The federal government relies on vendors to provide products which meet federal contract guidelines. In the midst of a global pandemic where traditional supply lines are constrained and fake products are entering the market it is important to have federal partners that make it their duty to provide the federal government with high quality products that fit government requirements.
Focus on a few products
We focus on a small set of products where we have direct factory or authorized dealer relationships. Purchasing products through unknown middle men increases the risk of fraud. We have direct factory relationships that provide the following essential products.
|N95 Masks||Surgical Masks|
|3 Ply Masks||Medical Gowns|
|Nitrile Gloves||Cleaning supplies|
Help suppliers verify their claims
We increase quality by helping our suppliers verify the claims they make about their products. They might have a product that is CE approved, which only requires manufacturer reported data. However they may have never tested the product. We ask suppliers to provide test results that back up their claims. Your literature claims that the product is a level 1 gown, or a level 3 gown. Are there test results to confirm this? Has the level 3 gown been 510(k) cleared as required by the FDA? If the product has not been tested we help them locate testing resources through reputable labs to get the products tested so that they can advertise and label with confidence. We don’t want to get a factory product into a high volume federal contract only to have it retested and rejected by the federal government.
In order to increase availability of medical devices in a pandemic the FDA has allowed products to be imported under Emergency Use Authorization and Selective Enforcement rules. Emergency Use Authorization allows products to apply for authorization on a case by case basis using certifications of approval from other regions. They require registration and listing but bypass the 510(k) clearance process.
Selective Enforcement rules go even further, allowing specific categories of devices to be imported without even Registration and Listing. It only requires the product to be properly labeled for the intended use. This leaves the burden on the customer to identify fraudulent products. That only leads to headlines like the following:
Fake N95 masks sold in 5 states in massive scam, federal investigators say
FDA Consulting Services
One purpose of our FDA Consulting Services is to help build a list of suppliers with vetted products that meet FDA requirements. We can then connect those suppliers with our customers so that they can purchase their critical medical devices with confidence.