News | Radiology Imaging | February 25, 2020

Coronavirus Update from the FDA

Steps the FDA is taking to ensure quality of foreign products

Images in a 41-year-old woman who presented with fever and positive polymerase chain reaction assay for the 2019 novel coronavirus (2019-nCoV) #coronavirus #nCoV2019 #2019nCoV #COVID19

Images in a 41-year-old woman who presented with fever and positive polymerase chain reaction assay for the 2019 novel coronavirus (2019-nCoV). Three representative axial thin-section chest CT images show multifocal ground glass opacities without consolidation. Three-dimensional volume-rendered reconstruction shows the distribution of the ground-glass opacities (arrows). Image courtesy of the Radiological Society of North America (RSNA)

February 24, 2020 — The U.S. Food and Drug Administration (FDA) gave an update on its activities regarding the novel coronvirus (COVID-19), which are focused on efforts to facilitate diagnose, treat and prevent the disease. The agency is also surveilling the medical product supply chain for potential shortages or disruptions and helping to mitigate impacts.

The FDA is not currently conducting inspections in China in response to the U.S. Department of State’s Travel Advisory to not travel to China due to the novel coronavirus outbreak. The FDA pulled its inspectors back to the U.S., but said when the travel advisory is changed, the agency will resume routine inspections as soon as feasible.

The FDA issued a new statement from Stephen M. Hahn, M.D., commissioner of food and drugs, U.S. Food and Drug and Administration, and Judith A. McMeekin, Pharm.D., associate commissioner for regulatory affairs, Office of Regulatory Affairs, regarding steps the FDA is taking to ensure quality of foreign products during the coronavirus (COVID-19) outbreak.

"We continue to take a multi-pronged approach to this public health emergency, including focusing on actively facilitating efforts to diagnose, treat and prevent the disease; surveilling the medical product supply chain for potential shortages or disruptions and helping to mitigate such impacts, as necessary; and leveraging the full breadth of our public health tools, including enforcement tools to stop fraudulent activity as we oversee the safety and quality of FDA-regulated products for American patients and consumers," the agency leaders said in the statement. 

 

Coronavirus Disrupts FDA Inspections in China

The FDA oversight inspections of imported products from China have been impacted by the COVID-19 outbreak and, the officials said. However, they said the agency is still making efforts to ensure product safety.

"While we are not able to conduct inspections in China right now, this is not hindering our efforts to monitor medical products and food safety. We have additional tools we are utilizing to monitor the safety of products from China, and in the meantime, we continue monitoring the global drug supply chain by prioritizing risk-based inspections in other parts of the world," according to the statement. The FDA  said it will resume routine inspections in China as soon as possible after the lift of the travel ban.

"We already use other tools to help complement our inspections, including import screening, examinations, sampling, and import alerts, relying on a firm’s previous compliance history, and we use information from foreign governments as part of mutual recognition agreements. Thus, at this time, we can rely on these other tools to give us comprehensive oversight of FDA-regulated products entering this country," the FDA stated. This is all part of the agency’s risk-based approach to ensuring quality, as well as compliance with applicable FDA requirements.

A wide variety of FDA-regulated products are imported from China, which makes it important to assure the public of the quality of these products. At this time, the agency said over 60% of FDA-regulated products imported from China are medical devices and 20% are housewares (like food packaging).  In response to the COVID-19 outbreak, the FDA will utilize its authority to request records from firms “in advance or in lieu of” drug surveillance inspections in China.

The Federal Food, Drug, and Cosmetic Act, as amended by the FDA Safety and Innovation Act (FDASIA) of 2012, gives the FDA authority to request records “in advance of or in lieu of” on-site drug inspections. Congress enacted this provision to improve the effectiveness and efficiency of inspections, given the increasing globalization of drug production.  Along with other FDASIA provisions, this inspection record request authority was viewed as a way to “level the playing field” between foreign and domestic drug inspections by allowing the FDA to review records ahead of time and take a more risk-based approach to conducting both domestic and foreign inspections. These records will help the agency when it resume drug inspections in China.

"By applying the use of paper records in our risk-based inspection framework, we can prioritize our early inspections on those deemed most needed, based on the records. By doing so, we hope to rapidly assess what could become a backlog number of on-the-ground surveillance inspections this fiscal year if travel restrictions persist," the FDA stated.

In addition to records requests, the FDA will continue working with U.S. Customs and Border Protection to target products intended for importation into the U.S. that violate applicable legal requirements for FDA-regulated products, which may come from a variety of sources, such as first time importers unfamiliar with regulatory requirements or repeat offenders trying to skirt the law. FDA has the ability through the risk-based import screening tool (PREDICT) to focus examinations and sample collections based on heightened concerns of specific products being entered into U.S. commerce. The PREDICT screening continues to adjust risk scores as necessary throughout the COVID-19 outbreak.  

"We are keeping a close eye out for indications of port shopping or cargo diversion and will continue our oversight of shipments through potentially higher-risk venues such as international mail facilities. We can refuse admission of products that fail sample testing or may violate other applicable legal requirements," The FDA said.

 

No Evidence of Coronavirus Being Transmitted via Products Shipped From China

The FDA officials said they are are not seeing the impacts of the coronavirus outbreak resulting in an increased public health risk for American consumers from imported products from China.

