Search Results for keywords:"medical devices"

The Food and Drug Administration (FDA) has submitted a proposed information collection to the Office of Management and Budget (OMB) for review, as required under the Paperwork Reduction Act of 1995. This proposal relates to tracking certain high-risk medical devices, which helps to quickly locate devices and notify patients or practitioners about recalls or risks. The collection applies to manufacturers, importers, and distributors of these medical devices, and aims to ensure effective tracking and information sharing in case of device defects. The FDA has estimated that the annual burden for respondents is around 615,380 hours, with approximately 22,000 entities subject to these tracking requirements.

The Food and Drug Administration (FDA) is seeking public comments on the proposed collection of information related to exports of products such as drugs, biologics, and medical devices that are not sold in the U.S. This request is part of the requirements under the Paperwork Reduction Act of 1995, and comments are due by June 30, 2025. The goal is to collect opinions on whether the information collection is necessary, its accuracy, and ways to reduce the burden on respondents. The notification and recordkeeping requirements mostly apply to exporters who must follow specific guidelines to ensure their products meet the standards of the destination countries.

The Food and Drug Administration (FDA) is holding a virtual public advisory committee meeting on March 23, 2021. The meeting is organized by the General and Plastic Surgery Devices Panel and is part of the Medical Devices Advisory Committee. The discussion will focus on the benefits and risks of dermal fillers, specifically addressing risks related to intravascular injection and patient decision-making. Members of the public can attend the meeting online and are encouraged to contribute data, information, or views either in writing by March 9, 2021, or orally during the meeting.

The Food and Drug Administration (FDA) is asking for public feedback on gathering certain data about reprocessed, single-use medical devices under the Paperwork Reduction Act. This public comment period lasts for 60 days, ending on April 26, 2021. The FDA wants to know if the information collection is necessary, how accurate their burden estimates are, and if there are better ways to collect data. This initiative aims to ensure that reprocessed devices clearly show the manufacturer's name or symbol to prevent misbranding, as required by federal law.

The Food and Drug Administration (FDA) is inviting industry organizations to participate in selecting nonvoting representatives for the Patient Engagement Advisory Committee, which discusses the use and regulation of medical devices. These nonvoting representatives can be nominated either by the organizations or through self-nomination and should be experienced in fields related to medical devices. Organizations interested in participating must notify the FDA by January 29, 2025, and nominations should be submitted by the same date. The FDA is particularly looking for individuals with expertise in areas like cybersecurity, digital health, patient engagement, and health equity.

The Food and Drug Administration (FDA) has released a notice regarding updates to the list of standards used in assessing medical devices, known as the "FDA Recognized Consensus Standards." These updates, called "Recognition List Number: 063," help manufacturers who wish to align their products with these standards. People can submit comments or suggestions for additional standards anytime, and the FDA keeps a database of the recognized standards available online. The updated list of standards is effective from March 20, 2025.