Tag Archives: FDA

New User Fees Set for Foreign Medical Device Manufacturers in China

Chinese medical device market regulator China Food and Drug Administration (CFDA) has published a draft table of user fees for medical device registrants, and is expected to begin enforcing fee requirements in March 2015.

Chinese medical device market regulator China Food and Drug Administration (CFDA) has published a draft table of user fees for medical device registrants, and is expected to begin enforcing fee requirements in March 2015.

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FDA’s Single Audit Program Invites Participants

The MDSAP pilot has reached a major milestone with manufacturers around the globe interested in marketing medical devices in Australia, Brazil, Canada, and the U.S. invited to participate in the program.

The MDSAP pilot has reached a major milestone with manufacturers around the globe interested in marketing medical devices in Australia, Brazil, Canada, and the U.S. invited to participate in the program.

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Trends to Watch For in Medical Device Industry

Access to recently developed materials, new technological deliveries and access to new markets are only a few of the trends that have affected changes in the medical device market and industry.

Access to recently developed materials, new technological deliveries and access to new markets are only a few of the trends that have affected changes in the medical device market and industry.

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Apps: Fun or Medical Devices?

Popularity of smartphone applications, or apps, has increased explosively. Among the implemented functionality, more and more medical device features have started to creep in. In this article, we discuss when an app is simply fun and when it needs to be regulated as a medical device.

Popularity of smartphone applications, or apps, has increased explosively. Among the implemented functionality, more and more medical device features have started to creep in. In this article, we discuss when an app is simply fun and when it needs to be regulated as a medical device.

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Reimbursement Report

Humanitarian Use Devices and Third-Party Reimbursement

By Elizabeth Brown, MD

Payers often apply the same evidence standards to Humanitarian Use Devices as other devices and demand high quality clinical trials, following an approach similar to the PMA or 510(k) regulatory pathways, where payers frequently impose a higher evidence standard than FDA. But how flexible are payers in setting their evidence requirements? Will they consider HUDs as investigational?

Payers often apply the same evidence standards to Humanitarian Use Devices as other devices and demand high quality clinical trials, following an approach similar to the PMA or 510(k) regulatory pathways, where payers frequently impose a higher evidence standard than FDA. But how flexible are payers in setting their evidence requirements? Will they consider HUDs as investigational?

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