Regulatory & Submissions · De Novo Support
De Novo Classification Request Support
The short answer
A De Novo asks FDA to create a classification, which means the submission has to propose the controls that will make the device type safe and effective. We help build the technical evidence and the special-controls argument, and we make sure your quality system can actually deliver what those controls will require.
Why this matters
- Special controls proposed in a De Novo become binding requirements for your device and for everyone who follows you. Proposing controls you cannot perform is a long-term compliance problem.
- Benefit-risk documentation must be traceable to real performance data and a maintained risk file.
- Testing strategy has no predicate to lean on, so the rationale for each test carries more weight.
Applicable regulations and standards
- 21 CFR Part 860 Subpart D
- De Novo classification process and content.
- ISO 14971
- Risk management supporting the benefit-risk determination.
- 21 CFR Part 820 / QMSR
- Design controls and records behind the performance claims.
What our consultants actually do
- Build the performance testing rationale where no predicate exists
- Draft the proposed special controls and assess whether your operation can sustain them
- Structure benefit-risk documentation traceable to the risk management file
- Write the device description, manufacturing and quality system content
- Reconcile design controls and verification/validation records before filing
- Draft responses to Agency questions during review
Across the product lifecycle
01 / DEVELOP
Design inputs and risk analysis written to support a novel classification.
02 / SCALE
Manufacturing controls defined alongside proposed special controls.
03 / TRANSFER
Design transfer records demonstrating reproducibility.
04 / VALIDATE
Verification and validation supporting each performance claim.
05 / MANUFACTURE
Routine production consistent with granted special controls.
06 / MAINTAIN
Ongoing conformance to special controls and post-market obligations.
Problems we are usually called about
- Special controls copied from an adjacent device type without feasibility assessment
- Performance claims not traceable to a specific test report
- Risk file that stops at design and never addresses production and post-production information
- Quality system unprepared for the post-market requirements the classification will impose
Typical deliverables
- Testing strategy and rationale document
- Proposed special controls with feasibility assessment
- Benefit-risk summary and risk file reconciliation
- Device description, manufacturing and quality system sections
Frequently asked
- Is a De Novo faster than a PMA?
- Usually, but the evidence burden is still substantial and there is no predicate to shorten the argument. The realistic comparison is against the cost of generating novel performance data, not against 510(k) timelines.
- Who writes the special controls?
- You propose them; FDA finalizes them. That is why proposing controls your quality system can consistently execute matters more than proposing the most conservative set.
References
More for regulatory & submissions
Technical, manufacturing and quality support for US FDA submissions — written by people who have reviewed and inspected against them.
- 510(k) SupportA 510(k) is an argument for substantial equivalence, supported by evidence your quality system has to be able to produce on demand.
- PMA SupportA PMA is reviewed alongside a pre-approval inspection of the manufacturing site, which means the manufacturing section is not paperwork — it is a description of a facility that will be examined.
- IND SupportFor an IND, the section that most often holds up a program is CMC.
- NDA SupportBy NDA, the manufacturing story has to be complete: a justified control strategy, validated process, qualified methods and a site that can demonstrate all of it during a pre-approval inspection.
- ANDA SupportGeneric applications are decided as much on manufacturing quality and data credibility as on bioequivalence.
- BLA SupportFor a biologic, the process is a substantial part of the product.
- IDE SupportAn IDE requires a description of how the investigational device is made and controlled, and design controls apply even though the device is not yet cleared.
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