When an emerging-pathogen response includes an applicable Section 564 public-health-emergency declaration, IVD manufacturers may need to coordinate clinical-performance evidence, analytical validation, quality documentation, software, and intended-use considerations. Before defining a hiring need, map the test, the evidence it needs, and the decisions that need accountable owners.
The FDA’s November 2026 guidance on validating certain in vitro diagnostic devices (IVDs) for emerging pathogens describes nonbinding recommendations during an applicable Section 564 declaration. It addresses information submitted in a pre-Emergency Use Authorization (pre-EUA), an EUA request, or for a test offered under an applicable enforcement-discretion policy. The guidance does not explain the EUA process. Employers should confirm requirements for their products and situation with qualified regulatory counsel.
Start with the intended test and setting
Before opening a search, define what the test is intended to detect, who will use it, where it will be used, and which specimen types, instruments, reagents, and software functions are involved. The FDA notes that the appropriate validation work can vary with the test technology, intended use, stage of an outbreak, and availability of validation materials.
That context helps employers avoid defining a role around a broad label such as “IVD expert.” One product may require deep molecular assay experience; another may depend more heavily on clinical-study operations, software validation, usability, or workflow integration. The job brief should describe the product and decisions the person will own.
Map clinical-performance evidence
Clinical-performance evaluation asks how accurately the test detects the analyte of interest in the intended population and setting. Employers can identify who will own the study plan, specimen strategy, site and operator coordination, data analysis, and documentation.
The FDA prefers natural clinical specimens. During an early outbreak, archived specimens may be a reasonable alternative when natural specimens are not readily available; contrived specimens may be acceptable when prospective and archived specimens are unavailable. FDA says an authorization for tests validated with contrived specimens would likely include a condition for post-authorization clinical-performance evaluation with natural patient specimens when feasible. These are recommendations for the scoped emergency-use context, not a universal study recipe.
A role map may include clinical-study operations, diagnostic or clinical science, biostatistics, and quality or regulatory contributors. The organization should specify which decisions belong to each role and how the team will manage changes in specimen availability or intended use.
Assign analytical validation ownership
Analytical validation addresses whether the test performs as intended across relevant test conditions. The FDA guidance discusses topics such as limit of detection, inclusivity, specimen stability, and additional testing in some circumstances.
For hiring, translate those work areas into capabilities rather than a long list of acronyms. Ask candidates to describe the types of assays and validation plans they have worked on, the methods and instruments involved, and how they documented results and deviations. Match qualifications to the specific test and scope; do not assume every IVD role requires the same background.
For a practical starting point when defining a medical-device quality engineer role, see HSG’s employer job-description template.
Include software, cybersecurity, and user workflow where relevant
If a test uses instrument or device software functions, the FDA recommends evaluating whether expected inputs produce appropriate outputs for intended functions and user needs, and assessing defects and risks. The guidance also discusses cybersecurity for instruments or software with external communications interfaces, and electromagnetic compatibility for electrically powered components.
Point-of-care, home-collection, and home-use tests can add usability, user-comprehension, and environmental-flexibility considerations. Employers should identify the intended operators and use environment, then define who owns usability evaluation, labeling comprehension, software workflow, and risk review. These responsibilities may be shared across engineering, quality, regulatory, human-factors, and clinical teams; the FDA does not prescribe a particular org chart.
Plan for controlled changes
The guidance says manufacturers seeking an EUA may consider a change protocol for potential future modifications. It describes a protocol as identifying anticipated changes, validation steps, success metrics, and related labeling changes. FDA uses “change protocol” here to distinguish this approach from predetermined change control plans (PCCPs) associated with marketing submissions. A protocol included in an initial EUA authorization can cover specified future modifications while keeping the device within its intended use.
For workforce planning, the practical question is who will evaluate a proposed change, maintain its evidence, coordinate validation, and ensure the relevant documentation and labeling stay aligned. Do not assume that every manufacturer needs a new position; first determine whether current owners have the authority and capacity to manage the work.
Turn the work map into a hiring brief
Once responsibilities are clear, define a role around its actual scope:
- Which test, specimen types, instruments, software, and use settings are included?
- Is the role accountable for clinical evidence, analytical validation, quality records, regulatory coordination, software, usability, or a defined combination?
- What decisions can the person make, and which teams must they coordinate with?
- Which experience is essential on day one, and which expertise can be supplied by existing colleagues or external advisors?
- What work samples or examples can show that a candidate has performed the relevant responsibilities?
A focused brief makes it easier to evaluate candidates against the work rather than searching for one person expected to cover every discipline. HSG supports permanent searches across medical-device quality, regulatory, engineering, manufacturing, and operations roles. Explore HSG’s Medical Device Quality & Regulatory recruiting practice.
If the capability gap centers on process transfer, production support, or equipment, HSG’s medical-device manufacturing engineer role-scope guide may help employers define that adjacent position separately.
This article is an employer workforce-planning resource, not legal, regulatory, or compliance advice. FDA guidance describes recommendations and does not establish job titles or a required organizational structure.
