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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'!
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Latest From Ferdous Al-Faruque

Wave Of Overhauled FDA 510(k) Guidance Documents Aims To Streamline Reviews

The US agency has released four updated guidance documents aimed at providing more clarity on how it intends to review 510(k) applications. The FDA says the guidances are intended to reduce unnecessary burdens for its review staff and to help sponsors avoid wasting resources. We break down each of the docs and explain what your company needs to know.

FDA Guidance Documents

Listen: Developing AI Tech Can Mean Walking Through A Patient Privacy Minefield

While artificial intelligence has become the new big thing in medtech, privacy regulations under the Health Insurance Portability and Accountability Act have stayed the same. In this podcast interview with DLA Piper attorney Danny Tobey, Medtech Insight tries to get a clearer picture of what companies need to know in order to avoid running afoul of HIPAA.

Regulation Digital Health

FDA Guidance Aims To Cut Down On Incomplete De Novo Submissions

To help make the review process more efficient, the US agency has published a final guidance that goes into effect in early October that lists items sponsors should submit when filing a de novo application. The FDA has created two checklists to make it easy on de novo sponsors to keep track of the documents and format them appropriately for agency review.

FDA Guidance Documents

Device Week, 30 August 2019: Desperately Seeking Quality Assurance Professionals

In this week’s Medtech Insight podcast, executive editor Shawn M. Schmitt explains how an ongoing "Quality as a Career" initiative from the Medical Device Innovation Consortium (MDIC) is aiming to train the next generation of QA experts.

Device Week Quality

Continued Risks Of Duodenoscopes Leads FDA To Recommend Disposable Cap Devices

After a study earlier this year found that fixed endcap duodenoscopes continued to pose a significant risk of infecting patients after being washed, the US agency is now urging providers to switch to newer-designed scopes that reduce or eliminate the risk from reprocessing, such as duodenoscopes that have interchangeable caps. The directive from the FDA is good news for Boston Scientific, which makes a disposable duodenoscope that is close to being approved by the agency.

Regulation Safety

MDIC Weighs In On Best Way To Inform Patients Of Risks And Benefits

The Medical Device Innovation Consortium has published a white paper that lists what information is needed to ensure that patients understand the risks and benefits of their treatments, as well as what are the most effective means of disseminating that information. Better communication in this area could help patients and physicians choose the right treatment while also helping researchers better inform their clinical-trial subjects.

Regulation Clinical Trials
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