How BioIntelScan scores risk.

The enforcement feed aggregates publicly available actions from FDA, FTC, CBER, OPDP, SEC, DOJ, and state attorneys general. Sources include:

• FDA Warning Letter database (CDER, CBER, CFSAN, CDRH).
• FTC press releases, complaints, consent orders, and case dockets.
• CBER guidance documents, Tissue Reference Group letters, and OTAT correspondence.
• OPDP untitled and warning letters concerning promotion.
• SEC litigation releases and 8-K filings referencing regulatory matters.
• DOJ injunctions and consent decrees referencing biologics or HCT/Ps.
• State attorney-general consent orders relating to stem cell, exosome, and regenerative medicine marketing.
• Curated industry reporting from BioPharma Dive, Endpoints News, FierceBiotech, and similar outlets, used to time-stamp events and link to primary sources.

Each item links to its primary source where available. We refresh the feed continuously and reprocess scores when new actions land.

The four prongs determine whether a human cells, tissues, or cellular and tissue-based product (HCT/P) qualifies for the streamlined Section 361 pathway, or whether it requires premarket approval as a biologic under Section 351:

1. Minimal Manipulation — processing does not alter the original relevant characteristics of the tissue.
2. Homologous Use — the indication uses the same basic function as the donor tissue.
3. No Combination — the HCT/P is not combined with another article (with limited exceptions).
4. No Systemic Effect / Not Dependent on Metabolic Activity — the product acts locally and does not rely on metabolic activity for its primary function (with limited exceptions).

The Four-Prong Scanner evaluates user-submitted text against each prong and returns one of three verdicts per prong:

Each scored company receives an Enforcement Risk Score from 0–100. Scores are computed from the company’s public enforcement history using a transparent rubric:

Scores are capped at 100. Risk tiers map to score ranges:

Scores are analytical estimates of public enforcement exposure. They are not predictions of future agency action and they are not investment recommendations. See Disclaimers.

Regenerative medicine guidance shifts. When CBER issues new guidance, when OPDP updates promotional standards, or when FTC closes a precedent-setting case, the prior body of marketing claims, scanner outputs, and risk scores can become stale overnight.

The Retroactive Framework Re-Run reapplies the latest framework to the historical record:

1. A guidance event triggers a new framework version.
2. All scoped historical claims and scans are queued for re-evaluation under the new framework.
3. Items whose verdict changes under the new framework are flagged for the customer.
4. Customers receive a digest summarizing what changed and where to act.

The Re-Run runs on the Terminal tier and Practice + Agency tier. Solo customers receive guidance change notifications without automatic re-run.

We are explicit about the limits of the methodology:

• The score reflects public enforcement signals only. Confidential inspection findings and ongoing investigations are not included until they become public.
• Scores cannot account for remedial actions a company has taken privately (CAPA closure, leadership changes, manufacturing remediation).
• Verdicts depend on the accuracy of the input text and the current state of guidance, which evolves.
• AI-generated outputs can be inaccurate or incomplete and must be reviewed by qualified counsel before any compliance decision.

If you believe a specific score, verdict, or feed entry is inaccurate, email info@biointelscan.com with the company, item, and supporting documentation. We aim to review within five business days.

BioRegenEx Medical Technology · Texas, USA