adminMTE_04792024-02-26T09:10:23+00:00May 25th, 2020|Categories: Clinical Trial, Compliance, Covid-19, USA|Tags: Clinical Trial, Covid-19, FDA, Regulatory, USA|
The US Food and Drug Administration (FDA) issued a guidance with immediate effect which allows medical device manufacturers to make “limited modifications” to their devices without submitting a premarket approval (PMA), humanitarian device exemption (HDE) supplement or a 30-day [...]
k.janecek2024-02-07T16:16:06+00:00May 18th, 2020|Categories: Clinical Trial, Covid-19, Regulatory, USA|Tags: Clinical Trial, Covid-19, FDA, Regulatory, USA|
FDA issued a guidance to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity for the duration of the COVID-19 emergency. FDA [...]
adminMTE_04792024-02-26T09:43:11+00:00May 13th, 2020|Categories: Clinical Trial, Covid-19, Regulatory, USA|Tags: Clinical Trial, Covid-19, FDA, USA|
FDA published the guidance to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice(GCP), and minimizing risks to trial integrity for the duration of the COVID-19 public health emergency. [...]
adminMTE_04792024-02-26T09:44:34+00:00May 13th, 2020|Categories: Clinical Trial, Regulatory, USA|Tags: Clinical Trial, Covid-19, FDA, Regulatory, USA|
The FDA is collaborating with the CDC to develop a process that would govern how and where to return to on-site facility surveillance inspections in accordance with the gating criteria outlined in the White House Guidelines for Opening Up [...]
k.janecek2024-02-29T13:59:58+00:00May 1st, 2020|Categories: Covid-19, Europe, USA|Tags: Covid-19, Europe, Helpline, USA|
By Dr. Monica Tocchi, MD, PhD One million Covid-19 patients have returned to their homes after discharge from hospital. But are they fully healed? Why is this not being discussed amidst the crisis? It is a burning global health [...]
k.janecek2024-02-29T14:08:24+00:00April 30th, 2020|Categories: Covid-19, Europe, Regulatory, USA|Tags: Covid-19, Europe, Regulatory, USA|
Both the European and the United States regulatory authorities have issued multiple guidances in response to the COVID-19 emergency, in order to ease the burden on the healthcare system and facilitate the production and import of needed devices during [...]
k.janecek2024-02-07T16:09:22+00:00April 28th, 2020|Categories: Covid-19, USA|Tags: Covid-19, FDA, USA|
The FDA developed a fact sheet in collaboration with the Centers for Disease Control and Prevention (CDC) to help answer questions from the food and agriculture sector about what respirators, disposable face masks, such as surgical or medical masks, or [...]
adminMTE_04792024-02-23T16:59:16+00:00April 27th, 2020|Categories: Compliance, USA|Tags: Covid-19, Digital Health, FDA, USA|
FDA issued guidances to provide a policy to help expand the availability of devices for remote reviewing and reporting of scanned digital images of pathology slides and non-invasive fetal and maternal monitoring devices during COVID-19 pandemic. Enforcement Policy for [...]
adminMTE_04792024-02-26T11:42:11+00:00April 24th, 2020|Categories: Compliance, Europe, Innovation, Regulatory, Software, USA|Tags: Clinical Trial, Europe, IMDRF, Regulatory, USA|
The International Medical Device Regulators Forum (IMDRF) issued on April 20th four technical documents covering cybersecurity, personalized devices, conformity assessment bodies and terminologies for categorized Adverse Event Reporting (AER). Following, a short overview on the content of the guidelines: [...]
adminMTE_04792024-02-26T10:57:19+00:00April 21st, 2020|Categories: Compliance, Covid-19, Regulatory, USA|Tags: Covid-19, FDA, USA|
FDA issued indications for medical device manufacturers within the CARES Act: Coronavirus Aid, Relief, and Economic Security Act. General provisions Medical device manufacturers are now required to report permanent discontinuance or interruption in manufacturing for the following categories of [...]
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