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 [...]
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_04792024-02-29T17:10:45+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 [...]
adminMTE_04792024-02-29T16:48:12+00:00July 29th, 2020|Categories: Clinical Trial, Software, USA|Tags: FDA, USA|
The FDA finalized a guidance for sponsors regarding the FDA´s review of medical products that contain both medical and non-medical functions. Meditrial has extensive experience with assisting sponsors in regard of FDA requirements for medical devices and software as [...]
adminMTE_04792024-02-29T16:40:22+00:00July 23rd, 2020|Categories: Clinical Trial, Compliance, USA|Tags: Covid-19, FDA, USA|
The FDA ordered the exemption five types of Class II medical devices from 510(k) requirements. This decision aims at releaving manufacturers of those devices from some regulatory burden. Meditrial has extensive experience on regulatory matters relating to medical device [...]
adminMTE_04792024-02-29T16:53:39+00:00July 13th, 2020|Categories: Clinical Trial, Covid-19, USA|Tags: Clinical Trial, Covid-19, FDA, USA|
The Food and Drug Administration (FDA) announced the plan to resume on-site domestic inspections beginning the week of 20 July 2020. The resume process will be different in each state according to local rules and epidemiological situation. Moreovoer, a [...]
k.janecek2024-02-29T14:46:51+00:00July 1st, 2020|Categories: Compliance, Covid-19, Regulatory, USA|Tags: Covid-19, FDA, Regulatory|
The US Food and Drug Administration (FDA) has published final guidance for unique device identification compliance dates for Class I and Unclassified Medical Devices. This immediately in effect guidance also clarifies the Agency policy concerning compliance dates for certain [...]
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