Regulatory & Quality
Clear FDA cybersecurity review the first time.
Benchmark before you file
Score your submission across every eSTAR category. Green means ready. Red means not. Fix your gaps now, not in a deficiency letter.
Mirrors the real eStar process
The readiness workflow follows the same evaluation your submission will actually go through, so nothing surprises you at review.
FDA judgment built in
Findings and guidance come from former FDA reviewers and standards authors: the people who know what a reviewer catches.
Questions before you file.
- What does FDA look for in a 510(k) cybersecurity review?
FDA expects cybersecurity documentation that traces your security requirements through the threat model, software components, security risks, risk controls, and verification testing. For simpler devices, some of these can be sections of a larger document rather than standalone deliverables. A typical package includes:
- Cybersecurity management plan
- Cybersecurity requirements
- Threat model
- Software bill of materials (SBOM), in machine-readable (CycloneDX or SPDX) and human-readable formats
- Security risk assessment
- Security risk management report, aligned with ISO 14971 and AAMI TIR57
- Cybersecurity controls report
- Security architecture views, including multi-patient harm, updateability and patchability, and secured use-case views
- Cybersecurity testing report covering vulnerability scanning, penetration testing, and fuzz testing, with supporting verification evidence
- Unresolved anomaly assessment
- Postmarket plan for monitoring and managing vulnerabilities
- Logging and forensic log instructions
- Security labeling and instructions for use
- Patching and update procedures
- Manufacturer Disclosure Statement for Medical Device Security (MDS2), often provided to hospitals
- Does Section 524B apply to my device?
Section 524B applies to cyber devices: devices that include software validated, installed, or authorized by the manufacturer, have the ability to connect to the internet, and could be vulnerable to cybersecurity threats. The test is whether the device is capable of connecting, not only whether its intended use involves connecting.
- What happens if my cybersecurity documentation is incomplete?
FDA now enforces completeness through eSTAR, which is required for 510(k) submissions. There is no separate cybersecurity refuse-to-accept review; eSTAR itself is the gatekeeper. Gaps found during substantive review lead to an additional-information request that puts the 510(k) on hold until you respond. Each extra round adds review time, so a complete first submission is usually the fastest path to clearance.
- How does Medcrypt help a 510(k) pass cybersecurity review?
Medcrypt benchmarks your submission evidence against FDA eSTAR categories before you file and flags gaps to address. Its guidance is informed by former FDA reviewers. Expert submission review is available as a separately scoped service. Medcrypt reports a 100% FDA submission approval rate for customers it has supported since October 2023.
- How long do I have to respond to an FDA cybersecurity deficiency letter?
For a 510(k) additional-information request, FDA's current policy generally allows 180 calendar days for a complete response. Medcrypt reports that customers using its deficiency-response support typically respond in 45 to 60 days.
AINN and hold letter response