Devices Guidances
This page lists Medical Device Guidance documents.
Author: fda-agency-news
Center for Biologics Evaluation and Research & Center for Drug Evaluation and Research Real-World Evidence
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 …
Real-World Evidence
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, pl…
Real-World Evidence Submissions to the Center for Biologics Evaluation and Research & the Center for Drug Evaluation and Research
As part of the reauthorization of the Prescription Drug User Fee Act (PDUFA VII), FDA committed to reporting aggregate and anonymized information on s…
August Egg Company Recalls Shell Eggs Because of Possible Health Risk
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 …
Firehook of Virginia Issues Allergy Alert on Undeclared Sesame in Classic Sea Salt Crackers
Firehook of Virginia is recalling one lot of Firehook brand Classic Sea Salt Organic Crackers because they may contain undeclared sesame.
Tgd Cuts, LLC Initiated Voluntary Recall of Cucumber from Bedner Growers Inc., Which Had the Potential to Be Contaminated with Salmonella
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 Bedn…
Camerican International, Inc. Issues Allergy Alert on Undeclared Milk in Aldi Brand Casa Mamita Churro Bites Filled with Chocolate Hazelnut Cream
Camerican International of Paramus, NJ is recalling 7.05 oz boxes of Aldi Brand Casa Mamita Churro Bites Filled with Chocolate Hazelnut Cream because …
Homegrown Family Foods Issues Allergy Alert on Undeclared Milk in Shore Lunch Oven Style Breader & Batter Mix
Homegrown Family Foods is recalling its Shore Lunch Oven Style Breader & Batter Mix 6oz Box due to the presence of undeclared milk. Individuals with a…
Isabelle’s Kitchen Inc. Recalls Refrigerated Deli Salads Containing Fresh Cucumbers Because of Possible Health Risk
Isabelle's Kitchen, Inc., Harleysville, PA, is recalling 946 cases of refrigerated deli salads containing fresh cucumbers recalled by Bedner Grower’…