Eligibility assessment
A documented go/no-go review against the Breakthrough Devices Program criteria and the planned marketing pathway.
Breakthrough Device Designation
Breakthrough Device Designation request in two weeks.
For devices addressing serious or irreversibly debilitating conditions, a well-supported designation request can provide earlier and more frequent FDA interaction.
Best suited to
Devices addressing life-threatening conditions
Products offering meaningful clinical improvement
Novel technologies with limited alternatives
Teams preparing a financing milestone
510(k), De Novo or PMA-bound devices
Sponsors ready to provide supporting evidence
Scope and deliverables
What the request includes.
The request must do more than describe novel technology. It must connect the condition, current standard of care, clinical benefit and statutory criteria.
Condition and unmet need
A clear account of disease severity, limitations of available alternatives and the patient problem the device addresses.
Clinical advantage
A structured argument for more effective diagnosis or treatment using available clinical, analytical and literature evidence.
Device and intended use
A precise description of the technology, users, population, workflow, indication and proposed regulatory pathway.
Supporting evidence file
Relevant literature, preliminary performance data, comparative evidence and a credible development and validation plan.
FDA designation request
Complete application drafting, internal quality review, client approval, eSTAR assembly where applicable and filing confirmation.
Delivery plan
Two-week schedule.
- 01
Eligibility gate
Review the condition, proposed indication, technology, alternatives, development stage and available supporting evidence.
- 02
Days 1–4 · Position
Confirm intended use and build the unmet-need, clinical-benefit and statutory-criteria strategy.
- 03
Days 5–8 · Draft
Write the device description, eligibility rationale, evidence narrative and proposed development plan.
- 04
Days 9–10 · File
Resolve consolidated comments, perform quality review, prepare attachments and submit the request to FDA.
Guarantee boundaries
What the commitment covers.
- The two-week commitment covers drafting, client finalisation and FDA filing—not FDA’s designation decision.
- The submission guarantee begins after eligibility acceptance and receipt of the agreed evidence and product information.
- FDA may request additional information and controls its own decision timeline.
- Approval protection, resubmission support and refund terms are defined in the signed statement of work.
What we need from your team
What keeps the schedule on track.
- →Provide a stable proposed indication and an accurate description of device operation.
- →Share preliminary performance data, literature, competitor information and clinical rationale.
- →Make clinical, regulatory and executive decision-makers available during the sprint.
- →Return one consolidated set of comments and final approval within the agreed daily schedule.
Regulations, standards and guidance considered
FD&C Act Section 515BFDA Breakthrough Devices ProgramFDA Q-Submission ProgramFDA 510(k)FDA De NovoFDA PMA
Frequently asked questions
Before we begin.
Does two weeks mean FDA grants the designation in two weeks?+
No. Predetics commits to preparing and filing the accepted request in two weeks. FDA separately reviews the request and controls the designation decision timeline.
Does Breakthrough designation guarantee market clearance?+
No. Designation provides programme benefits such as prioritised interaction, but the device must still satisfy all requirements for its eventual 510(k), De Novo or PMA.
What happens if the eligibility review is negative?+
We explain why the current case is weak and identify whether stronger evidence, a revised indication, STeP or the standard regulatory pathway is more appropriate.
Can the designation support fundraising?+
Companies may disclose a granted designation, subject to accurate communications. It can be a useful milestone, but it should never be presented as FDA clearance.