adminMTE_04792024-02-29T16:51:55+00:00October 20th, 2020|Categories: Clinical Trial, USA|Tags: Clinical Trial, Digital Health, FDA, Innovation, USA|
The U.S. Food and Drug Administration recently launched the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH). "The launch of the Digital Health Center of Excellence is an important step in furthering the [...]
k.janecek2024-02-29T13:56:00+00:00October 9th, 2020|Categories: Clinical Trial, Compliance, Europe, MDR, Regulatory|Tags: Clinical Trial, Europe, European Union, Regulatory|
From the 1st of October 2020, manufacturers of medical devices must register clinical investigations with the Dutch Central Committee on Research Involving Human Subjects (CCMO). The Committee will take over the tasks of the Healthcare and Youth Inspectorate (IGJ) [...]
adminMTE_04792020-09-30T14:06:33+00:00September 30th, 2020|Categories: Clinical Trial, Europe, Innovation, Software|Tags: Clinical Trial, Digital Health, EMA, Europe, Innovation|
Digital health technologies are becoming increasingly relevant for the conduct of clinical trials. As a demonstration, the European Medicine Agency (EMA) recently established an Innovation Task Force, "a multidisciplinary group that includes scientific, regulatory and legal competences [...] to provide [...]
k.janecek2024-02-01T16:41:27+00:00September 29th, 2020|Categories: Clinical Trial, Covid-19, Regulatory|Tags: Canada, Clinical Trial, Covid-19, Regulatory|
Health Canada published two guidance documents aimed at improving clinical trials for medical devices and medicines during the COVID-19 pandemic. New trialsTo reduce regulatory burden, Health Canada has developed a new regulatory pathway, the interim order for clinical trials for medical [...]
adminMTE_04792024-02-29T17:09:11+00:00September 29th, 2020|Categories: Clinical Trial, Covid-19, Regulatory, USA|Tags: Clinical Trial, Covid-19, FDA, Regulatory, USA|
FDA provided an update to the guidance on the conduct of clinical trials during COVID-19 pandemic. The update aims at providing "general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice [...]
adminMTE_04792024-02-29T16:50:47+00:00September 25th, 2020|Categories: Clinical Trial, Compliance, Regulatory, USA|Tags: FDA, Regulatory, USA|
The U.S. Food and Drug Administration (FDA) has issued a guidance document on the use of ISO 10993-1 in the assessment of medical devices that come in direct or indirect contact with the human body. The standard is recognized [...]
adminMTE_04792024-02-29T16:38:59+00:00September 3rd, 2020|Categories: Clinical Trial, Compliance, Regulatory, Software, USA|Tags: Clinical Trial, Digital Health, FDA, Regulatory, USA|
The FDA issued a guidance for the selection of patient-reported outcome (PRO) instruments in clinical evaluation of their products. The guidance details such topics as modification or adaptation of existing PRO instruments as well as the possibility of including [...]
adminMTE_04792024-02-29T16:58:13+00:00August 17th, 2020|Categories: Clinical Trial, Compliance, USA|Tags: FDA, Regulatory, USA|
The FDA issued the first two device-specific guidances drawing performance criteria to support 510(k) clearance via the new pathway. The FDA had previously proposed an alternate safety and performance based pathway for certain well-understood medical devices. The two final [...]
adminMTE_04792024-02-29T16:01:48+00:00August 14th, 2020|Categories: Clinical Trial, Covid-19, UK|Tags: Clinical Trial, Covid-19, MHRA, UK|
MHRA issued a guidance including the plan to resume on-site inspections next September and scale up to full on-site inspection program in October 2020. Onsite inspections in the UK halted in March due to the COVID-19 pandemic. If you [...]
adminMTE_04792024-02-29T17:10:45+00:00August 13th, 2020|Categories: Clinical Trial, Compliance, Covid-19, USA|Tags: Clinical Trial, Covid-19, FDA, USA|
The Food and Drug Administration has published two new webpages with instructions on medical device importation, registration and listing amid COVID-19. Meditrial is there to help! - Reach out to us for any kind of assistance in regard of [...]
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