Classification, Labeling, and FDA Pathways: Getting the Device Right Before It Ships
Before you ship, align three things: your classification logic, your labeling/claims discipline, and your FDA pathway strategy. Misalignment here drives rework and avoidable delays.
1) Classification drives everything downstream
Device classification affects controls, submission expectations, listing alignment, and post-market obligations. A classification approach should be documented and traceable to your intended use, technological characteristics, and claims.
What to define early
- Intended use and indications (claims boundaries)
- Likely product code/regulation alignment
- Comparable devices and competitive landscape
- Premarket submission pathway requirements
Common failure modes
- Listing data conflicts with classification assumptions
- Labeling contains claims that trigger a higher risk class
- Distributor marketing language changes regulatory posture
2) Labeling: Import readiness starts with claims
Labeling is not only packaging—it is your compliance signal. Consistency must be maintained across Instructions for Use (IFU), carton labels, website claims, and distributor materials to avoid being flagged for unapproved marketing.
3) Pathway alignment: 510(k) Strategy
If a 510(k) is required, your entry timeline and evidence plan depend on predicate selection and claims discipline. Even when a submission is not required, you should still validate the pathway logic so your registration/listing and import posture remains coherent.
How BRS LLC Aligns Strategy
We support manufacturers by aligning classification assumptions and labeling controls to the operational execution of listings.
- Classification Audits: We verify your product code and regulation alignment.
- Labeling Reviews: We ensure claims remain within your cleared intended use.
- Pathway Navigation: Strategic logic for Class I exempt vs. Class II 510(k) submissions.
- Submission Support: Bridging technical evidence with regulatory submission requirements.