Usb Device Vid
Kerrie Gingrich
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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.
The Breakthrough Devices Program offers manufacturers an opportunity to interact with FDA experts through several different program options to efficiently address topics as they arise during the premarket review phase. This interaction can help manufacturers receive feedback from the FDA and identify areas of agreement in a timely way. Manufacturers can also expect prioritized review of their submission. Learn more about the Breakthrough Devices Program principles and features in Sections II and IV of the Breakthrough Devices Program final guidance.
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:
You can send a Breakthrough designation request for your device at any time before sending your marketing submission (for example, premarket approval [PMA], premarket notification [510(k)], or De Novo classification request).
You can request Breakthrough Device designation by submitting a "Designation Request for Breakthrough Device" Q-Submission. Your designation request should be the only request in the Q-Submission. If you are pursuing the Breakthrough Device designation while you have other requests for feedback pending, you may want to send the requests for feedback after the FDA makes a designation decision, because the designation may affect the feedback that the FDA provides on your other requests. The procedures for submitting a Q-Submission are outlined in the guidance, Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.
The FDA intends to request any other information needed to inform the Breakthrough Device designation decision within 30 days of receiving your request. You can expect to receive a letter communicating the FDA's decision to grant or deny the Breakthrough Device designation request within 60 calendar days of the FDA receiving your request.
It is helpful when you are available and responsive to the FDA's requests throughout the review timeline. If the FDA does not receive the needed information to decide on a designation request promptly, it may result in denial of the Breakthrough Device designation request.
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 December 31, 2023, CDRH and CBER have granted 933 Breakthrough Device designations, including devices originally designated under the Expedited Access Pathway (EAP) program. Of the 933 devices granted Breakthrough Device designation, CDRH has granted 921 and CBER has granted 12.
*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.
The ultimate judgment regarding whether a BP measurement device meets the requisite VDL Criteria rests with the Independent Review Committee and is not in any way determined or influenced by the AMA.
The Independent Review Committee, comprised of physician experts, assesses if a BP device satisfies the VDL Criteria for validation of clinical accuracy. Devices that meet the Criteria are then published on the listing page. Devices are regularly reviewed and added through this independent process.
The International Medical Device Regulators Forum (IMDRF) acknowledges the significant impact of the COVID-19 pandemic on all countries and citizens. The use of essential medical devices such as ventilators, oxygen concentrators, syringes and test kits contributed to the efforts of pandemic responses around the world, as with other products regulated in some countries such as surgical face masks.
The IMDRF held a Joint Workshop on COVID-19 in March 2021 and held regular discussions about the impacts, experiences and challenges during the pandemic. Members continue to share information about changes made to regulatory frameworks that aim to assist preparations for future pandemics. Some of these included emergency use or other systems to expedite access and supply of essential medical devices, flexible and pragmatic approaches to regulatory processes such as remote inspections, and publishing information about approval pathways and availability of critical medical devices.
When you let your organization manage your Apple iOS device, you agree to allow your administrator to control some data and features on the device. You can check which device features your administrator controls (details later). If you have questions about the specific features, contact your IT administrator.
If you access multiple Google Accounts on your device, your organization can control data only from your work or school account. For example, if you have a personal Gmail account and a work email account, only information from the work account is available to your employer. Browser activity in private or Incognito mode in Chrome Browser or Apple Safari stays private.
You can only have one account with a configuration profile on your device. To use a different account with a configuration profile, remove the existing account and the associated configuration profile. Then, install the profile with the new account. For details on configuration profiles and how to remove them, go to Manage a Google configuration profile.
If your organization has full control of your device (device enrollment), an administrator can also wipe the entire device, including all of your personal apps and data. Some organizations require this action if your device is lost or stolen. If your administrator remotely wipes the entire device, you can restore your personal content using an Apple iCloud or iTunes backup. For details on restoring data, see your Apple documentation.
Your administrator might maintain a list of apps for you to install on your device. You can access these apps from the Google Device Policy app and install them for free. Your administrator can remove apps and associated data from your device. They can also remotely deliver app settings to your device and decide whether you can do the following actions:
When you back up your iOS device to iTunes, your administrator might require that you encrypt the backup. An encrypted backup is stored on your computer. You can use it to restore your device. When your administrator turns on this setting, iTunes asks you to enter a password. You need to enter this password to restore your iOS device.
These principles are reflected throughout the architecture that enables Apple Intelligence, connects features and tools with specialized models, and scans inputs and outputs to provide each feature with the information needed to function responsibly.
In the remainder of this overview, we provide details on decisions such as: how we develop models that are highly capable, fast, and power-efficient; how we approach training these models; how our adapters are fine-tuned for specific user needs; and how we evaluate model performance for both helpfulness and unintended harm.
Our foundation models are trained on Apple's AXLearn framework, an open-source project we released in 2023. It builds on top of JAX and XLA, and allows us to train the models with high efficiency and scalability on various training hardware and cloud platforms, including TPUs and both cloud and on-premise GPUs. We used a combination of data parallelism, tensor parallelism, sequence parallelism, and Fully Sharded Data Parallel (FSDP) to scale training along multiple dimensions such as data, model, and sequence length.
We train our foundation models on licensed data, including data selected to enhance specific features, as well as publicly available data collected by our web-crawler, AppleBot. Web publishers have the option to opt out of the use of their web content for Apple Intelligence training with a data usage control.
In addition to ensuring our generative models are highly capable, we have used a range of innovative techniques to optimize them on-device and on our private cloud for speed and efficiency. We have applied an extensive set of optimizations for both first token and extended token inference performance.
Both the on-device and server models use grouped-query-attention. We use shared input and output vocab embedding tables to reduce memory requirements and inference cost. These shared embedding tensors are mapped without duplications. The on-device model uses a vocab size of 49K, while the server model uses a vocab size of 100K, which includes additional language and technical tokens.
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