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HHS/FDA | RIN: 0910-AC32 | Publication ID: Fall 2003 |
Title: Medical Devices; Patient Examination and Surgeons' Gloves; Adulteration | |
Abstract: The Food and Drug Administration (FDA) is proposing to amend the sampling plans, test method, and acceptable quality levels in 21 CFR 800.20. As prescribed by this regulation, FDA samples patient examination and surgeons' gloves and examines them for visual defects and water leaks. Glove lots are considered adulterated if they do not meet specified quality levels. This proposal would clarify sampling plans and the scoring of defects, lower acceptance rates for leaking gloves, raise rejection rates for leaking gloves, and add tightened inspection schemes for reexamined glove lots. The rule is intended to facilitate industry compliance and enhance the safety and effectiveness of gloves. | |
Agency: Department of Health and Human Services(HHS) | Priority: Substantive, Nonsignificant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
Major: No | Unfunded Mandates: No |
CFR Citation: 21 CFR 800.20 | |
Legal Authority: 21 USC 321 21 USC 331 21 USC 351 21 USC 352 21 USC 371 21 USC 374 |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: Undetermined |
Federalism: Undetermined | |
Included in the Regulatory Plan: No | |
Agency Contact: Joseph M. Sheehan Chief, Regulations Staff Department of Health and Human Services Food and Drug Administration HFZ-215, Center for Devices and Radiological Health, HFZ-215, 1350 Piccard Drive, Rockville, MD 20850 Phone:301 827-2974 Fax:301 594-4765 Email: joseph.sheehan@fda.hhs.gov |