의료기기 이야기

There are currently 53 devices enrolled in the FDA’s TAP Pilot.On October 1, 2024, the Total Product Life Cycle Advisory Program (TAP) Pilot expanded to include medical devices reviewed by the Division of Ophthalmic Devices (DHT1A) and the Office of Radiological Health (OHT8).The TAP Pilot is now accepting enrollment requests for Breakthrough Designated devices reviewed by the:Division of Ophtha..

After announcing the implementation of minor technical changes to the instructions for the required malfunction summary reporting format in alignment with the current version of Form FDA 3500A, the U.S. Food and Drug Administration (FDA) has finalized its 2022 draft guidance document, Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers. This resource outlines the principles ..

BackgroundMedical device manufacturers must conduct appropriate testing to demonstrate that their devices are appropriately safe and effective before sale in the US. In many cases some animal and/or microorganism testing, such as to demonstrate biocompatibility, is required to obtain U.S market authorization.In February 2024, the U.S. Food and Drug Administration (FDA) noted concern that some th..

We last wrote about the U.S. FDA eSTAR when it became compulsory for 510(k)s. At the time, the eSTAR was voluntary for De Novos. Background on De NovosThe De Novo Classification Request “De Novo” is the regulatory mechanism used when manufacturers have a novel medical device that they expect is not high risk and so should be Class II (special controls and general controls) or Class I (general co..

In its August 22 webinar, the U.S. Food and Drug Administration (FDA) discussed the Stage 1 requirements imposed on laboratory-developed test (LDT) manufacturers.U.S. FDA Final Rule on LDTsLDTs are in vitro diagnostic devices (IVDs) that are designed, manufactured and used within a single clinical laboratory and were placed under enforcement discretion in 1976 with the medical device amendments ..

Today, the U.S. Food and Drug Administration expanded the indications of the Insulet SmartAdjust technology, an interoperable automated glycemic controller previously indicated for the management of type 1 diabetes in individuals two years and older, to also include management of type 2 diabetes in individuals 18 years and older. An interoperable automated glycemic controller is software that au..

We at Emergo by UL would like to point out that the U.S. Food and Drug Administration (FDA) has recently adapted certain searches and information to highlight regulatory guidance for specific medical device types. Medical device and IVD manufacturers who want to stay ahead of regulatory changes to avoid market access disruptions should take note.  Searching FDA guidance documentsThe U.S. FDA  ha..

The U.S. Food and Drug Administration (FDA) issued a new draft human factors engineering (HFE) guidance document, Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products, on July 8, 2024. The guidance informs manufacturers of drug- and biologic-led combination products about the purpose and content of a use-related risk analysis (URRA) and how a ..

The FDA has been working with COVID-19 test developers seeking to pursue marketing authorization through the traditional premarket review pathways, which will allow these tests to continue to be used beyond the time allowed by emergency use authorization.  This page lists COVID-19 tests that have received traditional marketing authorization. See the Marketing Your Device page for more informatio..

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