POSTED AUGUST 12, 2020
What is FDA doing to to help expand the availability and capability of non-invasive remote monitoring devices to facilitate patient monitoring while reducing patient and healthcare provider exposure to COVID-19? In this episode, David discusses the June 2020 Guidance Document: “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised)”.
POSTED AUGUST 19, 2020
The COVID-19 public health emergency and response effort support has been a top priority for FDA, and this has impacted the agency’s normal operations and performance timelines. In this episode, David covers the June 2020 Guidance Document: “Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices – Questions and Answers.”
POSTED AUGUST 27, 2020
The COVID-19 pandemic has impacted clinical development and the status of ongoing trials across many investigational product areas. In this episode, David discusses the June 2020 FDA Guidance Document: “Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency.”
POSTED SEPTEMBER 1, 2020
FDA recently issued revised and updated guidance to help expand the availability of various face masks and respirators, in support of COVID-19 pandemic response efforts. In this episode, David discusses the May 2020 Guidance Document: “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised).”
POSTED SEPTEMBER 3, 2020
FDA has issued revised guidance to assist manufacturers in notifying the agency about a permanent discontinuance or an interruption in the production of specific medical devices, so that FDA can prevent or mitigate shortages during the COVID-19 public health emergency. In this episode, David discusses the June 2020 Guidance Document: “Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency (Revised).”
POSTED SEPTEMBER 15, 2020
FDA has issued guidance to help facilitate the availability of devices for use in transporting certain clinical specimens, and therefore expand the availability of critical SARS-CoV-2 diagnostic testing in the U.S., for the duration of the COVID-19 public health emergency. In this episode, David details the July 2020 Guidance Document: “Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.”
POSTED SEPTEMBER 29, 2020
FDA has provided updated guidance to assist medical device sponsors, clinical Investigators, and Institutional Review Boards in assuring the safety of trial participants, maintaining compliance with good clinical practice, and minimizing risks to trial integrity for the duration of the COVID-19 public health emergency. In this episode, David discusses FDA’s Guidance document, “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency” (issued March 2020, updated September 21, 2020).
POSTED OCTOBER 14, 2020
In this episode of "FDA Guidance Review," David overviews FDA’s Guidance document, “Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency,” published in May 2020. FDA’s intent with this Guidance is to help foster the continued availability of medical devices during the COVID-19 public health emergency while being flexible regarding limited modifications made to devices that are subject to FDA review, through either a PMA/HDE supplement or 30-day notice.
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