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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

US FDA Adds 14 New Regulatory Tools To Help It Review Medical Devices

The tools include new laboratory methods, and computational models and simulations give the agency more capabilities to test and validate data in premarket submissions.

Regulation FDA

Benefits Of Non-Regulated Medical Software Far Outweigh Their Risks: Report

The US FDA’s latest report on non-regulated health and medical software finds they are not associated with any substantial increase in risks, though the agency admits there may be some underreporting.

Safety Digital Health

FDA Offers Even More Detailed Recommendations In EMC Draft Guidance

Four years after finalizing its electromagnetic compatibility (EMC) guidance, the US agency has proposed a draft guidance that would add significantly more details in terms of what regulators want from a sponsor’s premarket application.

Regulation Approvals

COVID-19 Brings Additional Cybersecurity Challenges To Health Care Sector: Experts

The coronavirus pandemic means more use of telehealth and hospital staff having to work remotely, which increases opportunities for malicious hackers to take advantage of the situation, experts tell Medtech Insight.

Cybersecurity Safety

Device Week, 13 November 2020 – US News: FDA Plans Virtual Inspections Pilot; Enforcement In The Era Of COVID-19; And More

On this week’s podcast: The US FDA is plotting a pilot program that will allow agency investigators to conduct virtual facility inspections; enforcement experts say pandemic cleanup efforts could last for years; a peek ahead as to how quickly President-elect Joe Biden will fill top roles at the HHS and the FDA; and more.

Device Week FDA

Experts: Biden Will Rush To Fill HHS, FDA Posts; Georgia Senate Races May Decide ACA’s Fate

Attorneys predict the upcoming Biden administration will try to quickly fill top leadership positions at the HHS and the FDA, and note that January’s two Senate runoff elections in Georgia could decide the fate of the Affordable Care Act before the Supreme Court does.

Elections Leadership
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