APPLE ROCK ACHIEVES FDA REGISTRATION AND FEDERAL GRANT FOR PPE TESTING
Greensboro, NC— Apple Rock Advertising & Promotion, Inc. (“Apple Rock” or the “Company”) is pleased to announce confirmation of its U.S. Food and Drug Administration (“FDA”) Facility Registration and Device Listing for our Non-Surgical Isolation Gown and Clear Panel Face Mask (Accessory, Surgical, Apparel). Apple Rock also recently received confirmation of acceptance by North Carolina State University/Industry Expansion Solutions (IES) to receive an NCMEP EAP Grant for further PPE Testing of their products by Nelson Labs.
Eric Burg, CEO of Apple Rock, states that “Confirmation of our FDA Registration for our North Carolina facility is validation of all the hard work we have done this last year to produce quality PPE products for our government, our communities and our customers. The grant allows us to further test and prove the reliability.”
All medical device companies must be registered with the FDA. Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States are required to register annually with the FDA. This process is known as establishment registration. The required annual registration is a review of all the information for a given facility and its associated device listings. Congress has authorized the FDA to collect an annual establishment registration fee for device establishments. Most establishments that are required to register with FDA are also required to list the devices that are made there and the activities that are performed on those devices. Registration and listing provide FDA with the location of medical device establishments and the devices manufactured at those establishments.