ChangeHawk monitors FDA, SEC, GDPR, healthcare, and industry-specific regulatory pages — and sends AI-powered alerts the moment rules change. Know what changed, what it means for your compliance posture, and what action to take.
This is what a ChangeHawk alert looks like when a regulatory page updates — not "something changed" but exactly what changed and what it means.
FDA updated its 510(k) pre-submission guidance to require additional cybersecurity documentation for connected medical devices. The new requirements mandate a Software Bill of Materials (SBOM) and a threat modeling assessment for any device with wireless connectivity — effective for submissions after March 1. If your device has Bluetooth or Wi-Fi connectivity, your next submission will require these two new documents. Legal review recommended before your next pre-submission meeting.
Regulators don't send you a calendar invite when rules change. FDA, SEC, and GDPR updates post to government websites — often quietly, between major announcements. Most compliance teams find out about changes from industry newsletters or external counsel, weeks after they go live. By then, your next submission, filing, or audit is already at risk. Automated monitoring closes that gap before it becomes a fine.
Compliance officers, legal teams, and risk managers across four high-stakes sectors use ChangeHawk to catch regulatory changes before their next audit, submission, or filing.
FDA • CMS • ONC • DEA
FDA guidance documents, 510(k) policies, drug approval requirements, and CMS reimbursement rules change frequently — and missing an update can delay or invalidate a submission. Monitor the exact pages that govern your product categories and know within hours when guidance shifts.
SEC • FINRA • FDIC • OCC • CFPB
SEC rule amendments, FINRA regulatory notices, and CFPB guidance updates directly affect reporting, disclosure, and product requirements. Monitor the exact SEC rulemaking pages relevant to your business — equities, derivatives, investment advisory, or consumer finance.
GDPR • CCPA • FTC • State AGs
Privacy law is one of the fastest-moving regulatory areas in the world. GDPR guidance from data protection authorities, CCPA amendments, and FTC enforcement updates can change what your privacy policy and data practices must say. Track the regulators your clients ask about most.
FDA • EMA • ICH • DEA
Drug approval pathways, clinical trial requirements, labeling standards, and controlled substance scheduling change through FDA and EMA guidance — often with 60–90 day implementation windows. Monitor the guidance pages relevant to your therapeutic areas and catch updates before they affect your NDA or IND submissions.
Not every government webpage update is a compliance event. ChangeHawk's AI filters signal from noise — escalating material changes and ignoring navigation tweaks.
Draft and final FDA guidance, SEC interpretive releases, and agency FAQ updates that clarify how rules apply to your specific situation — often more immediately actionable than the rule itself.
Federal Register notices, SEC proposed rules, and CFPB rulemaking proceedings. Know when comment periods open and close, and when final rules are published — before they hit your inbox as forward from outside counsel.
SEC enforcement press releases, FTC consent orders, and FINRA disciplinary actions signal where regulators are focusing. Patterns in enforcement tell you where to tighten controls before the next examination cycle.
Changes to forms, schedules, disclosure deadlines, and data formats — like SEC EDGAR updates, CMS quality reporting changes, or CDER submission format revisions — that affect your operational compliance calendar.
EMA guidance for EU clinical trials, GDPR decisions from national data protection authorities, MiFID II technical standards, and other cross-border regulatory updates that affect global operations.
Compliance deadlines get pushed, phased, or accelerated with less fanfare than the original rule. ChangeHawk catches implementation timeline updates on the same pages where rules are posted — before your compliance calendar falls out of sync.
Most compliance teams are still doing this manually. Here's how ChangeHawk replaces a broken process with a reliable one.
Paste the exact government or regulatory body pages into ChangeHawk — FDA guidance pages, SEC rulemaking indexes, GDPR authority opinion pages, state-specific compliance pages. Add as many as your plan allows. No integration required, no API keys, no IT ticket.
Pages are checked as frequently as hourly. ChangeHawk captures the page content, compares it to the previous version, and identifies any material differences — new text, removed requirements, updated dates, added documents, changed links.
When a change is detected, our AI reads the diff in context and writes a plain-English summary: what specifically changed, why it's likely significant, and what type of compliance action it typically requires. Not "15 characters changed on line 847" — but "FDA added a new requirement for cybersecurity documentation in 510(k) submissions."
The alert lands in your inbox (or your team's shared compliance inbox) with the AI summary, a direct link to the changed page, and a severity rating. Forward it to legal, log it in your compliance system, or schedule a review — the alert gives you enough context to act without reading the full regulatory document first.
Every change is logged: what was on the page before, what it says now, when the change was detected, and what the AI analysis said. When your next audit or inspection asks "how do you track regulatory changes," you can show them a timestamped log of every detection — not a spreadsheet someone updates manually.
Most compliance teams monitor 10–50 regulatory sources. Manually, that's 4–20 hours per week of high-cost staff time. Here's how the math breaks down.
ChangeHawk costs less per month than 30 minutes of outside counsel time — and it monitors your regulatory pages 24 hours a day.
Add your first 3 regulatory pages free. No credit card, no setup call.
Start monitoring the regulatory pages that matter to your compliance team. Free plan, no setup, no credit card. Add your first pages in under 2 minutes.