Development, Validation, and Innovation in Ophthalmic Laser-Based Imaging: Report From a US Food and Drug Administration-Cosponsored Forum.

In April 2019, the US Food and Drug Administration, in conjunction with 11 professional ophthalmic, vision science, and optometric societies, convened a forum on laser-based imaging. The forum brought together the Food and Drug Administration, clinicians, researchers, industry members, and other stakeholders to stimulate innovation and ensure that patients in the US are the first in the world to have access to high-quality, safe, and effective medical devices. This conference focused on the technology, clinical applications, regulatory issues, and reimbursement issues surrounding innovative ocular imaging modalities.

Breast implant surveillance reports to the U.S. Food and Drug Administration: maternal-child health problems.

There is continuing concern that women who receive breast implants may be at increased risk for adverse reproductive outcomes or experience problems with breastfeeding. It is unknown whether exposure to biomaterials in breast implants may have teratogenic effects or leach into breast milk causing postnatalproblems. We studied the Food and Drug Administration (FDA) experience by analyzing a case series of adverse event reports received and entered into the FDA's Manufacturer and User Facility Device Experience (MAUDE) database or the Device Experience Network (DEN) database by December 31, 2002 regarding women with breast implants.

An overview of Food and Drug Administration regulation of drugs, biologics, and devices to be used for management of periodontal diseases.

The Food and Drug Administration (FDA) has been actively involved in assuring the safety and effectiveness of medical products since 1906. The FDA was granted increased authority to regulate drugs in 1938 and devices in 1976. The regulatory requirements for marketing in the United States vary according to the type of product and the degree of risk associated with it.