The US Food and Drug Administration (FDA) finalized guidance on the Humanitarian Device Exemption (HDE) program on Thursday, reflecting amendments made by the 21st Century Cures Act (Cures Act) and the FDA Reauthorization Act (FDARA).

What is the HDE program?

The HDE program is a regulatory pathway created in the Medical Devices Act of 1990 by Congress that allows medical devices to be marketed without evidence of effectiveness. The program is available to manufacturers of devices intended to treat or diagnose rare diseases or conditions that affect less than 8,000 individuals in the United States per year. Previously at 4,000 patients, the Cures Act increased the number in 2017. As rare conditions and diseases only occur in a small number of patients, HDE was created in an effort to combat the difficulty of gathering enough clinical evidence to meet FDA standard of reasonable assurance of safety and effectiveness.

Humanitarian use devices (HUDS) are the devices that have been approved through the program and are exempt from having to demonstrate assurance of effectiveness. To pass, device manufacturers must prove that similar devices do not exist and that there is no alternative way to bring the device to market.

The Finalized Guidance

Following the issuance of the draft in June 2018, the finalized guidance remains largely the same but is used to clarify current HDE review practices, post-approval requirements, appendices related to benefit-risk assessments, and special considerations for devices that fall under the pathway. 

The first amendment clarifies the criteria FDA considers to determine “probable benefit” for marketing authorization for a HUD by listing the types of evidence that may be used to support approval of an HDE application:

  • Investigations involving human subjects
  • Investigations using laboratory animals
  • Nonclinical investigations
  • Analytical studies for in vitro diagnostics

Moreover, the FDA refines the section on “IRB or Appropriate Local Committee Oversight,” by defining an appropriate local committee as having expertise and experience in making and reviewing treatment decisions and applying medical device technologies to clinical care. They include a specific list of examples that may be deemed as appropriate:

  • physicians with experience in the treatment of rare diseases or conditions
  • a peer review committee, a credentialing committee, or a Quality Care Committee
  • a senior executive level medical staff or faculty member (e.g., the Chief Medical Officer, Physician-in-Chief, Surgeon-in-Chief, Department Chair)

Lastly, the FDA explains when an HDE can be suspended or withdrawn, noting, “We intend to discuss the regulatory options with the HDE holder before revoking a HUD designation.”

How RegDesk Can Help

RegDesk’s platform provides medical device manufacturers with the latest updates on the most important regulations regarding the HDE program. With our service, medical device and pharmaceutical companies have access to the most recent amendments and requirements implemented to maintain compliance and to be able to distribute medical devices on the market without having to provide substantial evidence of effectiveness. RegDesk provides well-structured and reliable information on humanitarian use device regulations to help medical device manufacturers deal with regulatory issues. Along with the FDA, RegDesk also provides information for over 100 markets worldwide to help medical device and pharmaceutical companies expand internationally.

 

 

 

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    La respuesta que da la Biblia es:
    Dios fue manifestado en carne, Justificado en el Espiritu, Visto de los angeles, Predicado a los gentiles, Creido en el mundo, Recibido arriba en gloria. 1 Timothy 3:16
    Este es el verdadero Dios, y la vida eterna. 1 John 5:20
    Porque un nino nos es nacido, hijo nos es dado, y el principado sobre su hombro; y se llamara su nombre Admirable, Consejero, Dios Fuerte, Padre Eterno, Principe de Paz. (Isaias 9:6)
    He aqui, una virgen concebira y dara a luz un hijo, Y llamaras su nombre Emanuel, que traducido es: Dios con nosotros. (Mateo 1:23)
    Un gran profeta se ha levantado entre nosotros; y: Dios ha visitado a su pueblo.
    Y se extendio la fama de el por toda Judea, y por toda la region de alrededor. (Lucas 7:16,17)
    y la palabra que habeis oido no es mia, sino del Padre que me envio. (John 14:24)
    y el que me ve, ve al que me envio. (John 12:45)
    El que a vosotros recibe, a mi me recibe; y el que me recibe a mi, recibe al que me envio. (Mateo 10:40)

