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Senior Reporter
Washington DC, USA
9+ years of experience
Medtech Insight
By Ferdous Al-Faruque 14 Jan 2022
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.
Medtech Insight
By Ferdous Al-Faruque 30 Nov 2021
The MITRE corporation and MDIC have produced a manual on how to use cybersecurity threat modeling to make safer medical devices. The document asks four basic questions and provides helpful examples.
Medtech Insight
By Ferdous Al-Faruque 14 Sep 2021
The US Medicare agency has proposed to withdraw a rule that would give temporary automatic coverage to breakthrough devices, stating the rule doesn’t meet its evidence threshold and could put patients at risk.
Medtech Insight
By Ferdous Al-Faruque 17 Mar 2021
The report looks at a broad range of submission and product types and concludes use of RWE/RWD has helped get new products to market faster.
Medtech Insight
By Ferdous Al-Faruque 27 Nov 2020
As concerns continue to mount over a potential shortage of medical devices due to the closure of ethylene oxide (EtO) facilities, the US agency is looking for nine sterilizers in a pilot project that could allow them to get facility and process changes approved faster.
Topic Approvals Compliance Regulation
Medtech Insight
By Ferdous Al-Faruque 08 Jan 2020
The US agency says in a 6 January Federal Register notice that it’s keeping its Patient Engagement Advisory Committee in place through October 2021 so it can gather more patient feedback that will come in handy when regulatory decisions need to be made. The committee, formed after the agency made a cultural shift to consider patient input on the types of products it allows on the market, was supposed to expire October 2019.
Topic advisory committees FDA Regulation
Medtech Insight
By Ferdous Al-Faruque 08 Nov 2019
Medtronic’s director of quality sterilization and microbiology, Phil Cogdill, sat down with Medtech Insight to talk about setting new ethylene oxide (EtO) standards and what his takeaways were from the first day of a US FDA meeting to understand how to mitigate potential product shortages from closures of EtO sterilization facilities. Check out our podcast here.
Topic FDA
Medtech Insight
By Ferdous Al-Faruque 26 Jul 2019
In a midyear update from the FDA, regulators say a retrospective review of companies in its pre-cert pilot program has concluded that evaluating a company for excellence markers could be sufficient to let Software as a Medical Device (SaMD) onto the market. However, at least one critic says the update doesn’t answer some of the most critical questions about whether the program meets the agency's own requirements and if it creates unfair advantages for certain companies.
Topic FDA Policy & Regulation
Medtech Insight
By Ferdous Al-Faruque 02 Jul 2019
International regulators are interested in seeing how they too can apply the US FDA’s precertification program, which is currently in the pilot stage. In an exclusive interview with Medtech Insight, the agency’s top digital health officer, Bakul Patel, talks about global curiosity about the program that could allow companies to get certain medical software on the market based on trust. Patel also expects an upcoming artificial intelligence draft guidance from the FDA will form from a recent discussion paper – but he says industry needs to do more.
Topic Medtech
Medtech Insight
By Ferdous Al-Faruque 26 Jun 2019
Almost four years after the agency first authorized a prostate ablation device, regulators have proposed a number of requirements for clinical studies that sponsors would have to meet to comply with special controls needed for the devices to be cleared for marketing.
Topic FDA Medtech Policy & Regulation
Pink Sheet
By Ferdous Al-Faruque 15 Jun 2019
As the partial US government shutdown enters its second month, the backlog of device pre-market applications is building. AdvaMed is proposing language that would allow FDA to accept and review new user-fee-funded submissions during government shutdowns.
Topic US Shutdown FDA
Medtech Insight
By Ferdous Al-Faruque 13 Jun 2019
CVRx CEO Nadim Yared has moved up on the board of directors at the Medical Device Innovation Consortium as its new chair. The public-private partnership group that formed in 2012 has been effective in working with the US Food and Drug Administration to develop new regulations.
Medtech Insight
By Ferdous Al-Faruque 13 Jun 2019
US regulators are proposing makers of fertility assistant devices first test their products on mice embryos in the lab to better understand any potential toxicity risk to human embryos and the viability of the fetus.
Topic FDA Policy & Regulation
Medtech Insight
By Ferdous Al-Faruque 11 Jun 2019
AdvaMed's top lobbyist says a new documentary critical of the medical device industry and US FDA's device review pathways is unlikely to result in Congressional action. However, the group is talking to members on Capitol Hill to make sure they fully understand the context within which devices are reviewed and marketed.
Medtech Insight
By Ferdous Al-Faruque 11 Jun 2019
In 2019, FDA will be taking steps to perform real-world testing of the effectiveness of its pre-cert program for health software and whether the program can be carried out within the agency's current regulatory authorities. The efforts come after more than a year of development and some pushback about statutory overreach and patient safety.
Topic FDA
Medtech Insight
23 Feb 2022
Medtech Insight
18 Feb 2022
Medtech Insight
15 Feb 2022
Medtech Insight
14 Feb 2022
HBW Insight
13 Feb 2022
Medtech Insight
11 Feb 2022
Medtech Insight
11 Feb 2022
Medtech Insight
08 Feb 2022
Medtech Insight
07 Feb 2022
Medtech Insight
03 Feb 2022
Medtech Insight
31 Jan 2022
Medtech Insight
28 Jan 2022
Medtech Insight
25 Jan 2022
Medtech Insight
24 Jan 2022
Medtech Insight
24 Jan 2022
