US: FDA guidance on CDRH Appeals Processes

2023-03-29T14:04:09+00:00March 3rd, 2022|Categories: Clinical Trial, Compliance, FDA, Regulatory, USA|Tags: , , , , , , , , |

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 [...]

FDA Finalizes Guidance for Premarket Pathways for Combination Products

2023-03-29T14:06:37+00:00February 8th, 2022|Categories: Compliance, FDA, Regulatory, USA|Tags: , , , , , , |

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 [...]

New FDA guidance: Good ANDA Submission Practices

2023-03-29T14:26:12+00:00February 1st, 2022|Categories: Clinical Trial, Compliance, FDA, Regulatory, USA|Tags: , , , |

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, [...]

Content of Premarket Submission for Device Software Functions

2023-03-29T15:49:17+00:00November 4th, 2021|Categories: Various|Tags: , , , , , , , , , , |

FDA issued a draft guidance that identifies the software information generally necessary for evaluating the safety and effectiveness of a device in a premarket submission.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 [...]

Electronic Submission Template for Medical Device 510(k) Submissions

2023-03-29T15:52:58+00:00September 30th, 2021|Categories: Digital Health, FDA, Innovation, Software|Tags: , , |

On September 28th, FDA published draft Guidance on the ''Electronic Submission Template for medical device 510k Submissions'', which will remain open for public consultation for 60 days.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 [...]

FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Products

2023-03-29T15:53:12+00:00September 16th, 2021|Categories: Clinical Trial, Compliance, Europe, FDA, Innovation, Regulatory|Tags: , , , , , , , , , , , , , |

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 [...]

US: FDA provides examples on real world evidence to support marketing applications for medical devices

2023-04-21T09:12:50+00:00March 19th, 2021|Categories: Clinical Trial, USA|Tags: , , , , |

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), [...]

US: CDRH plans full launch of ASCA pilot program in 2021

2023-04-21T10:48:30+00:00January 29th, 2021|Categories: Regulatory, USA|Tags: , , , , |

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 [...]

US: FDA Releases Artificial Intelligence/Machine Learning Action Plan

2023-04-21T11:21:20+00:00January 19th, 2021|Categories: Compliance, Innovation, Software, USA|Tags: , , , , , , , |

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 [...]

US: FDA introduces new Medical Device Development Tools for sponsors

2023-04-21T13:57:33+00:00October 22nd, 2020|Categories: Clinical Trial, Regulatory, USA|Tags: , , , |

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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