    Que hacer?
    Entonces le dijeron: їQue debemos hacer para poner en practica las obras de Dios?
    Respondio Jesus y les dijo: Esta es la obra de Dios, que creais en el que el ha enviado. (John 6:28,29)
    Ellos dijeron: Cree en el Senor Jesucristo, y seras salvo, tu y tu casa. (Hechos de los apostoles 16:31)
    De cierto, de cierto os digo: El que oye mi palabra, y cree al que me envio, tiene vida eterna; y no vendra a condenacion, mas ha pasado de muerte a vida. (John 5:24)
    Respondiendo el al que le decia esto, dijo: їQuien es mi madre, y quienes son mis hermanos?
    Y extendiendo su mano hacia sus discipulos, dijo: He aqui mi madre y mis hermanos.
    Porque todo aquel que hace la voluntad de mi Padre que los cielos, ese es mi hermano, y hermana, y madre. (Mateo 12:48-50)
    Y esta es la voluntad del Padre, el que me envio: Que de todo lo que me diere, no pierda yo nada, sino que lo resucite en el dia postrero.
    Y esta es la voluntad del que me ha enviado: Que todo aquel que ve al Hijo, y cree en el, tenga vida eterna; y yo le resucitare en el dia postrero. (John 6:39,40)
    Dijo entonces Jesus a los judios que habian creido en el: Si vosotros permaneciereis en mi palabra, sereis verdaderamente mis discipulos;
    y conocereis la verdad, y la verdad os hara libres. (John 8:31,32)
    El entonces respondiendo, les dijo: Mi madre y mis hermanos son los que oyen la palabra de Dios, y la hacen. (Lucas 8:21)
    Lo que aprendisteis y recibisteis y oisteis y visteis en mi, esto haced; y el Dios de paz estara con vosotros. (Filipenses 4:9)
    Sepa, pues, ciertisimamente toda la casa de Israel, que a este Jesus a quien vosotros crucificasteis, Dios le ha hecho Senor y Cristo.
    Al oir esto, se compungieron de corazon, y dijeron a Pedro y a los otros apostoles: Varones hermanos, їque haremos?
    Pedro les dijo: Arrepentios, y bauticese cada uno de vosotros en el nombre de Jesucristo para perdon de los pecados; y recibireis el don del Espiritu Santo.
    Porque para vosotros es la promesa, y para vuestros hijos, y para todos los que estan lejos; para cuantos el Senor nuestro Dios llamare.
    Y con otras muchas palabras testificaba y les exhortaba, diciendo: Sed salvos de esta perversa generacion. (Hechos de los apostoles 2:36-40)
    Entonces Pedro, abriendo la boca, dijo: En verdad comprendo que Dios no hace acepcion de personas,
    sino que en toda nacion se agrada del que le teme y hace justicia.
    Dios envio mensaje a los hijos de Israel, anunciando el evangelio de la paz por medio de Jesucristo; este es Senor de todos.
    Vosotros sabeis lo que se divulgo por toda Judea, comenzando desde Galilea, despues del bautismo que predico Juan:
    como Dios ungio con el Espiritu Santo y con poder a Jesus de Nazaret, y como este anduvo haciendo bienes y sanando a todos los oprimidos por el diablo, porque Dios estaba con el.
    Y nosotros somos testigos de todas las cosas que Jesus hizo en la tierra de Judea y en Jerusalen; a quien mataron colgandole en un madero.
    A este levanto Dios al tercer dia, e hizo que se manifestase;
    no a todo el pueblo, sino a los testigos que Dios habia ordenado de antemano, a nosotros que comimos y bebimos con el despues que resucito de los muertos.
    Y nos mando que predicasemos al pueblo, y testificasemos que el es el que Dios ha puesto por Juez de vivos y muertos.
    De este dan testimonio todos los profetas, que todos los que en el creyeren, recibiran perdon de pecados por su nombre. (Hechos de los apostoles 10:34-43)
    Asi que, arrepentios y convertios, para que sean borrados vuestros pecados; para que vengan de la presencia del Senor tiempos de refrigerio,
    y el envie a Jesucristo, que os fue antes anunciado… (Hechos de los apostoles 3:19,20)

    que pasara despues?
    Y sera predicado este evangelio del reino en todo el mundo, para testimonio a todas las naciones; y entonces vendra el fin. (Mateo 24:14)
    El que creyere y fuere bautizado, sera salvo; mas el que no creyere, sera condenado. (Marcos 16:16)

    La segunda venida de Jesucristo. Resurreccion de personas justas e injustas:
    los cuales tambien les dijeron: Varones galileos, їpor que estais mirando al cielo? Este mismo Jesus, que ha sido tomado de vosotros al cielo, asi vendra como le habeis visto ir al cielo. (Hechos de los apostoles 1:11)
    Entonces aparecera la senal del Hijo del Hombre en el cielo; y entonces lamentaran todas las tribus de la tierra, y veran al Hijo del Hombre viniendo sobre las nubes del cielo, con poder y gran gloria.
    Y enviara sus angeles con gran voz de trompeta, y juntaran a sus escogidos, de los cuatro vientos, desde un extremo del cielo hasta el otro. (Mateo 24:30,31)
    Porque el Senor mismo con voz de mando, con voz de arcangel, y con trompeta de Dios, descendera del cielo; y los muertos en Cristo resucitaran primero. (I Tesalonicenses 4:16)
    teniendo esperanza en Dios, la cual ellos tambien abrigan, de que ha de haber resurreccion de los muertos, asi de justos como de injustos. (Hechos de los apostoles 24:15)
    Y muchos de los que duermen en el polvo de la tierra seran despertados, unos para vida eterna, y otros para verguenza y confusion perpetua.
    Los entendidos resplandeceran como el resplandor del firmamento; y los que ensenan la justicia a la multitud, como las estrellas a perpetua eternidad. (Daniel 12:2,3)
    Y tu iras hasta el fin, y reposaras, y te levantaras para recibir tu heredad al fin de los dias. (Daniel 12:13)

