Patient Access To Medical Devices

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New Program with Payors Aims to Accelerate Patient …

https://www.fda.gov/news-events/fda-voices/new-program-payors-aims-accelerate-patient-access-medical-devices

The FDA believes that early engagement with manufacturers and payors during the planning phase of medical device clinical trials will expedite patient access to high quality, safe, and effective ...

Medical devices - World Health Organization

https://www.who.int/health-topics/medical-devices

Policies, strategies, and action plans for health technologies, specifically for medical devices, are required in any national health plan. Within the context of a robust …

Patient Access to Medical Devices — A …

https://www.nejm.org/doi/full/10.1056/NEJMp1204170

Perspective from The New England Journal of Medicine — Patient Access to Medical Devices — A …

Wireless Medical Devices | FDA

https://www.fda.gov/medical-devices/digital-health-center-excellence/wireless-medical-devices

Benefits and Risks. Incorporation of wireless technology in medical devices can have many benefits, including increasing patient mobility by eliminating wires that tether a patient to …

New program with payors aims to accelerate patient access to …

https://www.todaysmedicaldevelopments.com/news/fda-medical-device-access-9818/

The FDA believes that early engagement with manufacturers and payors during the planning phase of medical device clinical trials will expedite patient access …

Expanded Access for Medical Devices | FDA

https://www.fda.gov/medical-devices/investigational-device-exemption-ide/expanded-access-medical-devices

Expanded access is a potential pathway for patients with a serious or life-threatening disease or condition to access an investigational medical device that has …

Barriers and facilitators of patient access to medical devices in ...

https://www.sciencedirect.com/science/article/pii/S0168851019302362

In the EU, market access to MDs has been governed by EU Directive 2007/47/EC (as amended) relating to MDs and active implantable medical devices (AIMDs), and Directive 98/79/EC concerning in vitro diagnostics [].These directives were implemented into national legislation and specified requirements at an EU level for the …

Patient Access to Medical Devices | NEJM

https://www.nejm.org/doi/full/10.1056/NEJMc1211381

Patient Access to Medical Devices. To the Editor: In their Perspective article, Basu and Hassenplug (Aug. 9 issue) 1 claim that the time required for patients to …

Barriers and facilitators of patient access to medical …

https://pubmed.ncbi.nlm.nih.gov/31718855/

A large number of medical devices (MDs) is available in Europe. Procedures for market approval and reimbursement have been adopted over recent years to promote …

Patient access to medical devices--a comparison of U.S.

https://pubmed.ncbi.nlm.nih.gov/22852882/

Patient access to medical devices--a comparison of U.S. and European review processes. Patient access to medical devices--a comparison of U.S. and …

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