Deficiency matrix
Every FDA comment mapped to its underlying concern, responsible owner, required evidence, dependencies and completion date.
FDA hold letter rescue
FDA Additional Information response support.
An Additional Information request pauses review, but it does not remove the deadline. We triage every deficiency, identify what is genuinely missing and build the shortest defensible route to a complete response.
Best suited to
510(k) Additional Information requests
Cybersecurity deficiencies
AI/ML performance questions
Software documentation gaps
Clinical evidence challenges
Teams facing a fixed response deadline
Scope and deliverables
What we review and prepare.
Good response strategy separates requests that need explanation, document correction, targeted testing or a broader product change.
Regulatory response strategy
A decision on where to agree, clarify, provide evidence, propose an alternative or request further FDA interaction.
Software remediation
Targeted requirements, architecture, traceability, anomaly, verification or lifecycle updates tied to specific findings.
Cybersecurity response
Threat-model, SBOM, architecture, testing, vulnerability and lifecycle evidence aligned to FDA’s questions.
AI/ML and clinical evidence
Dataset, ground-truth, subgroup, acceptance-criteria, standalone or clinical-study responses without unnecessary rework.
Response package
Revised documents, point-by-point responses, supporting attachments, consistency review and submission-ready assembly.
Delivery plan
Response schedule.
- 01
First 48 hours
Secure the hold letter, original submission, FDA history and key evidence; identify deadline, fatal risks and immediate owners.
- 02
Response architecture
Build the deficiency matrix, determine clarification versus remediation and sequence work around testing and dependencies.
- 03
Evidence and drafting
Run targeted workstreams in parallel, hold regular decision reviews and draft responses as evidence becomes available.
- 04
Challenge and submit
Conduct independent consistency review, resolve weak answers, finalise attachments and file before the official deadline.
Guarantee boundaries
What the commitment covers.
- FDA generally provides a limited response window stated in its correspondence; the sponsor remains responsible for tracking the official deadline.
- Predetics confirms the response schedule after reviewing the full letter, original submission and available evidence.
- No consultant can guarantee FDA acceptance where device performance or required evidence is inadequate.
- Any emergency-start, response-date or remediation commitment is documented in the signed statement of work.
What we need from your team
What keeps the schedule on track.
- →Provide the complete FDA letter, original submission, prior correspondence and current response drafts immediately.
- →Give Predetics direct access to the engineers, security owners, statisticians and clinicians responsible for evidence.
- →Escalate product and testing decisions quickly through one accountable programme lead.
- →Maintain an authoritative response tracker and submit within the official FDA deadline.
Regulations, standards and guidance considered
FDA 510(k)FDA Q-Submission ProgramIEC 62304ISO 14971FDA Cybersecurity GuidanceNIST SSDFIEC 62366-1IMDRF SaMD
Frequently asked questions
Before we begin.
Is an FDA hold letter the same as rejection?+
No. An Additional Information request pauses the review clock and asks the sponsor to resolve identified deficiencies within the stated response period.
Can every FDA request be challenged?+
No. Some findings identify real evidence gaps. We challenge or clarify only where the submitted evidence and regulatory basis support a defensible alternative.
Can you avoid repeating a clinical study?+
Sometimes existing data, analysis or a more precise explanation can answer the concern. We first test that route, but we do not promise to avoid new testing where FDA’s concern is valid.
How quickly can Predetics start?+
Start time depends on specialist availability and conflict checks. For urgent cases, share the letter and deadline first so we can assess the criticality and suitable team.