AVSACyber
AVSA Cyber provides FDA-aligned software documentation and cybersecurity packages for in vitro diagnostic devices (IVDs). From SBOM delivery in as little as 72 hours to complete premarket cybersecurity documentation, we help manufacturers meet the requirements of FDA's September 2023 Cybersecurity Guidance, Section 524B of the FD&C Act, and the Quality Management System Regulation (QMSR).
Modern in vitro diagnostic (IVD) devices are complex, interconnected systems. They may include cloud-connected analyzers, middleware interfaces to Laboratory Information Systems (LIS) and Electronic Health Records (EHR) platforms, mobile applications for result reporting, AI-enabled interpretation tools, and companion diagnostic software linked to therapeutic decisions. Every connection expands the attack surface and introduces cybersecurity risks that FDA reviewers increasingly expect manufacturers to identify, assess, and control.
AVSA Cyber specializes exclusively in the cybersecurity challenges unique to FDA-regulated IVDs. We help manufacturers secure every layer of the ecosystem — from embedded software and third-party components to cloud services and data interfaces — while aligning documentation with FDA expectations. The goal is simple: ensure that an assay's analytical and clinical performance is never compromised by a vulnerable dependency, an overlooked threat, or an incomplete cybersecurity submission.
By combining deep IVD expertise with FDA-focused cybersecurity practices, AVSA Cyber helps manufacturers build safer products, streamline regulatory reviews, and maintain compliance throughout the product life cycle.
FDA reviewers do not evaluate software and cybersecurity in isolation. Software documentation developed under IEC 62304 and cybersecurity documentation aligned with AAMI SW96 and FDA's September 2023 Cybersecurity Guidance are expected to work together as a cohesive body of evidence.
AVSA Cyber develops both software and cybersecurity deliverables as a single, integrated submission package. Requirements, architecture, risk analyses, threat models, SBOMs, verification activities, and cybersecurity controls are cross-referenced and internally consistent, reducing review questions and helping demonstrate a clear connection between software design, risk management, and cybersecurity assurance.
The result is a streamlined, FDA-ready submission package that supports efficient review while providing reasonable assurance that the device remains safe and effective in the face of evolving cybersecurity threats.
Many IVD sponsors focus on analytical and clinical study planning, only to discover late in the process that cybersecurity and software documentation are also critical components of a successful Investigational Device Exemption (IDE) submission.
For software-enabled or connected IVDs, FDA expects appropriate software documentation and a cybersecurity risk assessment as part of the IDE package. Gaps in these materials can lead to additional information requests, review delays, or, in some cases, a clinical hold that postpones the start of a pivotal study.
AVSA Cyber helps sponsors prepare FDA-ready IDE cybersecurity and software documentation, including cybersecurity risk assessments, threat modeling, architecture documentation, software lifecycle evidence, and supporting risk management records. By addressing these requirements early, manufacturers can reduce regulatory friction and keep clinical development programs on schedule.
Cybersecurity controls do not exist in isolation. Changes such as authentication requirements, encryption, software updates, network segmentation, or vulnerability patches can affect assay timing, instrument performance, system interoperability, and data flow throughout the IVD ecosystem.
AVSA Cyber works across cybersecurity, software, analytical validation, and clinical validation to ensure that security improvements do not create unintended impacts on device performance or regulatory evidence. We evaluate how cybersecurity controls interact with assay workflows, instrument operation, and clinical study data so that compliance efforts remain aligned with validation objectives.
The result is a coordinated approach that protects both security and performance — helping manufacturers avoid situations where a software update jeopardizes a limit of detection (LoD) study, disrupts a clinical validation program, or triggers costly re-validation activities that delay submission timelines. By integrating cybersecurity planning with validation strategy from the outset, we help keep development, testing, and regulatory milestones on track.
A complete Software Bill of Materials (SBOM) is often the foundation of an FDA cybersecurity submission — and one of the most time-consuming artifacts to produce. We generate CycloneDX or SPDX SBOMs with component identification, license analysis, vulnerability correlation, and VEX (Vulnerability Exploitability eXchange) mapping to distinguish exploitable risks from non-applicable findings. Send us your build, dependency information, or source repository access, and we deliver a submission-ready SBOM package formatted for direct inclusion in your eSTAR cybersecurity documentation — typically by the end of the week.
Section 524B of the FD&C Act elevated cybersecurity from a recommended practice to a regulatory requirement for devices that meet the definition of a cyber device. FDA reviewers increasingly scrutinize SBOMs, threat models, vulnerability management processes, and post-market cybersecurity plans as part of the submission process. The consequences of deficiencies are real: delayed clearances, extended review cycles, missed market opportunities, and increased development costs.
Deficient or incomplete cybersecurity documentation can prevent a submission from advancing to substantive review. Missing SBOMs, inadequate cybersecurity plans, or incomplete supporting documentation may trigger an RTA determination, requiring resubmission and extending timelines before meaningful FDA feedback is received.
Cybersecurity gaps frequently generate additional information requests and major deficiencies during review. An incomplete threat model, undocumented software dependency, overlooked interface risk, or insufficient vulnerability management process can result in months of remediation, documentation updates, and regulatory back-and-forth.
Cybersecurity failures are ultimately patient-safety risks. Unauthorized modification of data, compromised system functionality, or disruption of critical device operations can affect diagnostic results and clinical decision-making. FDA's cybersecurity requirements are designed to help ensure that device safety and effectiveness are maintained throughout the product life cycle.
