FDA CDRH: Devices and Radiological Health Guide

The Center for Devices and Radiological Health (CDRH) is the product center within the United States Food and Drug Administration (FDA) responsible for ensuring that patients and healthcare providers have timely access to safe, effective, and high-quality medical devices and safe radiation-emitting electronic products. Operating under the U.S. Department of Health and Human Services (HHS), CDRH regulates the complete lifecycle of medical technologies—from early translational research and bench testing to premarket submission review, manufacturing compliance, and postmarket safety surveillance.

Notice: This guide provides administrative, legal, and regulatory information for biomedical researchers, academic technology transfer offices, and medical device sponsors. It does not provide individual clinical guidance or medical advice.

Researchers translating novel instrumentation from academic bioengineering laboratories should first review foundational concepts in what biomedical engineering is and statutory definitions of what constitutes a medical device before initiating formal interactions with CDRH.

What It Is and Who Runs It

CDRH is one of six specialized product centers across the FDA, operating from headquarters at the White Oak Federal Research Center in Silver Spring, Maryland. The center is led by the Office of the Center Director and administered across eight operational offices that oversee the total product lifecycle (TPLC):

• Office of Product Evaluation and Quality (OPEQ): Unifies premarket submission review (510(k), De Novo, PMA), compliance oversight, and postmarket surveillance across dedicated Office of Health Technology (OHT) therapeutic divisions.
• Office of Science and Engineering Laboratories (OSEL): Conducts laboratory research and regulatory science to evaluate emerging technologies, biomaterials, and test methodologies.
• Office of Strategic Partnerships and Technology Innovation (OST): Manages digital health initiatives, standard recognition, interoperability, and international regulatory convergence.
• Office of the Center Director: Formulates policy, oversees center-wide strategic priorities, and directs program coordination.
• Additional Core Offices: Includes the Office of Management, Office of Policy, Office of Communication, Information Disclosure, Training and Education, and the Office of Readiness and Response.

What Does CDRH Mean?

CDRH stands for the Center for Devices and Radiological Health. It carries a dual statutory mandate established under federal law: the medical device provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act, 21 CFR Parts 800–898) and the Electronic Product Radiation Control (EPRC) provisions (originally enacted under the Radiation Control for Health and Safety Act of 1968, 21 CFR Parts 1000–1050).

Eligibility (Summary and Official Authority)

Any individual, academic research institution, clinical investigator, domestic manufacturer, or foreign sponsor developing, testing, or marketing a medical device or radiation-emitting product intended for the United States commercial market falls under CDRH jurisdiction, as described on the official FDA program pages in November 2026.

• Medical Devices: Entities developing health technologies categorized under Class I (general controls), Class II (general and special controls, typically requiring 510(k) premarket notification), or Class III (general controls and premarket approval). Submissions must be formatted in compliance with the eSTAR template for 510(k) and De Novo pathways.
• Radiation-Emitting Electronic Products: Any manufacturer or assembler producing electronic equipment capable of emitting ionizing, non-ionizing, or ultrasonic radiation—including medical X-ray machines, diagnostic ultrasound, therapeutic lasers, and non-medical lasers.
• Investigational Device Exemption (IDE): Clinical investigators and sponsors conducting clinical studies involving significant-risk medical devices must secure CDRH approval prior to initiating human enrollment.

What It Funds or Requires

CDRH is a regulatory enforcement and evaluation body rather than a primary grant-awarding institution, though it operates regulatory science collaborations and supports user fee mechanisms under the Medical Device User Fee Amendments (MDUFA). Depending on product classification, CDRH mandates specific statutory deliverables:

• Quality System and Design Controls: Sponsors and manufacturers must establish and maintain design history files, risk management records, and manufacturing procedures aligned with 21 CFR Part 820 and design controls for medical devices.
• Premarket Clearance or Approval: Evidence demonstrating substantial equivalence to a legally marketed predicate device (510(k)), reasonable assurance of safety and effectiveness (PMA), or de novo classification for novel low-to-moderate risk devices.
• Radiation Safety Product Reports: Formal safety submissions under 21 CFR Part 1002 detailing engineering safeguards, interlocks, emission levels, and quality testing for radiation-emitting devices.
• Predetermined Change Control Plans (PCCP): Standardized protocols for artificial intelligence and machine learning (AI/ML) software functions.

