• by Signup Training

The FDA had recently released a publication in regard to the steps they’re taking to ensure quality of foreign products during these uncertain times of COVID-19. They’re taking a multi-pronged approach to ensure safety of the public by focusing on steps that facilitate efforts to diagnose, treat and prevent the disease.

Let’s look at some of the efforts they’re making to further curtail the spread of this deadly virus:

1. Surveilling medical products supply chain

The FDA is monitoring medical products and food safety of all items coming in from China. They are also monitoring the global drug supply chain by prioritizing through risk-based inspections in other parts of the world. Some of the additional tools being used to monitor products coming from outside include import screening, examinations, sampling, and import alerts. They’re also relying on a firm’s previous compliance history, and information from foreign governments as part of mutual recognition agreements.

2. Reviewing records before on-site inspection

According to The Federal Food, Drug, and Cosmetic Act, as amended by the FDA Safety and Innovation Act (FDASIA) of 2012, the FDA has the authority to request records in advance of an on-site drug inspection. This will allow the FDA to review records ahead of time and take a more risk-based approach to conducting both domestic and foreign inspections.

3. Working with the U.S. Customs and Border Protection

The FDA is continuously working with the US Customs and Border Protection Units to inspect products that are being imported to the US. These inspections are being conducted to identify products that violate FDA regulations. With the FDA risk-based import screening tool they hope to focus on examinations based on heightened concerns of specific products being entered into U.S. commerce.

4. Monitoring market for fraudulent COVID-19 prevention claims

The FDA is continuously monitoring the market to identify products that are falsely claiming cures against the COVID-19 infection. The FDA has put out a clear warning that they can and will use all the power in their authority to protect consumers from those who’re trying to monetize this situation.

All medical device manufacturers will soon be visited by the FDA for an inspection. To know how to best be prepared for this visit attend our Seminar on Regulatory Inspections – How to Prepare for a Visit from an FDA Auditor.