k.janecek2023-03-29T14:04:09+00:00March 3rd, 2022|Categories: Clinical Trial, Compliance, FDA, Regulatory, USA|Tags: CDRH, Clinical Trial, Compliance, FDA, Medical Devices, MedTech, Regulatory, Regulatory Affairs, USA|
The FDA published a guidance on Center for Devices and Radiological Health (CDRH) Appeals Processes. The document describes the processes available to external stakeholders to request additional review of CDRH employees’ decisions or actions. It is intended only to [...]
k.janecek2023-03-29T14:06:37+00:00February 8th, 2022|Categories: Compliance, FDA, Regulatory, USA|Tags: 510K, Compliance, FDA, medicines, MedTech, Regulatory Affairs, USA|
The FDA has finalized guidance on the use of premarket pathways for combination products. The document defines combination products, the coordination between the FDA and sponsors, and recommendations on how to determine the types of premarket submissions for a [...]
k.janecek2023-03-29T14:26:12+00:00February 1st, 2022|Categories: Clinical Trial, Compliance, FDA, Regulatory, USA|Tags: Clinical Trial, FDA, Regulatory, USA|
The US Food and Drug Administration (FDA) has published a new guidance for industry: Good ANDA Submission Practices. "This guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs). This guidance highlights common, [...]
adminMTE_04792023-03-29T15:49:17+00:00November 4th, 2021|Categories: Various|Tags: 510K, BLA, denovo, Device Software, FDA, HDE, IDE, Medical Devices, PMA, SaMD, SiMD|
FDA issued a draft guidance that identifies the software information generally necessary for evaluating the safety and effectiveness of a device in a premarket submission. This document is intended to cover: ▪️ firmware and other means for software-based control of medical [...]
Elena Trombettoni2023-03-29T15:52:58+00:00September 30th, 2021|Categories: Digital Health, FDA, Innovation, Software|Tags: 510K, eSubmission, FDA|
On September 28th, FDA published draft Guidance on the ''Electronic Submission Template for medical device 510k Submissions'', which will remain open for public consultation for 60 days. The Guidance introduces the electronic Submission Template and Resource tool eSTAR, which [...]
k.janecek2023-03-29T15:53:12+00:00September 16th, 2021|Categories: Clinical Trial, Compliance, Europe, FDA, Innovation, Regulatory|Tags: Clinical Trial, Complex Generic Drugs, DRUGS, EMA, Europe, European Union, FDA, Generic Drug, Hybrid Medicines, Innovation, medicines, PSA, Regulatory, USA|
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) launched a new pilot program to provide parallel scientific advice (PSA) to sponsors of complex generic drugs, or hybrid medicines, as they are called in the [...]
adminMTE_04792023-04-21T09:12:50+00:00March 19th, 2021|Categories: Clinical Trial, USA|Tags: Clinical Trial, Digital Health, FDA, RWE, USA|
The FDA issued a document reporting examples of real world evidence (RWE) application to support marketing applications for medical devices. The document includes examples of RWE in several submission types: premarket notification 510(k) , De Novo, humanitarian device exemption (HDE), [...]
adminMTE_04792023-04-21T10:48:30+00:00January 29th, 2021|Categories: Regulatory, USA|Tags: ASCA, CDRH, Conformity Assessment, FDA, USA|
The US Food and Drug Administration (FDA)’s Center for Devices and Radiological Health (CDRH) annouced the full launch of a pilot conformity assessment program in 2021. Contact Meditrial to know about our strategic assessments of regulatory requirements to address business [...]
adminMTE_04792023-04-21T11:21:20+00:00January 19th, 2021|Categories: Compliance, Innovation, Software, USA|Tags: AI, Artificial Intelligence, Digital Health, FDA, Machine Learning, Regulatory, SaMD, Software|
The FDA has released an action plan to develop a regulatory framework on artificial intelligence/machine learning (AI/ML)-based software as a medical device (SaMD). The FDA aims to publish the draft guidance this year. As a Digital Research Organization, Meditrial understands [...]
adminMTE_04792023-04-21T13:57:33+00:00October 22nd, 2020|Categories: Clinical Trial, Regulatory, USA|Tags: Clinical Trial, FDA, Regulatory, USA|
The FDA introduced a new Medical Device Development Tools (MDDT) for the investigation of medical devices. Through the MDDT program, the FDA defines tools that medical device sponsors can use in the development and evaluation of medical devices. The newly [...]
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