Cybersecurity questions appear often in additional information letters. The team reads each question for the concern behind it, decides whether analysis, labeling, a design change or new testing answers it, and revises the documents so they agree with each other. When FDA asks for testing that was not done, an outside pen test may have to be scheduled and finished inside the 180-day response window.
On the map: Answer cyber deficiencies. Per-component testing justification. Pen test on short notice.
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Answer cyber deficiencies with evidence engineering can produce this week. Agree with regulatory before arguing scope, because a new pen test can take longer than the response window.
Each question is traced to missing evidence, weak traceability, an uncontrolled risk or doubt about a design assumption. Unclear or subjective questions go to a clarification call early in the 180 days.
The team picks the smallest remediation that resolves the concern. Better analysis or labeling can answer a question about a controlled risk. Missing evidence usually needs a test. A broad redesign is not promised before the narrower options are ruled out.
When FDA asks why a component was not tested, the answer is either a test or a written justification. The justification rests on the attack surface, the exposure of the interface, the implementation language and the device risk. The justification has to match what the architecture documents say about that component.
The test itself takes one to two weeks, but vendors can have long lead times. The vendor is booked as soon as the letter arrives, the scope is fixed to the interfaces FDA named, and time is kept for a retest and the report.
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