Source: https://www.law.cornell.edu/cfr/text/21/part-878/subpart-A
Timestamp: 2017-02-26 06:18:19
Document Index: 291900868

Matched Legal Cases: ['art 878', 'art 878', 'art 878', '§ 878', '§ 878', '§ 878', 'art 878', 'art 878', 'art 878', 'art 878', 'art 878', 'art 878', 'art 878']

21 CFR Part 878, Subpart A - General Provisions | US Law | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter H › Part 878 › Subpart A 21 CFR Part 878, Subpart A - General Provisions
§ 878.1 Scope.
§ 878.3 Effective dates of requirement for premarket approval.
§ 878.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
Title 21 published on 2015-12-03The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 878 after this date.2016-12-19; vol. 81 # 243 - Monday, December 19, 201681 FR 91722 - Banned Devices; Powdered Surgeon&apos;s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon&apos;s Glove
2016-09-21; vol. 81 # 183 - Wednesday, September 21, 201681 FR 64761 - Medical Devices; General and Plastic Surgery Devices; Classification of the Magnetic Surgical Instrument System
typeregulations.gov FR Doc.2016-22709 RIN Docket No.FDA-2016-N-2562 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective September 21, 2016. The classification was applicable on June 13, 2016. 21 CFR Part 878 SummaryThe Food and Drug Administration (FDA) is classifying the Magnetic Surgical Instrument System 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 magnetic surgical instrument system&apos;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.
2016-06-29; vol. 81 # 125 - Wednesday, June 29, 201681 FR 42243 - Medical Devices; General and Plastic Surgery Devices; Classification of the Electrosurgical Device for Over-the-Counter Aesthetic Use
typeregulations.gov FR Doc.2016-15381 RIN Docket No.FDA-2016-N-1618 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective June 29, 2016. The classification was applicable on December 18, 2015. 21 CFR Part 878 SummaryThe Food and Drug Administration (FDA) is classifying the electrosurgical device for over-the-counter aesthetic use 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 electrosurgical device for over-the-counter aesthetic use&apos;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.
2016-03-03; vol. 81 # 42 - Thursday, March 3, 201681 FR 11140 - General and Plastic Surgery Devices; Reclassification of Blood Lancets
typeregulations.gov FR Doc.2016-04578 RIN Docket No.FDA-2016-N-0400 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed order. Submit either electronic or written comments on the proposed order by June 1, 2016. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (PRA) by April 4, 2016, (see the “Paperwork Reduction Act of 1995” section of this document). See section X of the SUPPLEMENTARY INFORMATION section of this document for the proposed effective date of any final order that may publish based on this proposal. 21 CFR Part 878 SummaryThe Food and Drug Administration (FDA or the Agency) is proposing to reclassify the following three types of blood lancets used to puncture skin to obtain a drop of blood for diagnostic purposes from class I (general controls) exempt from premarket notification into class II (special controls) and subject to premarket review: Single use only blood lancets with an integral sharps injury prevention feature, single use only blood lancets without an integral sharps injury prevention feature, and multiple use blood lancets for single patient use only. FDA is identifying proposed special controls for these types of blood lancets that we believe are necessary to provide a reasonable assurance of safety and effectiveness. FDA is also proposing to reclassify multiple use blood lancets for multiple patient use from class I (general controls) exempt from premarket notification into class III (premarket approval). FDA is proposing the reclassification of these four types of blood lancets on its own initiative based on new information.
81 FR 11151 - Effective Date of Requirement for Premarket Approval for Blood Lancets
typeregulations.gov FR Doc.2016-04579 RIN Docket No.FDA-2016-M-0035 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed order. Submit either electronic or written comments on this proposed order by June 1, 2016. See section X of the SUPPLEMENTARY INFORMATION section of this document for the proposed effective date of any final order that may publish based on this proposal. 21 CFR Part 878 SummaryThe Food and Drug Administration (FDA) is issuing a proposed administrative order to require the filing of a premarket approval application (PMA) following the reclassification of multiple use blood lancets for multiple patient use from class I to class III. FDA is summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring this device to meet the PMA requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and the benefits to the public from the use of the device.
2016-02-12; vol. 81 # 29 - Friday, February 12, 201681 FR 7452 - Medical Devices; General and Plastic Surgery Devices; Classification of the Scalp Cooling System To Reduce the Likelihood of Chemotherapy-Induced Alopecia
typeregulations.gov FR Doc.2016-02878 RIN Docket No.FDA-2016-N-0237 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective February 12, 2016. The classification was applicable on December 8, 2015. 21 CFR Part 878 SummaryThe Food and Drug Administration (FDA) is classifying the scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia 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 scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia&apos;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.
2015-12-22; vol. 80 # 245 - Tuesday, December 22, 201580 FR 79493 - General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products
typeregulations.gov FR Doc.2015-32024 RIN0910-AH14 Docket No.FDA-2015-N-1765 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule. Submit either electronic or written comments on the proposed rule by March 21, 2016. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by February 22, 2016. See Section VIII for the proposed effective date of a final rule based on this proposed rule. 21 CFR Part 878 SummaryThe Food and Drug Administration (FDA or the Agency) is proposing to establish device restrictions for sunlamp products, which would restrict their use to individuals age 18 and older, require prospective users to sign a risk acknowledgement certification before use, and require the provision of user manuals.