Regulatory considerations for FDA enforcement policies during the COVID-19 public health emergency for medical device manufacturers

This article summarizes FDA enforcement policy during the early months of the COVID-19 public health emergency and outlines the regulatory considerations for temporary enforcement discretions. The authors emphasize the importance of routine and scientific communication between the FDA, industry, and providers to facilitate the long-term directions of these technologies.
 
Introduction
Historically, the US Food and Drug Administration (FDA) has played an important role in the nation’s pandemic responses.  However, public and industry have witnessed an unprecedented level of involvement in medical-device policymaking from the FDA in response to the current COVID-19 pandemic.
 
The first case of 2019 novel coronavirus (2019-nCoV) infection was confirmed in the US on 20 January 2020. By 30 January,  a total of 9,976 cases had been reported in at least 21 countries.¹ As a result of the confirmed cases of 2019-nCoV, the US secretary of Health and Human Services (HHS), Alex M. Azar II, determined on 31 January that, pursuant to section 319 of the Public Health Service (PHS) Act, there was a nationwide public health emergency.² Subsequently, on 4 February, the secretary issued a separate determination and declaration that, pursuant to his authority under section 564(b)(1)(C) of the Federal Food, Drug, and Cosmetic (FD&C) Act, the public health emergency had significant potential to affect national security or the health and security of US citizens living abroad.³
 
After the issuance of several emergency use authorizations (EUAs), the FDA issued its first enforcement discretion guidance document on 20 March, in response to the COVID-19 emergency. Over the next 6 weeks, the agency issued a total of 15 guidance documents on enforcement policy for a number of device types.⁴ This article summarizes trends in FDA policies and regulatory considerations for medical device manufacturers when implementing such policies.
 
Summary of FDA enforcement policy
Two groups of device types that respond to healthcare needs during the COVID-19 pandemic remain the focus of FDA enforcement policy candidates (see Table⁴):
 

• Telemedicine technologies. These are technologies that enable routine and necessary care to be conducted remotely in several specialties, including general vital-signs monitoring, fetal and maternal care, ophthalmology, radiology, and other clinical decision-support tools. FDA’s enforcement policies align with the need to minimize clinical visits for high-risk populations and help reduce virus exposure for healthcare professionals and patients.
• Personal protective equipment (PPE) and ventilators. The focus of guidance documents related to PPE and ventilators is to address changes made to approved products that do not warrant an EUA.

 TABLE. Guidance documents issued to date on enforcement policy during the COVID-19 pandemic, showing device type and product codes.


Regulatory considerations for temporary enforcement discretions
Manufacturers of products covered in FDA’s enforcement policy guidance documents may wish to modify their products in accordance with guidance to support COVID-19‒related efforts. It is important to note that certain FDA-recognized standards for electrosafety, software lifecycle, risk management, and biocompatibility still apply when making modifications to devices that are currently being marketed. In addition, device changes should include appropriate cybersecurity controls according to FDA guidance documents.^5,6 Finally, device-specific standards recognized by the FDA during the design control process should also be considered as outlined in each enforcement policy guidance.
 
In contrast to EUAs, the issuance of enforcement policy guidance documents by the FDA is not contingent on the declaration of an emergency by the HHS secretary for a certain product type. Rather, FDA has played a critical and proactive role in providing such policies to help expand the availability of certain devices. The focus of FDA’s enforcement discretion focus has shifted as healthcare needs during the COVID-19 emergency rapidly change. It is not unreasonable to anticipate that FDA will continue to evaluate its enforcement policies in the future as healthcare needs change and the risk/benefit profile of certain technologies continue to evolve.
 
Enforcement policies, such as EUAs, are intended to remain in effect only for the duration of the COVID-19 emergency, as declared by the HHS secretary under section 319(a)(2) of the PHS Act. Manufacturers should consider the appropriate regulatory pathway for device modifications and plan to file the appropriate 510(k) premarket notification for the modified device to remain on the market after the COVID-19 emergency. For certain modifications that may require new clinical evidence, such as an expansion in intended-use population or a new claim, manufacturers may plan to collect real-world evidence during the COVID-19 emergency to support a 510(k) premarket notification with or without additional controlled clinical study data.
 
Although specific product codes are listed in FDA’s guidance documents, the agency has demonstrated flexibility in enforcement of such discretion for products not listed in the guidance documents. For example, in early April, Dexcom received FDA notification⁷ that the agency would not object to use of its continuous glucose monitoring devices (CGMs) in hospitalized patients during COVID-19‒related efforts. CGM devices are currently labeled for use by patients with diabetes patients in the home environment only. With FDA’s enforcement discretion in this case, use of CGM in the hospital setting helps reduce physical interaction between caregivers and patients with COVID-19. That, in turn, helps reduce PPE usage, which usually would be required during routine fingerstick glucose measurements.
 