"There is no evidence to support transmission of COVID-19 associated with imported goods and there have not been any cases of COVID-19 in the United States associated with imported goods," the FDA said in the statement.  This remains a dynamic situation and the FDA said it will continue to assess nd update guidance as needed. 

 

FDA Monitors Bogus Drugs and Cures for Coronavirus

"We also continue to aggressively monitor the market for any firms marketing products with fraudulent COVID-19 prevention and treatment claims," the FDA said. 

The agency said it can and will use every authority at our disposal to protect consumers from bad actors who would take advantage of a crisis to deceive the public, including pursuing warning letters, seizures, or injunctions against products on the market that are not in compliance with the law, or against firms or individuals who violate the law.

 

Additional References on the Novel Coronavirus:

1. Chest CT for Typical 2019-nCoV Pneumonia: Relationship to Negative RT-PCR Testing: Radiology. https://doi.org/10.1148/radiol.2020200343. Accessed Feb. 14, 2020

2. Time Course of Lung Changes On Chest CT During Recovery From 2019 Novel Coronavirus (COVID-19) Pneumonia: Radiology. https://doi.org/10.1148/radiol.2020200370. Accessed Feb. 14, 2020

3. U.S. Food and Drug Administration: https://www.fda.gov/news-events/press-announcements/fda-takes-significant-step-coronavirus-response-efforts-issues-emergency-use-authorization-first?utm_campaign=020420_PR_FDA%20Issues%20EUA%20for%20First%202019%20Novel%20Coronavirus%20Diagnostic&utm_medium=email&utm_source=Eloqua. Accessed Feb. 14, 2020.

4. Public Health News Alert: CMS Develops New Code for Coronavirus Lab Test. https://www.cms.gov/. Accessed Feb. 14, 2020.

 

Related Coronavirus Imaging Content:

Radiologists Describe Coronavirus CT Imaging Features

CDC Hopes to Buy Time Before Likely Coronavirus Spread in U.S.

CT Imaging of the 2019 Novel Coronavirus (2019-nCoV) Pneumonia

Infervision in the Frontlines Against the Coronavirus

CT Imaging Features of 2019 Novel Coronavirus (2019-nCoV)

Chest CT Findings of Patients Infected With Novel Coronavirus 2019-nCoV Pneumonia 

Find more related clinical content Coronavirus (COVID-19)

Novel coronavirus (COVID-19)

Related Content

The multi-pronged initiative includes BWHI’s P.O.W.E.R. of Sure campaign, which will examine common barriers to early screening and encourage Black women to schedule and attend their annual mammograms. The campaign features Grammy Award winning, Oscar and Golden Globe nominated artist Mary J. Blige and a multimedia digital hub with resources including common facts and myths about mammography, frequently asked questions regarding breast cancer and screening guidelines, a list of locations offering breast can

The campaign features Grammy Award winning, Oscar and Golden Globe nominated artist Mary J. Blige.

Photographer: Robert Ector

News | Women's Health | October 01, 2020
October 1, 2020 — Hologic, Inc.
These MRI scans show diffuse white matter abnormality (DWMA). The top three panels display raw MRI images from very preterm infants born at 27 weeks (left), 26 weeks (center) and 31 weeks (right) gestation.

These MRI scans show diffuse white matter abnormality (DWMA). The top three panels display raw MRI images from very preterm infants born at 27 weeks (left), 26 weeks (center) and 31 weeks (right) gestation. Higher signal intensity can be seen in the central white matter, particularly for the 31-week gestation infant. The bottom panels display the corresponding slices with objectively segmented DWMA in yellow. The 27-week infant (left) was diagnosed with mild DWMA, the 26-week infant (center) was diagnosed with moderate DWMA, and the 31-week infant had severe DWMA. Image courtesy of Cincinnati Children's and Nature Scientific Reports

News | Magnetic Resonance Imaging (MRI) | October 01, 2020
October 1, 2020 — As many as 70% of very premature infants (born earlier than 32 weeks gestation) show signs of white
Newly released study results present a strong case for lung cancer screening in New Zealand — particularly for Māori whose mortality rates are between three and four times higher than other ethnic groups.

Image courtesy of Siemens Healthineers

News | Lung Imaging | September 30, 2020
September 30, 2020 — Newly released study results present a strong case for...
The artificial intelligence-driven Caption Guidance software guides point of care ultrasound (POCUS) users to get optimal cardiac ultrasound images. The AI software is an example of a FDA-cleared software that is helping improve imaging, even when used by less experienced users.

The artificial intelligence-driven Caption Guidance software guides point of care ultrasound (POCUS) users to get optimal cardiac ultrasound images. The AI software is an example of a FDA-cleared software that is helping improve imaging, even when used by less experienced users.

Feature | Artificial Intelligence | September 29, 2020 | Joe Fornadel, J.D., and Wes Moran, J.D.
The number of Federal Drug Administration (FDA)-approved AI-based algorithms is significant and has grown at a steady
The FDA Center for Devices and Radiological Health's COVID-19 response by the numbers between January 1 and September 18, 2020.

The FDA Center for Devices and Radiological Health's COVID-19 response by the numbers between January 1 and September 18, 2020. Graphic courtesy of FDA

News | Coronavirus (COVID-19) | September 29, 2020
September 29, 2020 — On September 28, FDA Commissioner of Food and Drugs...