What Is the PCCP Guidance for Medical Devices?

Under Section 515C of the FD&C Act, CDRH issued authoritative guidance entitled Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions. This mechanism allows developers of AI/ML-enabled software to incorporate planned postmarket algorithm modifications, retraining methodologies, and revalidation protocols directly into the initial premarket submission (510(k), De Novo, or PMA). When approved or cleared by CDRH, the sponsor can implement planned model updates within the defined scope without filing repeated supplemental marketing submissions.

Application or Compliance Steps

Researchers and medical device sponsors engage with CDRH through a defined sequence of regulatory milestones:

1. Device Classification Identification: Determine the statutory regulation number, product code, and risk class (Class I, II, or III) using CDRH classification databases or a formal 513(g) Request for Information.
2. Q-Submission / Pre-Submission Engagement: Request a voluntary Pre-Submission meeting with CDRH review staff to receive non-binding feedback on bench test protocols, animal models, human factor studies, or clinical trial designs.
3. eSTAR Submission Preparation: Assemble regulatory documentation using the mandatory electronic Submission Template And Resource (eSTAR) for 510(k) and De Novo dossiers.
4. CDRH Portal Submission: Upload the electronic package through the CDRH Portal / Customer Collaboration Portal (CCP) for automated technical screening and substantive review allocation.
5. Postmarket Registration and Listing: Following clearance or approval, facilities must register establishment records annually and list commercial devices via the FDA Unified Registration and Listing System (FURLS).

How to Get an FDA Accession Number

For radiation-emitting electronic products (such as medical lasers, laboratory UV illuminators, and X-ray systems), manufacturers must submit a required radiation product report under 21 CFR Part 1002:

1. Prepare the product report using the FDA eSubmitter software tool.
2. Submit the completed file electronically via the FDA Electronic Submissions Gateway (ESG).
3. CDRH processes the filing and issues an official Acknowledgement of Receipt Letter containing a unique 7-digit Accession Number.
4. Regulatory Note: An accession number serves exclusively as a tracking and filing acknowledgment confirming receipt into the CDRH database; it does not represent FDA marketing approval, clearance, or certification of report adequacy.

Typical Timeline Phases

CDRH regulatory reviews follow structured timeline phases defined by statutory mandates and MDUFA performance goals (prospective applicants should confirm current targets on official FDA pages):

• Phase 1: Acceptance Review (Days 1–15): Technical screening of incoming 510(k) or De Novo submissions to confirm administrative completeness.
• Phase 2: Substantive Review (Days 16–60): In-depth scientific evaluation by multidisciplinary teams comprising biomedical engineers, clinical specialists, statisticians, and toxicologists. CDRH may issue an Additional Information (AI) request, placing the review clock on hold while the sponsor addresses deficiencies.
• Phase 3: Decision Phase (Days 61–90+): Final administrative determination issuing an official clearance letter (510(k)), grant order (De Novo), or approval order (PMA).
• Pre-Submission Meetings: Scheduled typically within 70 to 75 calendar days of formal request receipt.

Common Mistakes

• Confusing Accession Numbers with Premarket Clearance: Marketing a medical laser or diagnostic system with only an EPRC accession number without obtaining required 510(k) clearance.
• Inappropriate Predicate Device Selection: Choosing an outdated, revoked, or technologically divergent predicate device in a 510(k) submission, leading to substantial equivalence rejection.
• Incomplete Design Control Traceability: Presenting prototype test data without documented design verification and validation records compliant with 21 CFR 820.30.
• Uncontrolled Software Modifications: Updating AI/ML algorithms post-clearance without an authorized Predetermined Change Control Plan (PCCP) or supplemental 510(k).
• Bypassing Pre-Submission Opportunities: Submitting complex or novel diagnostic technologies without prior Q-Submission alignment with CDRH review branches.

