Regulation of Medical Devices for Dermatology.

Dermatology Device Approval Humans Medical Device Legislation United States United States Food and Drug Administration
Chronic wound Dermal filler Energy-based device Laser Light-based device Medical device Soft tissue filler Wound care product

Journal

Dermatologic clinics
ISSN: 1558-0520
Titre abrégé: Dermatol Clin
Pays: United States
ID NLM: 8300886

Informations de publication

Date de publication:
Jul 2022
Historique:
entrez: 24 6 2022
pubmed: 25 6 2022
medline: 29 6 2022
Statut: ppublish

Résumé

Medical devices became subject to the current framework of regulation and premarket review by the Food and Drug Administration (FDA) in 1976. Devices are distinguished from drugs by the means in which they achieve their primary intended purposes. All medical devices, regardless of risk, share certain regulatory requirements to assure quality, safety, and transparency. Moderate- to high-risk devices must additionally be cleared or approved by FDA before being introduced into interstate commerce. Dermatologic devices regulated by FDA range from high-power energy-based devices to wound dressings, and from complex electronic devices to topically applied barrier creams.

Identifiants

DOI: 10.1016/j.det.2022.02.005 PMID: 35750413
pubmed: 35750413
pii: S0733-8635(22)00007-9
doi: 10.1016/j.det.2022.02.005
pii:
doi:

Types de publication

Journal Article Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

297-305

Informations de copyright

Published by Elsevier Inc.

Auteurs

Shlomit Halachmi (S)

Center for Devices and Radiological Health, US Food and Drug Administration, White Oak Building 66, Room 4529, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA. Electronic address: shlomit.halachmi@fda.hhs.gov.

Laura Marquart (L)

Center for Devices and Radiological Health, US Food and Drug Administration, White Oak Building 66, Room 4556, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.

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Classifications MeSH

questionsmedicales.fr › Professions de santé › Médecine › Dermatologie › Regulation of Medical Devices for Dermatology.
questionsmedicales.fr › Environnement et santé publique › Santé publique › Sécurité des produits de consommation › Agrément de dispositif › Regulation of Medical Devices for Dermatology.
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Regulation of Medical Devices for Dermatology.
questionsmedicales.fr › Organisations et économie des soins de santé › Contrôle social formel › Législation comme sujet › Législation médicale › Législation sur les dispositifs médicaux › Regulation of Medical Devices for Dermatology.
questionsmedicales.fr › Régions géographiques › Amériques › Amérique du Nord › États-Unis › Regulation of Medical Devices for Dermatology.
questionsmedicales.fr › Organisations et économie des soins de santé › Organismes › Gouvernement › Agences gouvernementale américaines › Department of Health and Human Services (USA) › Public Health Service (USA) › Food and Drug Administration (USA) › Regulation of Medical Devices for Dermatology.