General hospital and personal use devices; classification of the Apgar timer, lice removal kit, and infusion stand--FDA. Proposed rule

Publication Type:Journal Article
Year of Publication:1998
Journal:Federal Register
Pagination:11632 - 11633
Date Published:1998
ISBN Number:0097-6326
Keywords:animals, Apgar Score, humans, Infant, Insect Control, Lice, U.S.A.

The Food and Drug Administration (FDA) is proposing to classify the Apgar timer, lice removal kit, and infusion stand into class I. FDA is also publishing the recommendations of the General Hospital and Personal Use Devices Panel (the panel) regarding the classification of the devices. After considering public comments on the proposed classification, FDA will publish a final regulation classifying the devices. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA).

Scratchpads developed and conceived by (alphabetical): Ed Baker, Katherine Bouton Alice Heaton Dimitris Koureas, Laurence Livermore, Dave Roberts, Simon Rycroft, Ben Scott, Vince Smith