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_04792024-02-02T11:58:44+00:00July 13th, 2020|Categories: Clinical Trial, Compliance, Europe|Tags: Clinical Trial, Europe, European Commission, USA|
The European Commission together with the European regulatory agencies EMA (European Medicines Agency) and HMA (Heads of Medicine), released a statement to urge sponsors to comply with clinical trials rules after Brexit. The deadline for compliance is 31st December [...]
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.janecek2024-02-29T17:02:19+00:00June 29th, 2020|Categories: Clinical Trial, Compliance, Regulatory, USA|Tags: Clinical Trial, FDA, Regulatory, USA|
The Food and Drug Administration (FDA) issued guidance on inspections of medical device establishments. The finalized document follows draft guidance issued on March 28, 2019, filling a requirement of the FDA Reauthorization Act of 2017 (FDARA). The guidance specifies [...]
adminMTE_04792024-02-29T17:05:07+00:00June 24th, 2020|Categories: Clinical Trial, Covid-19, Regulatory, USA|Tags: Clinical Trial, Covid-19, FDA, Regulatory, USA|
FDA published a Q&A document to respond frequently asked questions from submitters and applicants on regulatory matters and issues relating to medical devices arising from the COVID-19 public health emergency. This guidance addresses the following: Meetings with Industry MDUFA [...]
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