HDE definition

HDE means Health Data Enterprise.

HDE means a humanitarian device exemption filing made with the FDA or an analogous filing outside the United States made with a Regulatory Authority for the applicable jurisdiction.

HDE means Humanitarian Device Exemption, a regulatory pathway for products intended for diseases or conditions that affect small, rare populations.

Examples of HDE in a sentence

• To be considered for HUD status, a device sponsor must submit a humanitarian device exemption (HDE) application to the FDA.

• The applicant must demonstrate that no comparable devices are available for the use intended for the device in question and that the applicant device could not be brought to market without the conditions of the HDE.

• An HDE holder shall main- tain records of the names and addresses of the facilities to which the HUD has been shipped, correspondence with re- viewing IRB’s, as well as any other in- formation requested by a reviewing IRB or FDA.

• Upon approval of the HDE, the Company would be able to offer this device to as many as 4,000 patients per year.

• Graduate Units in Human DevelopmentHDE 200A: Early Development 4 unitsHDE 200B: Middle Childhood and Adolescence 4 unitsHDE 200C: Development in Adulthood 4 units HDE 220: Research Methods in Human Growth and Development 4 units HDE 291: Research Issues in Human Development 4 units General Biological Sciences (see pg.

• A HDE application is not required to contain the results of scientifically valid clinical investigations demonstrating that the device is effective for its intended purpose.

• An HDE applicant is required to submit reports in accord- ance with the approval order.

• In the interest of furthering community health through the power of data, ESO encourages Customers subscribing to ESO’s Health Data Exchange (“HDE”) Software to empower joint healthcare providers by incorporating relevant, HIPAA- compliant data elements in Customer’s outgoing patient care records delivered through HDE.

• Information describing the appli- cant’s clinical experience with the de- vice since the HDE was initially ap- proved.

• An HDE holder may wish to ensure that this happens by not shipping the HUD to the facility until it has received confirmation of IRB approval.

More Definitions of HDE

HDE means a Humanitarian Device Exemption pursuant to the Safe Medical Devices Act of 1990 and the FDA regulations at 21 CFR Part 814, Subpart H. or a comparable regulatory designation in any other country.

HDE shall have the meaning set forth in the Recitals.

HDE means Hilite Industries-Delaware, Inc., a Delaware corporation.

HDE means a premarket approval application submitted pursuant to this subpart seeking a humanitarian device exemption from the effectiveness re- quirements of sections 514 and 515 of the act as authorized by section 520(m)(2) of the act.