Activation Device

[Odon Irving]

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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.

This is a base resource that tracks individual instances of a device and their location. It is referenced by other resources for recording which device performed an action such as a procedure or an observation, which device was implanted in or explanted from a patient, dispensing a device to a patient for their use, managing inventory, or when requesting a specific device for a patient's use. Medical devices include durable (reusable) medical equipment, implantable devices, as well as disposable equipment used for diagnostic, treatment, and research for healthcare and public health. Medical devices may also include some types of software.

Non-medical devices may include items such as a machine, cellphone, computer, software application or algorithm, etc. In short, a Device can range from a tongue depressor to an MRI. The fields in the Device resource must be flexible enough to cover this range.

The resource may be used to document the Unique Device Identifier (UDI) and information about a device where appropriate or necessary according to local jurisdictions over time. Additional information about UDI is provided in the Unique Device Identifier (UDI) section.

Devices may be categorized and may be associated with one or more categories. Device category examples include, but are not limited to: active, communicating, durable medical equipment, home use, implantable, InVitro diagnostics, personal health, point-of-care, single use, re-usable, and software.

'Active device' means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices. Software shall also be deemed to be an active device. MDR (EU) 2017/745

Active Implantable Medical Devices include the definition for both active devices and implantable devices (see below). Examples include: Implantable cardiac pacemakers; Implantable defibrillator; Implantable neurostimulator systems; Leads, electrodes, adaptors for implantable pulse generators; Brachytherapy systems; Ventricular Assist Devices (VADs); Cochlear implants; Implantable infusion pumps; Implantable glucose monitors; Micro Electro-Mechanical Systems (MEMS); and their accessories where applicable.

This category of devices communicates electronically to peer information systems or possibly another device. In addition to patient observations for use by clinicians in providing care and for building a health record, the device communicates metadata about its own state and the protocol used to transfer that information.

To support the use and evaluate the reliability of the patient data, it is important to to collect and record data about the identity and operational status of the device that generated the observations. The Device resource is an important locus for such information. The information it generates for clinical and other purposes goes into other resources such as the Observation or Medication resource depending upon what the device does. To support device-related information about Communicating Medical Devices the Device resource needs to have elements that describe not only the basic information like the serial number, manufacturer name and model number, but information about the protocol, its version, its certification, the properties it has to perform its purposed tasks such as internal clocks, synchronization state, resolution, etc.

Equipment and supplies that provides therapeutic benefits to a patient in need because of certain medical conditions and/or illnesses, and which are ordered by a health care provider for everyday or extended use.

Examples include: oxygen equipment, suction pumps, traction equipment, home infusion services, continuous positive airway pressure (CPAP) devices, hospital beds, wheelchairs, crutches walkers, canes, or blood testing strips and meters for diabetics.

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