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Results for “Device Approval”

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At least 955 records · Page 53Linked to original sources
PubMedDate not supplied

More than standards and regulations are needed to provide safe and effective devices.

Medical devices that met standards have been recalled. Quality systems that were said by internal audits to be in compliance with FDA regulations or ISO quality standards received serious questions after external auditing. Devices meeting standards or produced by quality systems felt to be in compliance have put patients at risk by failing at critical moments. Something more than just meeting standards and regulations is needed to provide safe and effective medical devices.

Device Approval↗
PubMedDate not supplied

New heart device cleared.

Explore the source record for details and available documents.

Cardiac Surgical Procedures↗
PubMed2001

Medical Device; exemption from premarket notification; class II devices; pharmacy compounding systems. Final rule.

The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for pharmacy compounding systems classified within the intravascular administration set, with certain limitations. This rule will exempt from pre market notification pharmacy compounding systems classified within the intravascular administration set and establishes a guidance document as a special control for this device. FDA is publishing this order in accordance with the Food and Drug Administration Modernization Act of 1997 (FDAMA).

Device Approval↗
PubMed2001

Orthopedic devices: classification and reclassification of pedicle screw spinal systems; technical amendment. Final rule; technical amendment.

The Food and Drug Administration (FDA) is correcting a final rule that classified certain previously unclassified pre amendments pedicle screw spinal systems and reclassified certain post amendments pedicle screw spinal systems. The agency is correcting the rule to include an intended use that was inadvertently omitted from the codified language in the rule. In addition, the agency is correcting the rule to clarify that, when intended for certain uses, the device is a pre amendments, not a post amendments, device. These actions are being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA).

Bone Screws↗
PubMed2001

Gastroenterology-urology devices; classification of tissue culture media for human ex vivo tissue and cell culture processing applications. Final rule.

The Food and Drug Administration (FDA) is classifying tissue culture media for human ex vivo tissue and cell culture processing applications into class II (special controls). The special control that will apply to this device is a guidance document entitled "Class II Special Controls Guidance Document: issue Culture Media for Human Ex Vivo Tissue and Cell Culture Processing Applications; Final Guidance for Industry and FDA Reviewers." The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997. The agency is classifying these devices into class II (special controls) in order to provide a reasonable assurance of the safety and effectiveness of the devices.

Culture Media↗
PubMed2001

Medical devices; exemption from premarket notification requirements; class I devices; technical amendment. Final rule; technical amendment.

The Food and Drug Administration (FDA) is amending the language in its medical device classification regulations for class I devices for consistency, to include in sections where it was not present, a specific reference to the limitations on exemptions from premarket notification requirements for each generic device classified. The specific reference language was included when some class I generic devices were first exempted under provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA). These amendments will provide the same reference for devices that were exempted before that time. The language is intended to conveniently provide the reference, and make the sections clear and easy to read. The status of the devices is not being changed.

Device Approval↗