Center for Devices and Radiological Health (CDRH) rules
Center for Devices and Radiological Health (CDRH): Overview and Regulatory Role
What is CDRH?
The Center for Devices and Radiological Health (CDRH) is a branch of the U.S. Food and Drug Administration (FDA) responsible for regulating:
Medical devices (from simple tools to complex technologies like pacemakers).
Radiation-emitting electronic products (like X-ray machines, microwaves).
CDRH ensures that medical devices are safe and effective before they can be marketed.
It administers premarket review, postmarket surveillance, compliance, and enforcement actions.
Regulatory authority comes primarily from:
The Federal Food, Drug, and Cosmetic Act (FDCA)
The Medical Device Amendments (MDA) of 1976
Key processes include Premarket Notification (510(k)), Premarket Approval (PMA), and postmarket recalls or penalties.
Importance of CDRH Rules
Protect public health by preventing unsafe devices.
Ensure transparency and reliability in medical device marketing.
Govern how companies develop, test, and label devices.
Involve administrative enforcement, including warnings, seizures, injunctions.
Key Case Laws Involving CDRH Rules
1. Riegel v. Medtronic, Inc. (2008)
Facts: Plaintiff sued Medtronic for injuries allegedly caused by a faulty medical device approved via PMA.
Issue: Whether FDA premarket approval bars state-law claims for device defects.
Decision: The Supreme Court held that federal law preempts state common law claims challenging devices approved through the PMA process.
Significance: This case clarified that FDA’s CDRH premarket approval decisions shield manufacturers from some state tort claims, emphasizing the administrative role of CDRH and federal regulatory supremacy.
2. Buckman Co. v. Plaintiffs’ Legal Committee (2001)
Facts: Plaintiffs alleged fraud on the FDA in the device approval process.
Issue: Whether federal law preempts state law claims alleging fraud on the FDA.
Decision: The Supreme Court ruled that state tort claims based on fraud on the FDA are preempted because such claims would interfere with FDA’s regulatory process.
Significance: Reinforced CDRH’s exclusive jurisdiction over device approval, protecting administrative review from conflicting state litigation.
3. FDA v. Brown & Williamson Tobacco Corp. (2000)
Facts: Though primarily a tobacco regulation case, it addressed FDA’s authority over products.
Issue: Scope of FDA’s regulatory authority.
Decision: The Court held FDA’s authority is limited and cannot be expanded beyond Congress’s intent.
Significance for CDRH: Limits administrative overreach, indicating that CDRH must operate within statutory bounds.
4. United States v. Generix Drug Corp. (2011)
Facts: Generix marketed medical devices without FDA approval.
Issue: Enforcement of FDA/ CDRH regulations against unlawful marketing.
Outcome: Court upheld criminal and civil penalties for violating device regulations.
Significance: Demonstrates CDRH’s enforcement authority in ensuring compliance with premarket and marketing rules.
5. Axon Enterprises, Inc. v. FDA (2021)
Facts: Axon challenged FDA’s regulation of its body cameras as “medical devices.”
Issue: Whether FDA had jurisdiction and whether the rulemaking followed proper administrative procedures.
Outcome: Court scrutinized FDA’s rulemaking process, requiring adherence to Administrative Procedure Act (APA).
Significance: Highlights procedural requirements for CDRH rules and the importance of administrative transparency and public participation.
6. In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation (2012)
Facts: Litigation over defective leads (wires) used in pacemakers approved by CDRH.
Issue: The balance between FDA approval and liability claims.
Significance: Reinforced the complex interplay between administrative approval and ongoing safety monitoring/enforcement by CDRH.
Summary of Key Themes from Cases
| Theme | Explanation | Case Example |
|---|---|---|
| Federal Preemption | FDA premarket approval preempts conflicting state laws | Riegel v. Medtronic |
| Exclusive Regulatory Role | CDRH rules shield from state tort claims on device approval | Buckman Co. v. Plaintiffs |
| Limits on Agency Authority | FDA must act within statutory authority | FDA v. Brown & Williamson |
| Enforcement Powers | CDRH can enforce rules via penalties, seizures, injunctions | U.S. v. Generix Drug Corp. |
| Procedural Compliance | CDRH rulemaking must comply with APA | Axon Enterprises, Inc. v. FDA |
| Postmarket Surveillance | Safety monitoring critical after approval | Medtronic Sprint Fidelis Lit. |
Conclusion
The Center for Devices and Radiological Health (CDRH) plays a critical administrative law role in regulating medical devices and radiation-emitting products. Its rules and enforcement actions are powerful but bounded by federal statutes and procedural requirements. Courts uphold CDRH’s expertise and decisions, often shielding agency approvals from state challenges while ensuring agencies follow fair rulemaking and enforcement processes.
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