Here are four things to know about the new steps.
1. The FDA established a 23-item questionnaire to measure health information from patients with heart failure. The questionnaire, called a medical device development tool, will provide an objective platform to facilitate the development of devices for cardiovascular health.
2. The agency will also issue three new guidance documents for medical device manufacturers.
3. The first draft guidance enables a quicker pre-submission process for breakthrough drugs under the FDA’s Breakthrough Devices Program. This program was recently established to help patients more quickly access certain devices for life-threatening or debilitating diseases.
4. The other two documents modify the 510(k) notification process. The 510(k) notification is a premarket submission made the FDA to demonstrate the device will be marketed safely and effectively, according to the FDA website.
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