US FDA Reactions to mitigate pandemic impact on industry and the public
While global markets are being impacted by COVID-19 pandemic, FDA issues various statements regarding measures to tackle the negative impact on industry and people. Following, we provide a summary of FDA recently introduced regulatory policies.
- March 31
The FDA has added a new program to enable the development of potentially safe and effective life-saving methods. This program, known as the Coronavirus Treatment Acceleration Program (CTAP), uses all the tools the Agency has to enable new therapies to be delivered to sick patients, and then control the test results to assess whether these remedies are safe and effective for treating patients infected with this novel virus.
Read more about Coronavirus (COVID-19) Update: FDA Continues to Accelerate Development of Novel Therapies for COVID-19
- March 18
– FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections: Domestic routine surveillance facility inspections are postponed, as well as foreign inspections through April 2020. The FDA is evaluating additional ways to conduct for-cause inspections including, among other things, evaluating records in lieu of conducting an onsite inspection.
– FDA Issues Guidance for Conducting Clinical Trials: The FDA issued a guidance for industry, investigators, and institutional review boards conducting clinical trials during the COVID-19 pandemic. The guidance provides considerations to assist sponsors in securing the safety of trial participants, maintaining compliance with good clinical practice and minimizing risks to trial integrity. Sponsors are recommended to evaluate alternative methods for assessments, like phone contacts or virtual visits.
- March 17 – FDA Issues Temporary Policy for FSMA Onsite Audit Requirements: The FDA issued a temporary policy for Food Safety Modernization Act (FSMA) supplier verification onsite audit requirements to help prevent disruptions in the food supply-chain during the COVID-19 pandemic.
- March 16 – FDA Provides More Regulatory Relief During Outbreak, Continues to Help Expedite Availability of Diagnostics: The FDA issued a guidanceto stimulate diagnostic development taking into account the urgency caused by COVID-19. The guidance provides instructions for test developers who wish to develop serological tests and includes a policy for states to take responsibility for tests developed and used by laboratories in their states. Moreover, under certain circumstances, it announces enforcement discretion towards commercial manufacturers distributing and labs using new commercially developed tests prior to the FDA granting an emergency use authorization.
- March 9 – FDA and FTC Warn Seven Companies Selling Fraudulent Products that Claim to Treat or Prevent COVID-19: The FDA and the Federal Trade Commission (FTC) notified seven companies with warning letters for selling unapproved drugs for COVID-19 posing significant risks to patient health and violating federal law.
- February 27 – Supply Chain Update: The FDA announced initiatives to help limiting potential disruptions to supply or shortages of medical products in the U.S. Certain manufacturers of medical products have been asked to evaluate their supply chain and communicating potential disruptions. Among others, the announcement establishes reporting requirements for device manufacturers.
Table of Contents
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Practical guidance on the CE mark for medical devices under EU MDR, from classification and evidence to conformity assessment and EUDAMED
A Practical RBQM Framework for Medical Device Trials
Risk-based quality management for medical device trials, with practical actions for risk assessment, monitoring, data review, and trial oversight
EU Breakthrough Medical Devices Under MDCG 2025-9 (BtX)
EU breakthrough medical devices gain a clearer regulatory pathway under MDCG 2025-9, with early advice and lifecycle evidence planning
What Swissmedic Fast-Track Means for Clinical Trial Sponsors
Swissmedic swissethics Fast-Track Pilot Project accelerates eligible trial reviews and makes coordinated regulatory preparation increasingly important.
FDA Breakthrough Device Acceleration
How innovative MedTech companies can accelerate FDA approval, secure Medicare coverage, and reach patients faster—starting with Breakthrough Device Designation.
The contribution of patient associations in clinical trials
Historically, patient organizations have had the primary purpose of supporting the communities they represented. Today, this remains a crucial function, but modes have changed, as has the role that associations and patients themselves take on [...]
This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
