Download Device Programming Algorithm

The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

The Breakthrough Devices Program replaces the Expedited Access Pathway and Priority Review for medical devices. The FDA considers devices granted designation under the Expedited Access Pathway to be part of the Breakthrough Devices Program.

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Devices subject to premarket approval applications (PMAs), premarket notification [510(k)], or requests for De Novo classification request are eligible for Breakthrough Device designation if the device meets both of the following criteria:

If your device is not eligible for a Breakthrough Device designation because it is not intended for the treatment or diagnosis of a life-threatening or irreversibly debilitating human disease or condition, you may consider whether or not your device would be a candidate for the Safer Technologies Program.

Before issuing a marketing authorization, the FDA generally cannot publicly disclose whether a sponsor has submitted a Breakthrough Device designation request for a device or whether the FDA has granted or denied the request, unless the sponsor decides to make that information available to the public.

Additionally, the FDA maintains on its website a list of devices granted Breakthrough Device designation that have received marketing authorization, adding devices to the list once the device has received marketing authorization.

As of June 30, 2023, CDRH and CBER have granted 839 Breakthrough Device designations, including devices originally designated under the Expedited Access Pathway (EAP) program. Of the 839 devices granted Breakthrough Device designation, CDRH has granted 831 and CBER has granted 8.

*Data includes devices that were designated under the precursor Expedited Access Pathway (EAP). Since the vision and designation criteria between the precursor EAP Program and the Breakthrough Devices Program are consistent, the FDA considers devices granted designation under the EAP to be a part of the Breakthrough Devices Program.

One of the things I thought for optimizing the code was to use device pointers instead of host pointers in thrust inputs, but I tried with a simple program, and I keep getting segmentation fault. I was wondering if anyone could point me in the right direction. Here is the code:

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If you have a question you can start a new discussionFlash Programming Algorithm is not in listAriover 2 years agoHi, 2351a5e196