의료기기 이야기

A companion diagnostic device can be in vitro diagnostic (IVD) device or an imaging tool that provides information that is essential for the safe and effective use of a corresponding therapeutic product. Below is a table of cleared or approved companion diagnostic devices (in vitro and imaging). The use of an IVD companion diagnostic device is stipulated in the instructions for use in the labeli..

SummaryThe Food and Drug Administration (FDA) is announcing a public workshop entitled “Accreditation Scheme for Conformity Assessment and Use of Chemical Analysis to Support Biocompatibility of Medical Devices.” The purpose of this public workshop is for the FDA to discuss with stakeholders the expansion of the Accreditation Scheme for Conformity Assessment (ASCA) program to include chemical an..

SummaryOn October 24, 2024, the U.S. Food and Drug Administration (FDA) will host a webinar for laboratory manufacturers and other interested parties to discuss the FDA’s Total Product Life Cycle (TPLC) approach to the oversight of in vitro diagnostic products (IVDs). The FDA’s TPLC approach allows the FDA to review and monitor medical devices throughout their life cycle by taking into account a..

This guidance document provides the FDA’s recommendations on performance criteria to support premarket submissions for endosseous dental implants and abutments in the Safety and Performance Based Pathway. Under this framework, submitters planning to submit a 510(k) using the Safety and Performance Based Pathway for endosseous dental implants and abutments will have the option to use the performa..

Overview of Threshold Analyses for Combination ProductsThreshold analyses help determine if differences related to external critical design attributes lead to additional use-related risks to the end user when comparing a proposed generic product to a reference product. The methodology for threshold analyses is described by the U.S. Food and Drug Administration (FDA) draft guidance document relea..

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..

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..