FDA CDRH regulatory intelligence for biotech analysts.
Biotech analysts at small healthcare-focused funds need every FDA approval, every CRL, every advisory committee outcome — within minutes of publication, not days. A two-person investment team cannot afford a Clarivate Cortellis subscription at $15,000 per year per seat. Cresthaven Analytics delivers FDA CDER, CBER, CDRH, EMA, MHRA, and 75 other agencies as structured briefs from $149 per month.
What FDA CDRH does
The FDA Center for Devices and Radiological Health regulates medical devices, in vitro diagnostics, and radiation-emitting electronic products. CDRH publishes 510(k) clearances, De Novo authorizations, PMA approvals, software-as-medical-device guidance, AI/ML model expectations, cybersecurity requirements for connected devices, post-market surveillance orders, and recalls. The center has shifted aggressively toward digital health and AI-enabled device guidance, making it a central regulator for medtech operators and any analyst tracking medical-device innovation.
Why biotech analysts need FDA CDRH intelligence
For biotech analysts tracking medical-device companies, in-vitro diagnostics platforms, and AI/ML-enabled health technologies, FDA CDRH is the regulator that turns engineering into market access. 510(k) clearances, De Novo authorizations, PMA approvals, and the rapidly evolving SaMD and AI/ML model guidance directly determine which device companies can sell and which cannot. The center has shifted aggressively toward digital health and AI-enabled device regulation, making CDRH coverage essential for any analyst with medtech or digital-health exposure.
Recent FDA CDRH brief from Cresthaven
April 3, 2026 · 11:45 UTC
FDA CDRH issues final guidance establishing cybersecurity requirements for premarket submissions of connected medical devices
The FDA's Center for Devices and Radiological Health has published final guidance titled "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions," establishing comprehensive cybersecurity documentation requirements for premarket submissions (510(k), De Novo, PMA) of medical devices with network connectivity, wireless capability, or software-enabled functions. The guidance implements the cybersecurity authorities granted to FDA under Section 524B of the FD&C Act, as added by the Consolidated Appropriations Act of 2023.
Read the full brief →Recommended tier for biotech analysts
Executive ($999/month)
Up to 30 agencies covers the full healthcare regulatory universe (all three FDA centers, EMA, MHRA, EU SANTE, PMDA, TGA, HSA, plus CMS for reimbursement) with priority alerts for material developments. For an analyst at a smaller fund, Professional at $399/month covers 6 agencies — pick the three FDA centers plus EMA, MHRA, CMS.
View all tiers →Frequently asked
Does Cresthaven cover CDRH 510(k) clearances, De Novo, and PMA actions?
Yes. The FDA Medical Devices vertical covers 510(k) clearances, De Novo authorizations, PMA approvals, Q-Sub feedback summaries (where publicly disclosed), advisory committee outcomes, post-market surveillance orders, and recalls. Material first-of-kind clearances and PMAs receive high-materiality classification.
How does Cresthaven cover CDRH AI/ML and Software-as-Medical-Device guidance?
AI/ML guidance, the SaMD pre-cert program, predetermined change control plans (PCCP), and cybersecurity expectations for connected devices are all covered. As CDRH evolves its AI/ML regulatory framework, briefs flag both guidance-document publications and the first individual device authorizations that operationalize the new pathways.
Does Cresthaven cover medical device recalls and post-market safety actions?
Yes. Class I and Class II recalls, post-approval study orders, MDR enforcement, and Warning Letters are all covered. The materiality triage distinguishes routine corrective actions from product withdrawals and class-wide safety actions that affect investor models.
What is the recommended tier for a biotech fund covering CDRH alongside drug regulators?
Professional at $399 per month is the natural fit — six agencies covers FDA CDER + CBER + CDRH for full FDA exposure plus EMA + MHRA + CMS for cross-jurisdictional and reimbursement context. For broader sector coverage, Executive at $999 per month covers up to 30 agencies including all global biotech regulators with priority real-time alerts.