Cybersecurity obligations do not end at clearance. Newly disclosed vulnerabilities, unpatched software components, or weaknesses in third-party dependencies can create regulatory, operational, and reputational risks. Without a mature vulnerability management and coordinated disclosure process, manufacturers may face corrective actions, Medical Device Reporting (MDR) obligations, field actions, or recalls.
AVSA Cyber helps manufacturers identify and address these risks before they become regulatory delays — building FDA-ready cybersecurity documentation that supports efficient review and long-term compliance.
We build the software and cybersecurity artifacts FDA reviewers expect — and align them with your analytical and clinical evidence so your submission tells a single, consistent story.
From rapid SBOM generation to complete premarket cybersecurity packages, IDE support, penetration testing, and post-market surveillance, AVSA Cyber helps manufacturers navigate the increasingly complex cybersecurity requirements for FDA-regulated in vitro diagnostic devices.
Submission-ready Software Bills of Materials (SBOMs) in CycloneDX or SPDX format, complete with Vulnerability Exploitability eXchange (VEX) analysis and documentation suitable for direct inclusion in your eSTAR submission.
Comprehensive cybersecurity documentation for 510(k), De Novo, and PMA submissions, aligned with FDA's September 2023 Cybersecurity Guidance and Section 524B requirements.
Many IVD sponsors discover too late that Investigational Device Exemption (IDE) submissions require software documentation and cybersecurity evidence as well. We help prevent the delays and clinical holds that can derail pivotal studies.
FDA reviewers expect manufacturers to understand how threats move through an IVD ecosystem. We develop threat models tailored to analyzer firmware, middleware, cloud services, LIS/EHR integrations, and mobile applications.
Independent security testing aligned with FDA expectations and IEC 81001-5-1 principles, covering connected IVD systems across devices, networks, applications, and APIs.
Cybersecurity controls can influence assay timing, instrument behavior, workflow performance, and data integrity. We coordinate cybersecurity activities with validation programs to avoid costly rework and study delays.
FDA cybersecurity obligations continue long after clearance. We help manufacturers establish sustainable post-market processes that support ongoing compliance and risk management.
Received an Additional Information (AI) request, deficiency letter, or cybersecurity-related review question? We help manufacturers close gaps quickly and respond with reviewer-focused evidence.
Build cybersecurity into your design controls before auditors and regulators ask for it. We help manufacturers align development practices with FDA expectations, QMSR requirements, and ISO 13485 quality systems.
AVSA Cyber has supported cybersecurity documentation across the full in vitro diagnostics landscape, including emerging Software-as-a-Medical Device (SaMD) and AI-enabled diagnostics, which are under increasing regulatory scrutiny.
PCR and NGS workflows with cloud-connected pipelines, bioinformatics processing, and distributed data environments.
Connected analyzers, readers, and instrument software with external reporting and middleware dependencies.
High-throughput bench analyzers integrated with laboratory information systems (LIS) and enterprise middleware.
Instrument-driven systems with real-time processing, data transfer, and LIS/EHR integration points.
Automated identification systems, MALDI-TOF platforms, and antimicrobial susceptibility testing software.
Drug-linked diagnostic systems where cybersecurity also protects clinical decision integrity and data traceability.
Mobile-enabled devices, BLE/Wi-Fi connectivity, and cloud-based result reporting used outside controlled lab environments.
Machine learning models, digital pathology systems, and algorithm-driven diagnostics with continuous update and data-dependency risks.
Every cybersecurity package we develop is structured around the same authoritative FDA regulations, guidance documents, and consensus standards that reviewers use to evaluate your submission. This ensures alignment from day one and reduces interpretive gaps during review.
Most modern IVDs are connected systems — linked to LIS platforms, cloud dashboards, middleware layers, mobile applications, or EHR systems. Under Section 524B of the FD&C Act, devices that meet the definition of a "cyber device" must include an SBOM, a vulnerability management plan, and reasonable assurance of cybersecurity in their submission.
FDA reviewers increasingly expect these elements to be complete at submission — missing or insufficient cybersecurity documentation can delay or prevent acceptance for review.
A Software Bill of Materials (SBOM) is a structured inventory of all software components in a device, including direct and transitive dependencies such as open-source libraries.
We can deliver SBOMs in as little as 72 hours because we use pre-validated pipelines and templates. You provide build artifacts or repository access, and we return a CycloneDX or SPDX SBOM, including license resolution, vulnerability mapping, and VEX annotations formatted for eSTAR submission.
Yes. This is a common gap in early submissions. FDA expects IDE applications for IVDs to include a software description, level of concern, and a cybersecurity risk assessment appropriate to the study environment and patient data exposure.
Missing or incomplete cybersecurity documentation can result in a clinical hold, delaying study initiation and downstream pivotal timelines.
Cybersecurity controls — such as encryption, authentication, patching, and network segmentation — can influence system behavior, including assay timing, data transfer pathways, and result interpretation workflows.
If these controls change after analytical or clinical validation is finalized, it may trigger the need for additional verification or even partial re-validation (e.g., LoD or method comparison studies). We align cybersecurity design with validation planning early, working with study teams to ensure changes do not invalidate existing evidence.
A complete package typically includes:
All components are aligned with FDA's 2023 Cybersecurity Guidance and AAMI SW96, and structured for submission readiness (including eSTAR formatting).
Ideally, at the architecture and design-definition stage — before interfaces, cloud connectivity, and update mechanisms are finalized. Early threat modeling is significantly more efficient than retrofitting controls after design freeze or failed testing.
That said, cybersecurity can be integrated at any stage. We routinely support programs at concept, mid-development, pre-submission, and post–FDA feedback stages, including remediation after deficiency letters or hold communications.
Reach out on Mobile/Text for an immediate response, or email us to scope your submission.