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Identification. A chilling unit is a refrigerative device intended for medical purposes to chill and maintain cold packs at a reduced temperature.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9
This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.
This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].
It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.
§ 351 - Adulterated drugs and devices
§ 360 - Registration of producers of drugs or devices
§ 360c - Classification of devices intended for human use
§ 360e - Premarket approval
§ 360j - General provisions respecting control of devices intended for human use
§ 371 - Regulations and hearings
Title 21 published on 2015-04-01
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 890 after this date.
The Food and Drug Administration (FDA or the Agency) is publishing an order granting a petition requesting exemption from premarket notification requirements for electric positioning chair devices. An electric positioning chair is a device with a motorized positioning control that is intended for medical purposes and that can be adjusted to various positions. These devices are used to provide stability for patients with athetosis (involuntary spasms) and to alter postural positions. This order exempts electric positioning chairs, class II devices, from premarket notification, subject to certain conditions for exemption. This exemption from premarket notification, subject to these conditions (and the limitations in the physical medicine devices limitations of exemptions from premarket notification section of the device regulations), is immediately in effect for electric positioning chairs. FDA is publishing this order in accordance with the exemption from class II premarket notification section of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
The Food and Drug Administration (FDA) is issuing a final order to reclassify shortwave diathermy (SWD) for all other uses, a preamendments class III device, into class II (special controls), and to rename the device “nonthermal shortwave therapy” (SWT). FDA is also making a technical correction in the regulation for the carrier frequency for SWD and SWT devices.
The Food and Drug Administration (FDA or the Agency) is republishing in its entirety a final order entitled “Medical Devices; Physical Medicine Devices; Classification of the Powered Lower Extremity Exoskeleton” that published in the Federal Register on February 24, 2015. FDA is republishing to correct an inadvertent omission of information. FDA is classifying the powered lower extremity exoskeleton into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the powered lower extremity exoskeleton's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.