federal_register: 2012-30033

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2012-30033 Draft Guidance for Industry and Food and Drug Administration Staff; Design Considerations for Devices Intended for Home Use; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Design Considerations for Devices Intended for Home Use." This document is intended to assist manufacturers in designing and developing home use medical devices that comply with applicable standards of safety and effectiveness and other regulatory requirements. Home use devices are associated with unique risks created by the interactions among the user (often a layperson), the use environment, and the device. This document identifies several factors that manufacturers should consider, especially during device design and development, and provides recommendations for reducing or minimizing these unique risks. This draft guidance is not final nor is it in effect at this time. 2012-12-13 2012 12 https://www.federalregister.gov/documents/2012/12/13/2012-30033/draft-guidance-for-industry-and-food-and-drug-administration-staff-design-considerations-for-devices https://www.govinfo.gov/content/pkg/FR-2012-12-13/pdf/2012-30033.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Design Considerations for Devices Intended for Home Use." This document is intended to assist manufacturers in designing and developing home use...

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