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This page lists Medical Device Guidance documents.

As defined by FDA, real-world data (RWD) are the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources and real-world evidence (RWE) is…

Real-world data (RWD) and real-world evidence (RWE) played an increasing role in health care decisions. The 21st Century Cures Act, passed in 2016, placed additional focus on the use of these types of data…

As part of the reauthorization of the Prescription Drug User Fee Act (PDUFA VII), FDA committed to reporting aggregate and anonymized information on submissions to the Center for Biologics Evaluation and…

August Egg Company of Hilmar, CA is recalling 1,700,000 dozen brown cage free and brown certified organic eggs, because they have the potential to be contaminated with Salmonella, an organism which can…

Firehook of Virginia is recalling one lot of Firehook brand Classic Sea Salt Organic Crackers because they may contain undeclared sesame.

TGD Cuts, LLC of Jessup, MD has initiated a voluntary recall of the specific tub and tray items listed below because they contained cucumber from Bedner Growers Inc., which had the potential to be…

Camerican International of Paramus, NJ is recalling 7.05 oz boxes of Aldi Brand Casa Mamita Churro Bites Filled with Chocolate Hazelnut Cream because they may contain undeclared milk. People who have an allergy…

Homegrown Family Foods is recalling its Shore Lunch Oven Style Breader & Batter Mix 6oz Box due to the presence of undeclared milk. Individuals with an allergy or severe sensitivity to milk risk serious…