FDA De Novo Database: Search Guide & Records

The FDA De Novo database is the official public repository maintained by the U.S. Food and Drug Administration to catalog all medical devices that have been granted marketing authorization through the De Novo classification pathway. When biomedical engineers and medical researchers evaluate what is a medical device under United States law, novel technologies that lack an existing predicate device must navigate this pathway. Understanding how to query this database enables researchers, regulatory affairs specialists, and clinical innovators to benchmark novel device categories, retrieve public decision summaries, and identify valid predicates for future submissions.

What it is

The FDA De Novo database serves as the official registry for novel, low- to moderate-risk medical devices that have been granted marketing authorization under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR Part 860. Historically, devices without a legally marketed predicate were automatically designated as Class III, necessitating an extensive Premarket Approval (PMA) application. The FDA De Novo classification pathway provides an alternate, risk-based regulatory mechanism that reclassifies eligible novel devices into Class I or Class II.

When the FDA grants a De Novo request, it creates a new device classification regulation and a new three-letter product code. Consequently, the granted device becomes a legally marketed predicate that future applicants can reference in standard 510(k) premarket notifications. The database compiles all granted orders and links each record to its underlying regulatory framework.

Who runs it and what it covers (scope, size only if sourced)

The database is operated and maintained by the Center for Devices and Radiological Health (CDRH) in collaboration with the Center for Biologics Evaluation and Research (CBER) within the FDA. It is publicly hosted on the FDA AccessData web portal under CDRH databases, as described on the official page on 2026-11-07.

The scope of the database encompasses all medical devices that have successfully completed the De Novo evaluation process since the pathway was established by the Food and Drug Administration Modernization Act of 1997 (FDAMA) and streamlined under the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA). The database specifically includes:

De Novo Tracking Numbers: Unique identifiers prefixed with “DEN” (e.g., DEN######) assigned sequentially to classification requests.
Authorized Device Information: Trade names, commercial brand names, and the formal corporate identity of the granted requester.
Newly Established Regulations: The Title 21 Code of Federal Regulations (21 CFR) classification assigned to the novel device type (spanning Parts 862 through 892).
Product Codes: The newly created three-letter product code assigned by CDRH to categorize the device and its specific technological characteristics.
Decision Summaries: Detailed, publicly releasable scientific documents that outline the clinical, bench, software, and toxicological evidence supporting the grant order.
PCCP Status: Flags indicating whether the granted order authorizes a Predetermined Change Control Plan (PCCP), frequently utilized in machine-learning-enabled medical software.

Crucially, the database records only granted De Novo classification orders; requests that have been declined, withdrawn, or remain under active agency review are not published.

How to search or use it

The FDA AccessData interface allows users to perform targeted queries using specific regulatory parameters. To locate records, identify newly established predicates, and retrieve evaluation documents, users should follow these seven search steps:

Navigate to the AccessData Search Portal: Access the official CDRH De Novo database search screen at accessdata.fda.gov.
Select Primary Query Fields: Enter known search parameters into the query form. Available fields include De Novo Number, Device Name, Requester Name, Regulation Number, and Product Code.
Filter by Medical Specialty Review Panel: Narrow broad exploratory searches by selecting a specific advisory committee panel from the dropdown menu (e.g., Cardiovascular, Neurology, Orthopedic, or General Hospital).
Apply Date Range Constraints: Specify start and end dates under Decision Date to identify recently classified device categories or monitor pathway trends over time.
Execute Query and Review Table Results: Click the “Search” button to generate a tabular list displaying matching De Novo Numbers, Device Names, Requester Names, Regulation Numbers, and Decision Dates.
Inspect Individual Records: Click a De Novo Number link to open the full record page, which details the regulation description, device class (Class I or Class II), advisory committee, and review panel.
Download the De Novo Decision Summary: Follow the embedded link to the official Decision Summary PDF. This document provides the evidentiary benchmark—including required bench tests, animal models, clinical study designs, and special controls—necessary for assembling an eSTAR FDA submission template 510(k) De Novo file.

Strengths and limits

The FDA De Novo database is a critical intelligence tool for medical device research and development, though researchers must account for its distinct operational boundaries:

Strengths:
- Transparent Evidentiary Standards: The linked Decision Summaries provide unparalleled visibility into the preclinical testing, biocompatibility standards, and clinical endpoints that the FDA required for marketing authorization.
- Clear Predicate Identification: Allows prospective device innovators to confirm whether a novel technology has already established a regulatory foothold and what special controls govern it under FDA medical device regulations classification 510(k) PMA.
- Public Access: Fully searchable and freely accessible without registration, user fees, or login restrictions.
Limits:
- Granted Requests Only: The database does not publish information on pending, withdrawn, or declined De Novo submissions, preventing visibility into unsuccessful regulatory attempts.
- Redacted Commercial Information: Decision Summaries redact proprietary manufacturing specifics, trade secrets, and complete design history files.
- Lag in PDF Publishing: While decision orders are logged quickly upon grant, there can occasionally be a delay before the comprehensive written Decision Summary PDF is posted to the repository.

Alternatives (table)

Database / Tool	Operating Agency	Primary Regulatory Focus	Key Evidentiary Output
FDA De Novo Database	FDA CDRH / CBER	Novel Class I & II devices authorized under section 513(f)(2)	De Novo Decision Summary; newly created product codes and regulations
FDA 510(k) Database	FDA CDRH	Premarket notifications cleared based on substantial equivalence	510(k) summary statements and clearance letters; see FDA 510(k) data
PMA Database	FDA CDRH	High-risk Class III devices approved through Premarket Approval	Summary of Safety and Effectiveness Data (SSED); see PMA database
Product Classification Database	FDA CDRH	All established medical device product codes and CFR citations	Device class, regulation number, review panel, and applicable submission type

FAQ

What does a De Novo number represent in the database?

A De Novo number, formatted with the prefix “DEN” followed by six digits (e.g., DEN200001), is the unique administrative tracking identifier assigned by CDRH to a De Novo classification request from the date of receipt through marketing authorization.

Can a device found in the De Novo database be used as a 510(k) predicate?

Yes. Once a De Novo request is granted and listed in the database, the device is officially classified into Class I or Class II. It establishes a new regulation and product code, allowing subsequent manufacturers to cite that device as a predicate in a standard 510(k) premarket notification.

What is a De Novo Decision Summary?

A De Novo Decision Summary is an official FDA technical evaluation document linked within each granted database record. It outlines the clinical evidence, bench testing protocols, biocompatibility assessments, software verification, and special controls required to establish reasonable assurance of safety and effectiveness.

Sources

FDA CDRH, “Device Classification Under Section 513(f)(2) (De Novo) Database,” https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm (read 2026-11-07).
FDA CDRH, “De Novo Classification Request,” Premarket Submissions Guidance and Program Documentation, https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/de-novo-classification-request (read 2026-11-07).
Code of Federal Regulations, Title 21, Part 860, Subpart D, “De Novo Classification Process,” https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-860/subpart-D (read 2026-11-07).