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FDA's Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. In addition, CDRH regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions.
Essentially, medical devices are subject to the general controls of the Federal Food Drug & Cosmetic (FD&C) Act which are contained in the final procedural regulations in Title 21 Code of Federal Regulations (21CFR) Parts 800 - 1299
Medical devices are classified into Class I, II, and III. Regulatory control increases from Class I to Class III. The device classification regulation defines the regulatory requirements for a general device type. Most Class I devices are exempt from Premarket Notification 510(k) (with the exception of Reserved Devices); most Class II devices require Premarket Notification 510(k); and most Class III devices require Premarket Approval (PMA).
Premarket Notification 510(k) requires demonstration of Substantial Equivalence (SE) to legally marketed device in U.S. SE means “Substantial Equivalence” or “Just as Safe and Just as Effective”.
Premarket Approval (PMA) requires proof of reasonable assurance of safety and effectiveness.
An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. Clinical studies are most often conducted to support a PMA. Only a small percentage of 510(k)'s require clinical data to support the application.
Device manufacturers and importers of all devices:class III devices, and those class II devices that are permanently implantable, life supporting, or life sustaining; and class I and those class II devices that are not permanently implantable, life supporting, or life sustaining, must submit malfunction reports in full compliance with FDA's Medical Device Reporting regulation.
Recently-Approved Devices The products listed here include some of the newest medical technology available. For each product, you can find information about what the device is, how it works, when it can be used, and when it should not be used.
PMA Approvals : Monthly listings of all new or high-risk medical devices that were approved via the premarket approval (PMA) pathway. These devices require a more rigorous premarket review than the 510(k) pathway.
510(k) Clearances: Monthly listings of new devices that have been shown to be "substantially equivalent" to devices that are already marketed legally for the same use.
Humanitarian Device Exemptions (HDE): Listing of devices that have been approved to treat or diagnose a disease or condition that affects fewer than 4,000 individuals in the United States per year.
De novo Classification Orders: Listings of new devices for which a de novo has been granted.
Listings of de novo Classification Orders
CDRH Inspections Database Provides information about medical device inspections that were the responsibility of CDRH from 2008 to the present.
CFR Title 21 - Food and Drugs This database contains the most recent revision from the Government Printing Office (GPO) of the Code of Federal Regulations (CFR) Title 21 - Food and Drugs.
Clinical Laboratory Improvement Amendments (CLIA) This database contains the commercially marketed in vitro test systems categorized by the FDA since January 31, 2000, and tests categorized by the Centers for Disease Control and Prevention (CDC) prior to that date.
CLIA Currently Waived Analytes This database contains the commercially marketed in vitro test systems categorized as CLIA waived by the FDA since January 31, 2000, and by the Centers for Disease Control and Prevention (CDC) prior to that date. CLIA waived test systems are waived from certain CLIA laboratory requirements (42 CFR Part 493).
FDA Certified Mammography Facilities A searchable listing by state and zip code of all mammography facilities certified by the Food and Drug Administration (FDA) as meeting baseline quality standards for equipment, personnel and practices under the Mammography Quality Standards Act of 1992 (MQSA).
Humanitarian Device Exemption (HDE) Searchable listing of Humanitarian Device Exemption (HDE) Class III medical devices.
IVD Home Use Lab Tests (Over The Counter) Tests Searchable listing of Over-the-Counter tests (OTC) and collection kits that have been cleared or approved by the FDA.
MAUDE (Manufacturer and User Facility Device Experience Represents reports of adverse events involving medical devices. The data consists of all voluntary reports since June, 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August, 1996.
Recalls of Medical Devices This database contains a list of classified medical device recalls since November 1, 2002.
Registration & Listing This searchable database contains establishments (engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of medical devices intended for human use and commercial distribution) and listings of medical devices in commercial distribution by both domestic and foreign manufacturers. Note: This database is updated once a week.
Total Product Life Cycle (TPLC) The Total Product Life Cycle (TPLC) database integrates premarket and postmarket data about medical devices. It includes information pulled from CDRH databases including Premarket Approvals (PMA), Premarket Notifications (510[k]), Adverse Events, and Recalls. You can search the TPLC database by device name or procode to receive a full report about a particular product line.
FDA Recognized Consensus Standards This database consists of those national and international standards recognized by FDA which manufacturers can declare conformity to and is part of the information the Center can use to make an appropriate decision regarding the clearance or approval of a submission. Information submitted on conformance with such standards will have a direct bearing on safety and effectiveness determinations made during the review of IDEs, HDEs, PMAs, and PDPs. Conformance with recognized consensus standards in and of itself, however, may not always be a sufficient basis for regulatory decisions.
X-Ray Assembler Data Federal regulations require that an assembler who installs one or more certified components of a diagnostic x-ray system submit a report of assembly. This database contains the releasable information submitted including Equipment Location, General Information and Component Information. Note: Data does not include dental system installations.