Industry, patients, and healthcare providers are encouraged by FDA’s collaborative framework and maximization of regulatory flexibility to speed up the availability of several medical technologies during the COVID-19 pandemic. FDA has enabled rapid access to several innovative solutions to facilitate patient care solutions during the pandemic by exercising its enforcement discretion provisions for several technologies, as outlined in this summary.
 
Manufacturers are also encouraged to use regulatory intelligence to monitor, gather, and analyze ongoing regulatory actions by the FDA to develop a go-to market strategy for their novel solutions. The authors believe there are many more manufacturers with available technologies to assist in the COVID-19 pandemic that are not yet covered by current enforcement discretion guidelines. Manufacturers are encouraged to contact the appropriate review division at the FDA to collaborate in bringing these technologies to the forefront.
 
FDA has committed to consider all COVID-19‒related inquiries or requests by manufacturers, healthcare providers, and other stakeholders expeditiously and carefully. Although FDA continues to respond to the evolving COVID-19 crisis, there will, no doubt, be challenges for both the agency and industry. Frequent and scientific dialog between FDA, industry, and providers will help inform long-term directions of these technologies.
 
Abbreviations
2019-nCoV, the 2019 novel coronavirus; CDC, Centers for Disease Control and Prevention; CGM, continuous glucose monitoring; COVID-19, coronavirus disease 2019; EUA, emergency use authorization; FDA, [US] Food and Drug Administration; HHS, [US Department of] Health and Human Services; PHS, Public Health Service [Act]; PPE, personal protective equipment.
 
References

1. Holshue ML et al. First case of 2019 novel coronavirus in the United States. N Engl J Med. 2020;382(10):929-36.
2. US Department of Health and Human Services. Determination that a public health emergency exists. https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx. A Published 31 January 2020. Accessed 16 June 2020.
3. Federal Register. A notice by the Health and Human Services Department on 02/07/2020. https://www.federalregister.gov/documents/2020/02/07/2020-02496/determination-of-public-health-emergency. Published 7 February 2020. Accessed 16 June 2020.
4. US Food and Drug Administration. Medical devices and the COVID-19 pandemic. https://www.fda.gov/medical-devices/emergency-situations-medical-devices/medical-devices-and-covid-19-pandemic. Last updated 17 June 2020. Accessed 19 June 2020.
5. US Food and Drug Administration. Center for Devices and Radiological Health. Center for Biologic Evaluation and Research. Guidance for the content premarket submissions for software contained in medical devices.  Issued May 11, 2005
6. US Food and Drug Administration. Center for Devices and Radiological Health. Guidance for industry: Cybersecurity for networked medical devices containing off-the-shelf (OTS) software. https://www.fda.gov/media/72154/download. Issued 14 January 2005. Accessed 23 June 2020.
7. Dexcom press release. Dexcom continuous glucose monitoring systems to be temporarily offered to hospitals during COVID-19 emergency  https://www.dexcom.com/news/dexcom-cgm-hospital-covid19. Released 8 April 2020. Accessed 23 June 2020.

 
About the authors
Neeta Sharma, MS, is the vice president of global regulatory affairs at Dexcom. She oversees all regulatory affairs activities for Dexcom’s continuous glucose sensing technology. Sharma has more than 15 years of strategic and executive regulatory leadership experience at leading medical device companies, including DJO, Philips, Edward Lifesciences, and Medtronic, and across multiple fields, such as diabetes management and cardiovascular and orthopedic devices. She graduated from the University of Southern California with a dual master’s degree in biomedical engineering and regulatory sciences. Sharma can be contacted at neeta.sharma@dexcom.com.

Ginny Hu, PhD, is the manager of regulatory affairs at Dexcom, where she leads a team to provide regulatory strategy and filing support for Dexcom’s new market initiatives. Hu has more than 8 years of experience in the medical device industry, having had roles in research and development, marketing, and regulatory affairs leadership. She has a PhD in neurobiology from the University of Wisconsin, Madison, and is the author of numerous peer-reviewed research publications. Hu can be contacted at ginny.hu@dexcom.com.

Citation Sharma N, Hu G. Regulatory considerations for FDA enforcement policies during the COVID-19 public health emergency for medical device manufacturers. June 2020. Regulatory Focus. Regulatory Affairs Professionals Society.