Device status
Does the intended use make the product a device, and which software functions are inside the regulated boundary?
US FDA regulatory market
FDA pathways for medical device software.
We help software medical device teams turn intended use, classification, evidence, software documentation and quality-system requirements into a US submission plan.
Discuss your market plan →Pathways and services
Regulatory support for US FDA.
Premarket notification
FDA 510(k) submission
Predicate strategy, substantial-equivalence narrative, eSTAR assembly and review support.
View service →Novel deviceFDA De Novo request
Classification rationale, benefit-risk case, proposed special controls and evidence integration.
View service →EvidenceClinical evidence strategy
Evidence questions, literature, protocol inputs and clinical evaluation planning without claiming site operations.
View service →Use safetyHuman factors and usability
Use-related risk, interface evaluation and submission-ready documentation scaled to the device.
View service →LifecyclePost-market surveillance
Complaint, signal, reporting and change-assessment processes designed around actual product risk.
View service →Cross-functionalFDA regulatory consulting
Classification, Pre-Submissions, software documentation and deficiency support.
View service →What we need to determine
The decisions that shape your application.
Classification
Which regulation, product code and class fit the intended use and technological characteristics?
Submission route
Is there a suitable predicate for 510(k), or does novelty support a De Novo strategy or another pathway?
Evidence burden
What analytical, bench, software, human-factors and clinical evidence is necessary for this specific claim set?
How we work
From classification to market entry.
- 1
Characterize
Fix the intended use, indications, users, environment, architecture and device boundary.
- 2
Map
Assess classification, predicates, guidance, recognized standards and open regulatory questions.
- 3
Generate
Coordinate the evidence and controlled documentation needed for the selected pathway.
- 4
Submit and maintain
Assemble eSTAR, support review, then operationalize post-market and change obligations.
Core regulations, standards and guidance
FD&C Act21 CFR Parts 807 & 860FDA eSTARFDA QMSR / 21 CFR Part 820ISO 13485:2016ISO 14971IEC 62304IEC 62366-1
FAQ
Common questions about US FDA.
Regulatory classification and submission requirements depend on the final intended use, claims, technology and current FDA position. General page content is not a product-specific determination.
Does every medical device need a 510(k)?+
No. Requirements depend on classification and applicable exemptions. Some devices use De Novo, PMA or another route; some class I and class II devices are 510(k)-exempt but remain subject to other controls. The product code, regulation and limits of any exemption must be checked.
What changed when QMSR took effect?+
FDA’s QMSR became effective February 2, 2026 and incorporates ISO 13485:2016 by reference, with FDA-specific provisions and statutory definitions. ISO 13485 certification by itself does not establish full FDA compliance.
Should we request FDA feedback before submission?+
A Q-Submission can be useful when FDA input could materially alter classification, predicate choice, clinical design, human-factors validation or a novel technical approach. Feedback is generally nonbinding and depends on the questions and information submitted.
Can clearance be guaranteed?+
No. FDA makes the decision after reviewing the submission and may request additional information. A defensible strategy and complete evidence reduce avoidable uncertainty but cannot guarantee timing or outcome.