On December 13, 2012, the FDA issued two draft guidance documents related to product safety and risk minimization. The first guidance, Design Considerations for Devices Intended for Home Use, is intended to assist to assist manufacturers in designing and developing home use medical devices that comply with applicable standards of safety and effectiveness and other regulatory requirements. The guidance identifies several factors that manufacturers should consider, especially during device design and development, and provides recommendations for reducing or minimizing these unique risks. Factors to consider in designing and developing medical devices for home use include the physical environment, the user, the device or system, the labeling, and the utilization of human factors. The guidance applies to both prescription and over-the-counter medical devices that are intended for home use. The second guidance, Safety Considerations for Product Design to Minimize Medication Errors, provides sponsors of IND applications, new drug applications, biologics licensing applications, abbreviated new drug applications, and nonprescription drugs marketed without an approved application with a set of principles for developing drug products using a systems approach to minimize medication errors relating to product design. The recommendations in the guidance are intended to improve the drug product and container closure design at the earliest stages of product development for all prescription and nonprescription drug products. This draft guidance is the first in a series of three planned guidance documents to minimize risks contributing to medication errors. Comments on both guidance documents should be submitted to www.regulations.gov by March 13, 2013.