Related Programs and Oversight Bodies

Medical technologies and biomedical innovations intersect across multiple federal centers and international regulatory bodies:

Regulatory Agency / Program	Governing Entity	Jurisdictional Scope	Primary Submission Mechanism	Core Distinguishing Role
FDA CDRH	U.S. FDA / HHS	Medical devices and radiation-emitting electronic products	510(k), De Novo, PMA, IDE, eSTAR	Lead U.S. center for medical hardware, clinical software, and radiation safety.
FDA CDER	U.S. FDA / HHS	Small-molecule pharmaceuticals and therapeutic proteins	IND, NDA, ANDA	Evaluates chemical and biochemical drugs based on pharmacology.
FDA CBER	U.S. FDA / HHS	Biologics, cellular therapies, gene therapies, blood products	IND, BLA	Regulates biological therapeutics, viral vectors, and cellular implants.
EU MDR Notified Bodies	Designated European Conformity Assessment Bodies	Medical devices marketed in the European Union	CE Marking Conformity Dossier	Decentralized third-party audit and assessment system operating under EU 2017/745.

Frequently Asked Questions

What does CDRH mean?

CDRH stands for the Center for Devices and Radiological Health, the operational branch of the U.S. Food and Drug Administration responsible for regulating medical devices and radiation-emitting electronic products.

How can I contact FDA customer service?

Researchers and medical device sponsors contact customer service through the Office of Industry and Consumer Education (OICE), previously known as DICE. OICE answers technical and regulatory inquiries by email at [email protected] and via phone at (800) 638-2041 or (301) 796-7100. Email responses are typically provided within 48 business hours, excluding weekends and federal holidays.

What is the PCCP guidance for medical devices?

The Predetermined Change Control Plan (PCCP) guidance, authorized under Section 515C of the FD&C Act, provides recommendations for sponsors of artificial intelligence and machine learning-enabled medical devices. It allows planned model updates and revalidation protocols to be cleared in the initial submission, enabling software enhancements without filing repeated new 510(k) submissions.

How to get FDA accession number?

An FDA accession number is obtained by preparing a radiation safety product report using the FDA eSubmitter software and transmitting it through the FDA Electronic Submissions Gateway (ESG). CDRH processes the filing and issues an Acknowledgement of Receipt Letter containing the 7-digit accession number. Note that an accession number confirms filing receipt, not FDA clearance or approval.

What is CDRH Learn?

CDRH Learn is the FDA’s multimedia educational portal offering online training modules, recorded webinars, and slide presentations covering the total product lifecycle, premarket submissions, quality system regulation, and postmarket compliance.

Sources

• U.S. Food and Drug Administration. “Center for Devices and Radiological Health.” Official organization overview. Read November 8, 2026. https://www.fda.gov/about-fda/fda-organization/center-devices-and-radiological-health
• U.S. Food and Drug Administration. “CDRH Offices and Organization.” Official directory. Read November 8, 2026. https://www.fda.gov/about-fda/center-devices-and-radiological-health/cdrh-offices
• U.S. Food and Drug Administration. “Contact Us: Office of Industry and Consumer Education (OICE).” Official customer assistance portal. Read November 8, 2026. https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice
• U.S. Food and Drug Administration. “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions.” Guidance for Industry and FDA Staff. Read November 8, 2026. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial
• U.S. Food and Drug Administration. “CDRH Learn: Educational Resources.” Official educational catalog. Read November 8, 2026. https://www.fda.gov/training-and-continuing-education/cdrh-learn