    Cuando el Hijo del Hombre venga en su gloria, y todos los santos angeles con el, entonces se sentara en su trono de gloria,
    y seran reunidas delante de el todas las naciones; y apartara los unos de los otros, como aparta el pastor las ovejas de los cabritos.
    Y pondra las ovejas a su derecha, y los cabritos a su izquierda.
    Entonces el Rey dira a los de su derecha: Venid, benditos de mi Padre, heredad el reino preparado para vosotros desde la fundacion del mundo.
    Porque tuve hambre, y me disteis de comer; tuve sed, y me disteis de beber; fui forastero, y me recogisteis;
    estuve desnudo, y me cubristeis; enfermo, y me visitasteis; en la carcel, y vinisteis a mi.
    Entonces los justos le responderan diciendo: Senor, їcuando te vimos hambriento, y te sustentamos, o sediento, y te dimos de beber?
    їY cuando te vimos forastero, y te recogimos, o desnudo, y te cubrimos?
    їO cuando te vimos enfermo, o en la carcel, y vinimos a ti?
    Y respondiendo el Rey, les dira: De cierto os digo que en cuanto lo hicisteis a uno de estos mis hermanos mas pequenos, a mi lo hicisteis.
    Entonces dira tambien a los de la izquierda: Apartaos de mi, malditos, al fuego eterno preparado para el diablo y sus angeles.
    Porque tuve hambre, y no me disteis de comer; tuve sed, y no me disteis de beber;
    fui forastero, y no me recogisteis; estuve desnudo, y no me cubristeis; enfermo, y en la carcel, y no me visitasteis.
    Entonces tambien ellos le responderan diciendo: Senor, їcuando te vimos hambriento, sediento, forastero, desnudo, enfermo, o en la carcel, y no te servimos?
    Entonces les respondera diciendo: De cierto os digo que en cuanto no lo hicisteis a uno de estos mas pequenos, tampoco a mi lo hicisteis.
    E iran estos al castigo eterno, y los justos a la vida eterna. (Mateo 25:31-46)

    Entonces Pedro le dijo: Senor, їdices esta parabola a nosotros, o tambien a todos?
    Y dijo el Senor: їQuien es el mayordomo fiel y prudente al cual su senor pondra sobre su casa, para que a tiempo les de su racion?
    Bienaventurado aquel siervo al cual, cuando su senor venga, le halle haciendo asi.
    En verdad os digo que le pondra sobre todos sus bienes.
    Mas si aquel siervo dijere en su corazon: Mi senor tarda en venir; y comenzare a golpear a los criados y a las criadas, y a comer y beber y embriagarse,
    vendra el senor de aquel siervo en dia que este no espera, y a la hora que no sabe, y le castigara duramente, y le pondra con los infieles. (Lucas 12:41-46)

    Y lo que a vosotros digo, a todos lo digo: Velad. (Marcos 13:37)

    Testimonios:
    Porque no os hemos dado a conocer el poder y la venida de nuestro Senor Jesucristo siguiendo fabulas artificiosas, sino como habiendo visto con nuestros propios ojos su majestad. (II Pedro 1:16)
    Porque primeramente os he ensenado lo que asimismo recibi: Que Cristo murio por nuestros pecados, conforme a las Escrituras;
    y que fue sepultado, y que resucito al tercer dia, conforme a las Escrituras;
    y que aparecio a Cefas, y despues a los doce.
    Despues aparecio a mas de quinientos hermanos a la vez, de los cuales muchos viven aun, y otros ya duermen.
    Despues aparecio a Jacobo; despues a todos los apostoles… (I Corintios 15:3-7)
    tal como nos lo ensenaron los que desde el principio lo vieron con sus ojos, y fueron ministros de la palabra… (Lucas 1:2)

    He aqui, yo vengo pronto; reten lo que tienes, para que ninguno tome tu corona. (Apocalipsis 3:11)

    Porque No solo de pan vivira el hombre, sino de toda palabra que sale de la boca de Dios. (Mateo 4:4)

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