October 20, 2022

[FEATURED] EU Proposal To Have Guidance Transition Periods “Does Not Make Sense”

A proposed position paper on time periods for notified bodies to roll out guidance documents aims to introduce greater predictability. But has the EU notified body organization gone too far with its proposals?

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October 15, 2022

[FEATURED] FDA Publishes Final Guidance On Clinical Decision Support Software, Clarifies What Software Should Be Regulated As Medical Devices

In its final document, the US FDA outlines its interpretations of the four criteria for excluding clinical decision support software from being regulated as medical devices under federal law. Software must meet all four criteria to be excluded.

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November 30, 2021

[FEATURED] FDA-Backed Tumor Mutation Database Gives Diagnostics Developers Another Premarket Submission Tool

The US FDA on 7 October recognized a portion of the Oncology Knowledge Base, or OncoKB, which test makers can use as they work to complete premarket submissions. It’s the first database of somatic variants in cancer to be listed in the agency’s Public Human Genetic Variant Databases.


Diagnostics developers now have another tool backed by the US Food and Drug Administration that they can lean on as they work to complete premarket submissions to the agency.

The FDA on 7 October recognized part of a tumor mutation database compiled by the Memorial Sloan Kettering (MSK) Cancer Center. The Oncology Knowledge Base, or OncoKB, is the first database of somatic variants in cancer to be listed in the agency’s Public Human Genetic Variant Databases (PHGVD).

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September 28, 2021

[FEATURED] QSR Q&A: 5 Top Medtech Experts Answer 6 Burning Questions About FDA’s Coming Quality Reg Redo

For this “man on the street” feature, Medtech Insight rounded up industry experts Kim Trautman, Vincent Cafiso, Steve Niedelman, Kwame Ulmer and Josh Levin to answer six questions about the upcoming draft harmonized Quality System Regulation from the US FDA.

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January 5, 2021

FDA Provides Guidance on the Regulation of Multiple Function Products with Some Functions that Fall Outside the Medical Device Umbrella

Author: Suzanne Broussard, PhD  | January 5, 2021

The increasing number and complexity of medical devices with several functions prompted FDA to provide medical device manufacturers with premarket and postmarket regulatory guidance. In a nutshell, FDA states that it shall not regulate non-device functions of a product with multiple functions – but can consider the impact of non-device functions on the device functions. The guidance identifies the principles and premarket review practices, postmarket requirements, and multiple examples of the application of the policy. 

The term “multiple function” device was first officially addressed by FDA in the 21st Century Cures Act Section 3060 that amended the Federal Food, Drug, and Cosmetic Act (FD&C Act). The guidance amended the definition of “device” removing certain software functions (medical and decision software support) and clarifies which software functions (analyze or interpret medical data) remain under FDA’s oversight.    

The Multiple Function Device Products: Policy and Considerations Guidance for Industry and Food and Drug Administration extends that policy to the assessment of all multiple function device products, whether those functions are hardware-based, software-based, or both.  

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