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 1. Home
 2. Regulatory Information
 3. Search for FDA Guidance Documents
 4. Cybersecurity in Medical Devices: Quality System Considerations and Content
    of Premarket Submissions

 1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT


CYBERSECURITY IN MEDICAL DEVICES: QUALITY SYSTEM CONSIDERATIONS AND CONTENT OF
PREMARKET SUBMISSIONS DRAFT GUIDANCE FOR INDUSTRY AND FOOD AND DRUG
ADMINISTRATION STAFF APRIL 2022

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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SUBMIT COMMENTS BY 07/07/2022

Submit Comments Online

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)),
to ensure that the FDA considers your comment on a draft guidance before it
begins work on the final version of the guidance, submit either online or
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If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number:
FDA-2021-D-1158

--------------------------------------------------------------------------------

Docket Number: FDA-2021-D-1158 Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

The need for effective cybersecurity to ensure medical device functionality and
safety has become more important with the increasing use of wireless, Internet-
and network- connected devices, portable media (e.g. USB or CD), and the
frequent electronic exchange of medical device-related health information. In
addition, cybersecurity threats to the healthcare sector have become more
frequent, more severe, and more clinically impactful. Cybersecurity incidents
have rendered medical devices and hospital networks inoperable, disrupting the
delivery of patient care across healthcare facilities in the US and globally.
Such cyberattacks and exploits can delay diagnoses and/or treatment and may lead
to patient harm.

This guidance is intended to provide recommendations to industry regarding
cybersecurity device design, labeling, and the documentation that FDA recommends
be included in premarket submissions for devices with cybersecurity risk. These
recommendations can facilitate an efficient premarket review process and help
ensure that marketed medical devices are sufficiently resilient to cybersecurity
threats.

Although FDA issued final guidance addressing premarket expectations in 2014 and
a draft guidance in 2018, the rapidly evolving landscape, and the increased
understanding of the threats and their potential mitigations, necessitates an
updated approach. The FDA has incorporated input from stakeholders at various
public meetings, comments from Docket FDA-2018-D-3443, and recommendations from
the Health Care Industry Cybersecurity (HCIC) Task Force Report to revise this
guidance to identify issues related to cybersecurity that manufacturers should
address in the design and development of their medical devices as well as in
preparing premarket submissions for those devices.


   CONTENT CURRENT AS OF:
   
   04/08/2022


 * REGULATED PRODUCT(S)
   
    * Medical Devices
   
   
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