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Ferdous Al-Faruque

Senior Reporter

Washington, DC

Ferdous Al-Faruque, known as Danny, specializes in reporting on new medical device technologies such as mobile health, combination products, unique device identifiers, and issues surrounding interoperability and cyber security. He is also our resident podcast expert, and has brought listeners the voices of top FDA officials as well as industry leaders. Danny is a big sci-fi fan, especially Battlestar Galactica and Star Trek. Qapla'!'}">Ferdous Al-Faruque, known as Danny, specializes in reporting on new medical device technologies such as mobile health, combination products, unique device identifiers, and issues surrounding interoperability and cyber security. He is also our resident podcast expert, and has brought listeners the voices of top FDA officials as well as industry leaders. Danny is a big sci-fi fan, especially Battlestar Galactica and Star Trek. Qapla'!

Latest From Ferdous Al-Faruque

FDA: Companies Servicing Products Could Get In Hot Water For Remanufacturing

A new draft guidance from the US FDA clarifies what it considers to be remanufacturing. Companies remanufacturing devices are regulated by the agency and may require new premarket applications.

Regulation Guidance Documents

Device Week, 18 June 2021 – MDUFA V Update; FDA’s Shuren Speaks; Harmonized QS Reg Almost Here?

On this week’s podcast we give an update on the Medical Device User Fee Amendments (MDUFA V) process. We also discuss US FDA device center director Jeff Shuren’s comments about pre-submission meetings and IVD submissions during a recent podcast interview with AdvaMed. Finally, we talk about the FDA’s latest scheduling of the release of its draft harmonized Quality System Regulation, due out this month.

Device Week Regulation

Digital Health Roundup, May 2021: Immersive Technologies In Surgery Suite, ‘Smart’ Toilets And Pills; New SaMD Cybersecurity Standards

In this new roundup feature focusing on the most notable developments in digital health, we pick the key news from May.

Digital Health Innovation

MDUFA V: FDA Proposes New Program To Engage External Experts Early – But Industry’s Skeptical

The US agency is asking medtech companies to fund a program that would bring together external experts to advise on their products early on, but industry is skeptical about the program’s ability.

Regulation Policy

Verily’s Study Watch Rejected By FDA As Parkinson’s Drug-Development Tool

US regulators say Verily’s Study Watch – meant to be used in Parkinson’s trials – doesn’t collect data needed to assess whether a patient is truly benefitting from a drug.

Regulation Research & Development

FDA Says SBOMs Are Key To Better Cybersecurity In NIST Report

The US regulator’s report is meant to help develop new federal cybersecurity purchasing guidelines that could eventually be used to implement a cybersecurity consumer labeling program.

Cybersecurity Policy
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