(Germany) +49-(0)-25929626604 | (India) +91-79-48908478

mobile-logo

Articles

Saline, Silicone Gel, and Alternative Breast Implants  

Medical Devices | United States of America

Saline-filled, silicone gel-filled, and alternative breast implants may be indicated for breast augmentation and/or breast reconstruction, which are defined as follows:

Breast augmentation: Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of an original primary breast augmentation surgery (i.e., revision-augmentation).

Breast reconstruction: Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of an original primary breast reconstruction surgery (i.e., revision-reconstruction).

Read More Favorite

Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests  

Medical Devices | United States of America

This document provides guidance for the submission of premarket notification (510(k)) and premarket approval (PMA) applications for diagnostic devices (tests). This guidance addresses the reporting of results from different types of studies evaluating diagnostic devices with two possible outcomes (positive or negative) in PMAs and 510(k)s. The guidance is intended for both statisticians and non-statisticians.

Read More Favorite

Pre-Clinical and Clinical Studies for Neurothrombectomy Devices  

Medical Devices | United States of America

A neurothrombectomy device is intended to retrieve or destroy blood clots in the cerebral neurovasculature by mechanical (i.e., snare or suction), laser, ultrasound technologies, or combination of technologies.

The regulatory pathway, i.e., premarket notification submission (510(k)), de novo classification, or premarket approval application (PMA), for a neurothrombectomy device depends on the identification of an appropriate predicate device, the technology of the device, and its indications for use. Mechanical neurothrombectomy devices indicated for retrieval of clots in patients with ischemic stroke are regulated as class II devices.

 

Read More Favorite

Bundling Multiple Devices or Multiple Indications in a Single Submission  

BiologicalsMedical Devices | United States of America

Bundling refers to the inclusion of multiple devices or multiple indications for use for a device in a single premarket submission, including products subject to the device and biologics license application (BLA) authorities, for purposes of review and user fee payment. In CBER, the term may also include the designation of separate submissions as one premarket submission for review and user fee payment. Multiple devices may include different models within a generic type of device2 or devices that are of differing generic types.

Read More Favorite

Compliance Guide for Cabinet X-Ray Systems  

Medical Devices | United States of America

Cabinet x-ray systems sold in the U.S. are required to comply with all applicable requirements of the performance standard. Before selling a cabinet x-ray system in the U.S., a manufacturer must certify that its product meets the applicable requirements of the performance standard. This certification must be based on a quality control and testing program that is in accordance with good manufacturing practices.

Read More Favorite

Biological Indicator (BI) Premarket Notification [510(k)] Submissions  

Medical Devices | United States of America

This document provides guidance concerning the content and format of 510(k) submissions for BIs intended to monitor sterilization processes used in health care facilities (product code, FRC). These are Class II devices identified under 21 CFR 880.2800(a):
A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of a known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.

Read More Favorite

The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations  

Medical Devices | United States of America

The following will be addressed in this guidance:
• The sequence of events as the Office of Compliance (OC) or the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) reviews the manufacturing section of a PMA;
• The administrative process and projected timeframes involved with each step; and
• How the inspection of a manufacturing facility fits into the approval process.

Read More Favorite

Coronary and Carotid Embolic Protection Devices – Premarket Notification [510(k)] Submissions  

Medical Devices | United States of America

This guidance document addresses coronary and carotid embolic protection devices. Typically, the embolic protection device is deployed proximal or distal to a lesion (narrowed portion of the vessel) prior to other intervention taking place, such as balloon angioplasty or stenting. The embolic protection device is intended to prevent debris generated by the intervention from traveling downstream in the coronary or carotid circulation where it could impede flow partially or fully in smaller vessels, leading to damage to the myocardium or to neurological impairment. These devices are classified as percutaneous catheters.

The scope of this guidance includes embolic protection devices used along with other interventional devices (e.g., stents or angioplasty balloons) for the treatment of:
• Diseased saphenous vein grafts (SVGs) in patients with stable ischemic coronary artery disease; and
• Diseased carotid arteries that could potentially contribute to strokes or other neurological adverse events.

Read More Favorite