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| Clinical Laboratory Improvement Amendments |
FDA categories of commercially marketed in vitro diagnostic tests based on complexity and their potential risk to public health |
| Compliance activities | Activities involving the review, monitoring, evaluation, and surveillance of the regulated medical device industry |
| Device evaluation information |
Activities involving the evaluation of medical devices and clearance of devicesfor clinical trials and marketing. Programs include premarket approval, product development protocol, humanitarian device exemption, investigational device exemption, and premarket notification |
| FDA Modernization Act | Law signed on November 21, 1997 to streamline the process of bringing safe and effective drugs, medical devices, and other therapies to the U.S. market |
| Good manufacturing practice |
Guidance to ensure that manufacturers' and distributors' products consistently meet applicable requirements and specifications |
| Human Factors | Guidance for the design and labeling of medical devices, including human factor considerations, to reduce hazards associated with device use |
| In Vitro Diagnostic Devices | Source of comprehensive and integrated regulatory oversight for in vitro
diagnostic devices (IVDs). Also includes information to assist stakeholders
in understanding and obtaining the knowledge they need to make informed
decisions about the use of IVDs. |
| Medical Device User Fee and Modernization Act of 2002 | The Medical Device User Fee and Modernization Act of 2002 (MDUFMA), P.L. 107-250, amends the Federal Food, Drug, and Cosmetic Act to provide FDA important new responsibilities, resources, and challenges including user fees for premarket reviews, establishment inspections may be conducted by accredited persons (third-parties), and new regulatory requirements for reprocessed single-use devices |
| Postmarket surveillance | Activities related to the period after a medical device is cleared for
marketing including analysis of adverse event reports, recalls or other
corrective actions |
| Registration and listing | Disclosure requirements for domestic establishments engaged in the manufacture or other aspects of preparing medical devices intended for human use, and for domestic and foreign manufacturers whose devices are in commercial distribution |
| Reuse of single-use devices |
Policies related to the reprocessing and reusing of single use devices |
Updated 02/12/03
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