In 2017, FDA issued only 44 Warning Letters to medical device establishments. Of those, 11 were related to pre-market issues, which include investigational device exemption violations or lack of approval or clearance. Only 33 of the device Warning Letters in 2017 were issued for cGMP, Quality System, or MDR violations, a remarkable figure since FDA regularly sent over 100 device regulation compliance Warning Letters every year from 2011 to 2015.
One might expect that fewer Warning Letters means fewer inspections, but FDA’s inspection database shows that the number of device compliance inspections has remained fairly consistent from 2011 through 2017. The number of inspections has certainly decreased from a high of 1,859 in 2011, but FDA conducted 1,624 device compliance inspections in 2014, 1,533 in 2015, 1,539 in 2016, and 1,551 in 2017. Clearly, the sudden drop off in Warning Letters has been much steeper than the modest decrease in inspections.
What could be driving this decrease in Warning Letters? I briefly explore three possibilities below.
Is FDA’s Approach to Device Enforcement Evolving?
Over the past couple years, FDA issued a slew of new guidance on recent medical device technologies (e.g., clinical decision support and next generation sequencing) and made a lot of changes to its existing medical device guidance documents. Many of the changes in 2017 were prompted by the passage of the 21st Century Cures Act, which exempted certain software products from the Food, Drug, and Cosmetic Act’s definition of “device” and instructed FDA to implement specific new device programs and guidance. These relatively rapid changes resulted in a regulatory whipsaw that kept stakeholders in the device industry, and almost certainly in FDA itself, on their toes.
In the midst of these policy shifts at FDA, it is possible that the agency is taking a different, more cooperative or interactive approach to enforcement activities instead of firing off Warning Letters. Recent medical device technology has, in some ways, outstripped FDA’s capacity to define its regulatory jurisdiction and refine its approach to enforcement. And since everyone, including FDA, is learning and getting used to the new policies, a more moderate approach would allow device manufacturers to explain their processes to FDA.
Are Medical Device Companies More Regulation Savvy?
Progress in the medical device industry has been rapid over the last decade. In particular, the development of software programs as stand-alone medical devices has pushed the boundaries of FDA’s regulations and guidance (e.g., mobile applications for general wellness). In the push to redefine the medical device sector using software and ever-advancing technological capabilities, the groundbreaking companies did not always stop to consider the full regulatory implications of their technologies. Likewise, FDA did not have well-defined regulations or policies to deal with the slew of new technology intended for medical and general health uses.
After a few years of seeing high levels of FDA enforcement, medical device companies may have become more savvy about FDA’s regulatory reach and the possibility of enforcement actions if they openly disregard or flout regulations and guidance, even if the traditional regulations do not seem relevant to their technology. Start-up device companies are also seeing more pressure from investors to have a regulatory plan in place and address any issues before going to market. More device companies may be reaching out to FDA attorneys or consultants to explore possible regulatory hurdles and quality system requirements while devices are still in development rather than waiting until late pre-market or launch phases.
Did the Case for Quality Initiative Contribute to the Drop in Warning Letters?
FDA has been collaborating with the Medical Device Innovation Consortium to develop and run the Case for Quality initiative, which seeks to increase industry awareness of quality issues and incentivize consistent production of high-quality devices. The goal of the Case for Quality is for manufacturers to see higher, consistent device quality a business target rather than simply meeting base-level regulatory compliance standards. The initiative is in early phases and is focusing on developing quality and risk/benefit metrics that can be deployed across the device industry and on pilot programs in companies with established quality records.
So, has this exploratory push beyond ordinary quality system compliance caused FDA to decrease the number of Warning Letters to device companies? Probably not. I spoke with Sean Boyd, Deputy Director for Regulatory Affairs in CDRH’s Office of Compliance, at a conference late in 2017 about the Case for Quality. Boyd said the nascent initiative was not intended to apply a new layer of regulatory compliance to the medical device industry, rather it is meant to help companies with established records of compliance and high device quality to maintain their systems and improve them further and to encourage companies with compliance issues to fix their issues and focus on creating a culture of quality. From this perspective, while it is possible that some companies have implemented dramatic compliance and quality system improvements with the aim of participating in the Case for Quality initiative, it is unlikely that this activity would reach the level necessary to cause such a dramatic decrease in Warning Letters over the past two years, especially when the initiative is only in the pilot phase.
Conclusion
The decrease in the number of Warning Letters to device companies signifies a shift in FDA’s handling of quality system enforcement, but it is not clear what has caused that shift. Is it due to policy change at FDA? Or perhaps device manufacturers are using more resources to engage with FDA and collaborate on acceptable solutions? In the end, it is likely that all of the factors described above contributed to the recent drop in Warning Letters. Many more changes in device enforcement are probably coming as FDA solidifies its positions on recent device technologies. Stay tuned for future updates on this topic.
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