//FDA MEDICAL DEVICE CYBERSECURITY

Get Your FDA Cybersecurity Submission Right — First Time

FDA cybersecurity requirements for medical devices have never been more demanding. The June 2025 final guidance — ‘Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions’ — substantially raises the bar, making cybersecurity a standalone regulatory obligation that can, by itself, result in a Refuse to Accept (RTA) decision or denial of market authorisation.

Periculo provides specialist cybersecurity support to medical device manufacturers preparing FDA premarket submissions. We handle the cybersecurity workstream — risk management, documentation, SBOM, security architecture, and submission preparation — so your FDA submission contains the evidence reviewers expect. We don’t submit your device to the FDA or manage your regulatory affairs. We deliver the cybersecurity content and evidence your submission needs.

Why FDA Cybersecurity Compliance Is Critical

The June 2025 guidance replaces the 2023 version and finalises the March 2024 draft ‘Select Updates.’ Key changes include:

CYBERSECURITY IS NOW A STATUTORY REQUIREMENT

Section 524B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), enacted as part of the Food and Drug Omnibus Reform Act (FDORA) in December 2022, makes cybersecurity a legal obligation — not just guidance — for cyber devices. The June 2025 FDA final guidance provides the most detailed interpretation yet of how manufacturers must meet these obligations.

Failure to comply is now a prohibited act under Section 301(q) of the FD&C Act. Inadequate cybersecurity documentation can result in an RTA decision, meaning FDA will not even begin reviewing your submission.

THE ‘CYBER DEVICE’ DEFINITION IS BROADER THAN YOU MAY THINK

FDA’s current definition of a cyber device is broad: any device that contains software or is itself software falls within scope — whether or not it is network-enabled. This includes devices with wireless connectivity, USB interfaces, Bluetooth, cloud connections, and software-only medical devices (SaMD). If your device runs software, FDA cybersecurity requirements apply.

CYBERSECURITY CAN AFFECT SUBSTANTIAL EQUIVALENCE

For 510(k) submissions, FDA may determine that a subject device is not substantially equivalent to its predicate if the device has increased cybersecurity risks and insufficient evidence of security controls. Cybersecurity is no longer a separate consideration — it is part of the core safety and effectiveness determination.

FDA REGULATORY FRAMEWORK

OUR FDA CYBERSECURITY SERVICES

WHO WE WORK WITH

HOW IT WORKS

READY TO GET YOUR FDA CYBERSECURITY DOCUMENTATION RIGHT?

The FDA Regulatory Framework

What the FDA Actually Requires from Medical Device Manufacturers

The FDA's cybersecurity requirements for medical devices aren't optional, and they're no longer an afterthought. Under the Consolidated Appropriations Act 2023, any device manufacturer submitting a 510(k), De Novo, or PMA application must now demonstrate a credible, documented approach to cybersecurity — or face refusal to accept.

That means a Software Bill of Materials (SBOM), a coordinated vulnerability disclosure policy, a post-market monitoring plan, and evidence that security has been designed in from the start — not bolted on before submission.

The FDA has made clear it will reject submissions that don't meet these expectations. Most device manufacturers aren't ready. We help them get there.

THE 2025 FINAL GUIDANCE

The June 2025 guidance replaces the 2023 version and finalises the March 2024 draft ‘Select Updates.’ Key changes include:
Expanded and clarified definition of ‘cyber device’ — any device containing software is in scope
Addition of Section VII, providing detailed requirements specifically for cyber devices under Section 524B
Explicit reference to ANSI AAMI SW96 as a key recognised standard for cybersecurity risk management
Requirement for approximately 12 standardised cybersecurity documents submitted via the eSTAR process

OUR FDA CYBERSECURITY SERVICES

FDA Cybersecurity Support, End to End

We work with medical device manufacturers at every stage of the regulatory journey — from early-stage design reviews to submission-ready documentation.

Pre-submission Cybersecurity Gap Analysis

We assess your device against FDA cybersecurity guidance and identify exactly what's missing before you submit. No surprises, no rejections.

Threat Modelling & Risk Assessment

We produce FDA-aligned threat models that map realistic attack paths against your device architecture — meeting the specific expectations set out in the 2023 guidance.

SBOM Development & Management

We build and validate your Software Bill of Materials to the FDA's required standards, including third-party component visibility and known vulnerability mapping.

Cybersecurity Documentation Packages

We produce the full documentation set your submission needs — security architecture documentation, vulnerability management processes, and post-market monitoring plans that hold up to FDA scrutiny.

Coordinated Vulnerability Disclosure (CVD) Policy

We design and implement a disclosure policy that satisfies FDA requirements and protects your organisation if a vulnerability is reported post-market.

WHO WE WORK WITH

Built for Medical Device Manufacturers Who Can't Afford to Get This Wrong

We work with MedTech companies ranging from early-stage startups bringing their first device to market, to established manufacturers managing complex portfolios across multiple jurisdictions.

If you're preparing a US market submission and cybersecurity is the piece you're least confident about, that's exactly where we operate.

We're particularly well-placed for manufacturers who are simultaneously navigating EU MDR or UKCA requirements alongside FDA, and need a partner who understands the full regulatory picture, not just one corner of it.

We don't do generic compliance. We work with your engineers, your regulatory affairs team, and your submission timeline to produce documentation that's accurate, defensible, and built for approval.

HOW IT WORKS

1. Discovery Call

We start by understanding your device, your submission timeline, and where you currently stand on cybersecurity documentation. No forms, no discovery questionnaires — just a direct conversation with someone who knows the FDA guidance inside out.

2. Gap Assessment

We map your current position against FDA requirements and produce a clear, prioritised list of what needs to be done. You'll know exactly what's missing and what it will take to fix it.

3. Documentation & Remediation

We get to work. Depending on your needs, this means threat modelling, SBOM development, policy drafting, architecture review, or the full package. We work to your timeline, not ours.

4. Submission Support

We review your final submission documentation, flag any remaining risk, and make sure what goes to the FDA is as strong as it can be. If Q-Sub feedback comes back, we help you respond.

READY TO GET YOUR FDA CYBERSECURITY DOCUMENTATION RIGHT?

Book a Discovery Call

FDA rejections cost time you don't have and money you shouldn't be spending. Most of the manufacturers we speak to have left cybersecurity too late — and are scrambling to catch up.

If your submission window is approaching, start the conversation now.

FAQ’s

What is the difference between DCC and Cyber Essentials?

Conducting a thorough hazard analysis is crucial for ensuring the safety and compliance of medical devices. Hazard analysis identifies potential risks and evaluates their impact on patient safety and device performance. At Periculo, we offer expert hazard analysis services to help you systematically identify, assess, and mitigate risks throughout the product lifecycle. Our approach includes detailed risk assessments, failure mode and effects analysis (FMEA), and the development of robust mitigation strategies. With Periculo’s support, you can ensure that your medical devices meet regulatory standards, enhance patient safety, and maintain high levels of performance and reliability.

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