
[Federal Register Volume 81, Number 249 (Wednesday, December 28, 2016)]
[Notices]
[Pages 95617-95618]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31406]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-5105]


Postmarket Management of Cybersecurity in Medical Devices; 
Guidance for Industry and Food and Drug Administration; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the guidance entitled ``Postmarket Management of 
Cybersecurity in Medical Devices.'' FDA is issuing this guidance to 
inform industry and FDA staff of the Agency's recommendations for 
managing postmarket cybersecurity vulnerabilities for marketed medical 
devices. The guidance clarifies FDA's postmarket recommendations with 
regards to addressing cybersecurity vulnerabilities and emphasizes that 
manufacturers should monitor, identify, and address cybersecurity 
vulnerabilities and exploits as part of the postmarket management of 
their medical devices.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-D-5105 for ``Postmarket Management of Cybersecurity in Medical 
Devices.'' Received comments will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at http://www.regulations.gov or at the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    An electronic copy of the guidance document is available for 
download from the Internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the guidance document entitled 
``Postmarket Management of Cybersecurity in Medical Devices'' to the 
Office of the Center Director, Guidance and Policy Development, Center 
for Devices and Radiological Health, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-
0002 or the Office of Communication, Outreach, and Development, Center 
for Biologics Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist that office in 
processing your request.

FOR FURTHER INFORMATION CONTACT: Suzanne Schwartz, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5434, Silver Spring, MD 20993-0002, 301-
796-6937 or Stephen Ripley, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    On February 19, 2013, the President issued Executive Order 13636--
Improving Critical Infrastructure Cybersecurity, which recognized that 
resilient infrastructure is essential to preserving national security, 
economic stability, and public health and safety in the United States. 
Executive Order 13636 states that cyber threats to national security 
are among the most serious and that stakeholders must enhance the 
cybersecurity and resilience of critical infrastructure. This includes 
the Healthcare and Public Health Critical Infrastructure Sector.

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Furthermore, Presidential Policy Directive 21--Critical Infrastructure 
Security and Resilience (PPD-21) issued on February 12, 2013 tasks 
Federal Government entities to strengthen the security and resilience 
of critical infrastructure against physical and cyber threats such that 
these efforts reduce vulnerabilities, minimize consequences, and 
identify and disrupt threats. PPD-21 encourages all public and private 
stakeholders to share responsibility in achieving these outcomes.
    In recognition of the shared responsibility for cybersecurity, the 
security industry has established resources including standards, 
guidelines, best practices and frameworks for stakeholders to adopt a 
culture of cybersecurity risk management. Best practices include 
collaboratively assessing cybersecurity intelligence information for 
risks to device functionality and clinical risk. FDA believes that, in 
alignment with Executive Order 13636 and PPD-21, public and private 
stakeholders should collaborate to leverage available resources and 
tools to establish a common understanding that assesses risks for 
identified vulnerabilities in medical devices among the information 
technology community, healthcare delivery organizations, the clinical 
user community, and the medical device community. These collaborations 
can lead to the consistent assessment and mitigation of cybersecurity 
threats, and their impact on medical device safety and effectiveness, 
ultimately reducing potential risk of patient harm.
    Part 806 (21 CFR part 806) requires device manufacturers or 
importers to report promptly to FDA certain actions concerning device 
corrections and removals. However, the majority of actions taken by 
manufacturers to address cybersecurity vulnerabilities and exploits, 
referred to as ``cybersecurity routine updates and patches,'' are 
generally considered to be a type of device enhancement for which the 
FDA does not require advance notification or reporting under part 806. 
For a small subset of actions taken by manufacturers to correct device 
cybersecurity vulnerabilities and exploits that may pose a risk to 
health, the FDA would require medical device manufacturers to notify 
the Agency.
    This guidance clarifies changes to devices to be considered 
cybersecurity routine updates and patches (e.g., certain actions to 
maintain a controlled risk to health). In addition, the guidance 
outlines circumstances in which FDA does not intend to enforce 
reporting requirements under part 806 for specific vulnerabilities with 
uncontrolled risk. Specifically, FDA does not intend to enforce the 
reporting requirements when circumstances outlined in the guidance are 
met within the predefined periods of time (e.g., communicate 
vulnerability to customers and user community and propose a timeline 
for remediation within 30 days after learning of the vulnerability; fix 
the vulnerability and validate the change within 60 days after learning 
of the vulnerability; actively participate in an Information Sharing 
Analysis Organization (ISAO)). The Agency considers voluntary 
participation in an Information ISAO a critical component of a medical 
device manufacturer's comprehensive proactive approach to management of 
postmarket cybersecurity threats and vulnerabilities and a significant 
step towards assuring the ongoing safety and effectiveness of marketed 
medical devices.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Postmarket Management of Cybersecurity in 
Medical Devices.'' It does not establish any rights for any person and 
is not binding on FDA or the public. You can use an alternative 
approach if it satisfies the requirements of the applicable statutes 
and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
downloading an electronic copy from the Internet. A search capability 
for all Center for Devices and Radiological Health guidance documents 
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. Persons unable to 
download an electronic copy of ``Postmarket Management of Cybersecurity 
in Medical Devices'' may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. 
Please use the document number 1400044 to identify the guidance you are 
requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 803 (medical device 
reporting) have been approved under OMB control number 0910-0437; the 
collections of information in 21 CFR part 806 (reports of corrections 
and removals) have been approved under OMB control number 0910-0359; 
the collections of information in 21 CFR part 807, subpart E (premarket 
notification) have been approved under OMB control number 0910-0120; 
the collections of information in 21 CFR part 810 (medical device 
recall authority) have been approved under OMB control number 0910-
0432; the collections of information in 21 CFR part 814 (premarket 
approval) have been approved under OMB control number 0910-0231; the 
collections of information in 21 CFR part 820 (quality system 
regulations) have been approved under OMB control number 0910-0073; and 
the collections of information in 21 CFR part 822 (postmarket 
surveillance of medical devices) have been approved under OMB control 
number 0910-0449.

    Dated: December 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31406 Filed 12-27-16; 8:45 am]
 BILLING CODE 4164-01-P


