Medical Device News Magazine

COVID-19 FDA Update: Foreign Inspections

About Medical Device News Magazine

About Medical Device News Magazine. We are a digital publication founded in 2008 located in the United States.

Advertise with Medical Device News Magazine! Join Our #1 Family of Advertisers!

We pride ourselves on being the best-kept secret when it comes to distributing your news! Our unique digital approach enables us to circulate your...

The FDA based this decision on a number of factors, including State Department Level 4 travel advisories in which travel is prohibited for U.S. government employees, Centers for Disease Control and Prevention travel recommendations, access restrictions being imposed on foreign visitors by certain countries, guidance from the Office of Personnel Management and the importance of the health and safety of our employees.

Another critical factor in taking this action is the confidence we have in our ability to maintain oversight over international manufacturers and imported products using alternative tools and methods.

We are aware of how this action may impact other FDA responsibilities, including product application reviews.  We will be vigilant and monitor the situation very closely and will try to mitigate potential impacts from this outbreak in lockstep with the whole of the federal government. We stand ready to resume foreign inspections as soon as feasible.

When we are temporarily not able to physically inspect foreign produced FDA-regulated products or manufacturers, as an interim measure we employ additional tools to ensure the safety of products imported to the U.S., which have proved effective in the past. These include denying entry of unsafe products into the U.S., physical examinations and/or product sampling at our borders, reviewing a firm’s previous compliance history, using information sharing from foreign governments as part of mutual recognition and confidentiality agreements and requesting records “in advance of or in lieu of” on-site drug inspections. For example, we began exercising this authority when we postponed on-the-ground inspections of manufacturers of FDA-regulated products in China earlier in the outbreak. This is all part of the FDA’s multi-pronged and risk-based approach to ensuring quality, as well as compliance, with applicable federal laws and regulations.

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.

The FDA has the ability through our risk-based import screening tool (PREDICT) to focus our 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.

Americans can rest assured the FDA is diligently monitoring this outbreak and the impact to our operations. Our leadership team meets daily to talk about the myriad of urgent issues facing us as we actively facilitate efforts to diagnose, treat and prevent the disease; survey the medical product supply chain for potential shortages or disruptions and help to mitigate such impacts, as necessary; and leverage the full breadth of our public health tools, including enforcement tools to stop fraudulent COVID-19 activity.

As this remains a dynamic situation, we will continue to assess and calibrate our approach as needed to help advance federal response efforts in the fight against this outbreak.


Other FDA news items can be found here.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Other News

HeartFlow Introduces Next Generation Interactive Plaque Analysis Platform to Assess Patient Risk in Suspected Coronary Artery Disease

The HeartFlow Plaque Analysis uses proprietary algorithms to analyze coronary CT angiogram (CCTA) scans, creating a personalized 3D model that quantifies and characterizes plaque volume in the coronary arteries, aiding risk assessment of coronary artery disease. The technology was introduced at the Society of Cardiovascular Computed Tomography (SCCT) Annual Scientific Meeting in Washington, D.C.

Ultrahuman Announces its App Store ‘PowerPlugs’ with the World’s First AFib Detection Technology on a Smart Ring

Recognizing each individual’s health journey is unique, PowerPlugs enable people to choose and focus on the aspects of their health that matter most. It’s designed for highly personalized health insights, ensuring that every individual can personalize their health tracking to their unique needs and goals.

VisionAir Solutions Celebrates Milestone and New Collaboration

This achievement marks VisionAir Solutions commitment to bringing technological innovation to pulmonary medicine. Since its acquisition by Theken Companies last year, VAS has over doubled its growth and continues to demonstrate industry adoption and the advantages of personalized healthcare.