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* Skip to main content * Skip to FDA Search * Skip to in this section menu * Skip to footer links An official website of the United States government Here’s how you know The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site. The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. U.S. FOOD AND DRUG ADMINISTRATION * Search * Menu Search FDA Submit search FEATURED * Contact FDA * FDA Guidance Documents * Recalls, Market Withdrawals and Safety Alerts * Press Announcements * Warning Letters * Advisory Committees * En Español PRODUCTS * Food * Drugs * Medical Devices * Radiation-Emitting Products * Vaccines, Blood, and Biologics * Animal and Veterinary * Cosmetics * Tobacco Products TOPICS * About FDA * Combination Products * Regulatory Information * Safety * Emergency Preparedness * International Programs * News and Events * Training and Continuing Education * Inspections and Compliance * Science and Research INFORMATION FOR * Consumers * Patients * Industry * Health Professionals * Federal, State and Local Officials In this section: Search for FDA Guidance Documents * Search for FDA Guidance Documents * Search General and Cross-Cutting Topics Guidance Documents * Advisory Committee Guidance Documents * Clinical Trials Guidance Documents * Combination Products Guidance Documents * Import and Export Guidance Documents * Cross-cutting Guidance Documents 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GUIDANCE DOCUMENT CYBERSECURITY IN MEDICAL DEVICES: QUALITY SYSTEM CONSIDERATIONS AND CONTENT OF PREMARKET SUBMISSIONS DRAFT GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF APRIL 2022 Download the Draft Guidance Document Read the Federal Register Notice Draft Not for implementation.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 This guidance is being distributed for comment purposes only. * Share * Tweet * Linkedin * Email * Print 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can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date. 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 TOPIC(S) * 510(k) * Premarket Approval (PMA) * HUD/HDE * Investigational Device Exemption (IDE) Search for FDA Guidance Documents * Search for FDA Guidance Documents * Search General and Cross-Cutting Topics Guidance Documents * Advisory Committee Guidance Documents * Clinical Trials Guidance Documents * Combination Products Guidance Documents * Import and Export Guidance Documents * Cross-cutting Guidance Documents FOOTER LINKS * FDA Archive * About FDA * Accessibility * Visitor Information * Website Policies / Privacy * No FEAR Act * FOIA * HHS.gov * USA.gov Contact FDA Follow FDA on Facebook Follow FDA on Twitter View FDA videos on YouTube Subscribe to FDA RSS feeds FDA Homepage Contact Number 1-888-INFO-FDA (1-888-463-6332) Back to Top