the design of existing devices. Changes that may affect the device’s blood pressure algorithm or components related to the measurement, such as the cuff, would likely require bench and clinical testing. In certain circumstances, such as changes to the outer shell, changes to the number of users or memory, or the addition of wireless communication, FDA would not require a new complete set of testing. Instead, FDA review would focus on those changes made to the device and require testing or information to demonstrate the device continues to be substantially equivalent to the identified predicate. FDA would rely on the information and testing from the predicate device and consider it applicable to the new device where appropriate. Importantly, FDA would not require clinical validation in the examples listed above if the changes did not affect the device’s blood pressure algorithm or components related to the measurement such as the cuff. It should be noted that the approach discussed above is a typical application of the FDA 510(k) review paradigm.