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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

Ordering Starts For Free OTC COVID-19 Tests; USPS Deliveries Expected Within Two Weeks

US consumers can order up to four rapid antigen tests per household through USPS website, or a phone hotline coming soon. Biden administration, which is working to buy another 500m tests soon, notes more OTC tests are becoming available through an accelerated pathway to support FDA reviews of for emergency use authorizations of tests with potential for large-scale manufacturing.

NIH Aims To Stimulate Neuromodulation Device Development With $9.8M Competition

The US medical agency could award up to $800,000 to eight winners in the first phase of the competition. Ultimately, the hope is to develop devices that improve organ function by stimulating the nervous system.

Research & Development Clinical Trials

US Postal Service To Distribute Biden’s Free COVID-19 Rapid Antigen At-Home Tests Starting This Week

Americans can order up to four rapid antigen tests per household through the USPS website now, or a phone hotline soon. The administration is working to buy another half a billion tests in the near future.

Policy Commercial

FDA Codifies Down-Classification For Devices Such As The Apple Watch ECG App

The agency has codified its over-the-counter ECG software class II classification, which means sponsors can continue to benefit from filing for such apps through the less burdensome 510(k) pathway.

Regulation Policy

FDA, Industry To Miss MDUFA V Congressional Deadline; Insiders At Odds Over Future Of Deal

The US agency and the medtech industry still have significant disagreements, which means they will miss a 15 January deadline to send the MDUFA V user-fee deal to Congress. Insiders disagree, however, on how severe those disagreements are and when a deal can be reached.

User Fees FDA

Device Week, 14 January 2022 – Battle For The Right To Repair Devices Heats Up In US States

On this week’s podcast: From Hawaii to Missouri to Florida, the medtech industry and third-party servicers are duking it out in state legislatures over who has the right to repair and service medical devices.

Device Week Legislation
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