المؤلفون: Colin M. Pollard

المصدر: Frontiers in Reproductive Health, Vol 5 (2023)

مصطلحات موضوعية: menstrual tampons, vaginal pessaries, medical device, regulation, food and drug administration, 510(k) premarket notification, Reproduction, QH471-489, Medicine (General), R5-920

وصف الملف: electronic resource

العلاقة: https://www.frontiersin.org/articles/10.3389/frph.2023.1224421/fullTest; https://doaj.org/toc/2673-3153Test

الوصول الحر: https://doaj.org/article/299717b4ef2d48489af7e1e6cf61f301Test

المؤلفون: Aashka Shah, Michelle M. Olson, Joseph M. Maurice

المصدر: Surgery in Practice and Science, Vol 12, Iss , Pp 100158- (2023)

مصطلحات موضوعية: FDA device approval, FDA device recall, 510(k) pathway, Premarket approval process, General surgery, Plastic surgery, Surgery, RD1-811

وصف الملف: electronic resource

العلاقة: http://www.sciencedirect.com/science/article/pii/S2666262023000049Test; https://doaj.org/toc/2666-2620Test

الوصول الحر: https://doaj.org/article/ebec13a0f3f74fcabe93903251cc4c55Test

المؤلفون: M. R. Karimi Estahbanati

المصدر: Microorganisms, Vol 11, Iss 10, p 2566 (2023)

مصطلحات موضوعية: sterilizer, 510(k), sterilant, medical device, VHP, Biology (General), QH301-705.5

وصف الملف: electronic resource

العلاقة: https://www.mdpi.com/2076-2607/11/10/2566Test; https://doaj.org/toc/2076-2607Test

الوصول الحر: https://doaj.org/article/e19ec8ad212c4057b3c37873ce4f221dTest

المؤلفون: Seth, Divya, Wang, Sophie, Ezaldein, Harib H, Merati, Miesha, Scott, Jeffrey F

المصدر: Dermatology Online Journal. 25(1)

مصطلحات موضوعية: acne, light therapy, FDA approval, 510(k), Google Trends

وصف الملف: application/pdf

الوصول الحر: https://escholarship.org/uc/item/8sq5j6vkTest

المؤلفون: Katru, Sujatha¹, Majety, Raga Padmasri Deepika, Veluchuri, Jaya Prakash, Yallabandi, Sita Priya Darsini, Juturi, Ravi Kumar Reddy

المصدر: International Journal of Drug Regulatory Affairs 8(3):11-21. 2020

المؤلفون: Albert P. Manudhane, Sophie Wang, Harib H. Ezaldein, Jeffrey F. Scott

المصدر: Journal of Dermatological Treatment, Vol 31, Iss 2, Pp 200-203 (2020)

مصطلحات موضوعية: muscle conditioning, muscle toning, pain relief, muscle blood flow, 510(k), maude, premarket approval, abdominal muscles, slendertone, transcutaneous electrical muscle stimulation, Dermatology, RL1-803

وصف الملف: electronic resource

العلاقة: https://doaj.org/toc/0954-6634Test; https://doaj.org/toc/1471-1753Test

الوصول الحر: https://doaj.org/article/cf52dc6b0de2437497207ec38d5334f4Test

المؤلفون: George, Bobby¹

المصدر: International Journal of Drug Regulatory Affairs (IJDRA) 7(2):62-66. 2019

المؤلفون: Santhosh, S.¹, Kamaraj, R.

المصدر: Research Journal of Pharmacy and Technology 11(12):5675-5780. 2018

المؤلفون: Gerke, Sara

المصدر: Faculty Scholarly Works

مصطلحات موضوعية: Artificial intelligence, machine learning, medical devices, FDA law, safety and effectiveness, clinical decision support software, 510(k), Pre-Cert Program, black-box AI/ML models, clinical trials, adaptive algorithms, update problem, system view, Law, Medical Jurisprudence, Science and Technology Law

وصف الملف: application/pdf

العلاقة: https://ideas.dickinsonlaw.psu.edu/fac-works/284Test; https://ideas.dickinsonlaw.psu.edu/context/fac-works/article/1286/viewcontent/SSRN_id4070947__1_.pdfTest

الإتاحة: https://ideas.dickinsonlaw.psu.edu/fac-works/284Test
https://ideas.dickinsonlaw.psu.edu/context/fac-works/article/1286/viewcontent/SSRN_id4070947__1_.pdfTest

المؤلفون: Sophie Wang, Divya Seth, Harib Ezaldein, Raghav Tripathi, Miesha Merati, Fuad Muakkassa, Jeffrey Scott

المصدر: Journal of Dermatological Treatment, Vol 30, Iss 5, Pp 489-491 (2019)

مصطلحات موضوعية: androgenetic alopecia, low-level laser therapy, hair loss, hair growth, 510(k), Dermatology, RL1-803

وصف الملف: electronic resource

العلاقة: https://doaj.org/toc/0954-6634Test; https://doaj.org/toc/1471-1753Test

الوصول الحر: https://doaj.org/article/f10a4b65503d427da536f0b2abaa15ceTest