Qualification and classification
SaMD status, likely FDA class, product code, reviewing division and the guidance and standards that apply.
FDA strategy and Pre-Sub
FDA strategy and Pre-Submission prepared in four weeks.
Before you lock the product or fund an expensive study, know the pathway, predicate options, claims, evidence requirements and questions that deserve FDA feedback.
Best suited to
Teams choosing between 510(k) and De Novo
AI/ML products planning validation studies
Devices with uncertain predicates
Founders preparing budgets or fundraising
Teams changing intended use or claims
Sponsors seeking FDA feedback before testing
Scope and deliverables
What you receive.
The strategy connects regulatory classification to product architecture, commercial claims and the evidence your submission must eventually support.
Pathway and predicate analysis
510(k), De Novo or other pathway assessment with predicate comparisons and substantial-equivalence risks.
Intended use and claims
Recommended indications, users, population, workflow and marketing boundaries that can be supported by evidence.
Evidence roadmap
Software, cybersecurity, usability, analytical and clinical-performance requirements with indicative acceptance criteria.
Regulatory risk register
The decisions most likely to delay or derail the submission, their impact and practical mitigation options.
FDA Pre-Sub package
Device description, background, proposed testing, focused questions, supporting appendices and eSTAR filing support.
Delivery plan
Four-week schedule.
- 01
Week 1 · Understand
Align intended use, workflow, architecture, claims, business priorities and the decisions the Pre-Sub must resolve.
- 02
Week 2 · Research
Determine product code, reviewing group, pathway, predicates, applicable guidance and likely evidence expectations.
- 03
Week 3 · Design
Develop the evidence roadmap, clinical and analytical testing strategy, acceptance criteria and focused FDA questions.
- 04
Week 4 · File
Complete client review, quality-check the Q-Submission package and submit it through the appropriate FDA channel.
Guarantee boundaries
What the commitment covers.
- The four-week commitment covers Predetics preparation and filing of the agreed Pre-Submission package, not FDA feedback.
- FDA generally controls a separate feedback timeline under the Q-Submission programme.
- The clock depends on complete product information, prompt workshops and client review within agreed turnaround times.
- Scope changes, new claims or unavailable evidence may require a revised timeline under the written engagement terms.
What we need from your team
What keeps the schedule on track.
- →Provide a stable intended use, product description, workflow and current architecture.
- →Make product, engineering, clinical and commercial decision-makers available for workshops.
- →Share existing predicate research, test data, protocols and prior FDA correspondence.
- →Return consolidated review comments and approvals within the agreed response window.
Regulations, standards and guidance considered
FDA Q-Submission ProgramFDA 510(k)FDA De Novo21 CFR 807IEC 62304ISO 14971IEC 62366-1FDA Cybersecurity Guidance
Frequently asked questions
Before we begin.
Does FDA reply within four weeks?+
No. Four weeks is the Predetics preparation and filing commitment. FDA operates its own Q-Submission feedback timeline, which begins after the package is accepted.
Do all software medical devices need a Pre-Sub?+
No. A Pre-Sub is most valuable when the cost of an unresolved regulatory, clinical, statistical or cybersecurity question is high. We recommend it selectively.
Can you prepare clinical and standalone test plans?+
Yes. Where appropriate, the strategy can include study design, endpoints, acceptance criteria, sample-size considerations and the questions to take to FDA.
Is an early prototype enough to begin?+
Often yes, provided the intended use, target users and basic device operation are stable enough for FDA to understand the proposed product.