21 CFR Part 878 Subpart B
21 CFR Part 878 -- General and Plastic Surgery Devices - eCFR
Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). Subpart B · Diagnostic Devices · 878.1800. § 878.1800 ...
21 CFR Part 878 Subpart B -- Diagnostic Devices - eCFR
Displaying title 21, up to date as of 9/04/2024. Title 21 was last amended 9/03/2024. view historical versions.
CFR - Code of Federal Regulations Title 21 - FDA
§ 878.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). Subpart B - Diagnostic Devices · § 878.1800 - ...
21 CFR Subpart B - Subpart B—Diagnostic Devices | US Law
PART 878—GENERAL AND PLASTIC SURGERY DEVICES; Subpart B—Diagnostic Devices. 21 CFR Subpart B - Subpart B—Diagnostic Devices. CFR. prev | next. § 878.1800 ...
21 CFR Part 878 | US Law | LII / Legal Information Institute
21 CFR Part 878 - PART 878—GENERAL AND PLASTIC SURGERY DEVICES. CFR; State ... Subpart B—Diagnostic Devices (§ 878.1800); Subpart C [Reserved]; Subpart D ...
CFR - Code of Federal Regulations Title 21 - FDA
If FDA promulgates a regulation under section 515(b) ... The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter ...
581 PART 878—GENERAL AND PLASTIC SURGERY DEVICES
(b) Classification. Class II (special controls) (FDA guidance document: ''Guidance for the Content of Pre- market Notifications (510 ...
21 CFR §878 General And Plastic Surgery Devices
PART 878 - GENERAL AND PLASTIC SURGERY DEVICES Authority: 21 U.S.C. 351, 360 ... SUBPART B, Subpart B - Diagnostic Devices. 21:8.0.1.1.26.2.1.1, SECTION ...
PART 878—GENERAL AND PLASTIC SURGERY DEVICES - GovInfo
If FDA promul- gates a regulation under section 515(b) of the act requiring premarket ap- proval for a device, section 501(f)(1)(A) of the act applies to the ...
21 CFR Subpart B Diagnostic Devices | Code of Federal ... - LawStack
Part 878 - GENERAL AND PLASTIC SURGERY DEVICES; 21 CFR Subpart B. 21 CFR Subpart B. Diagnostic Devices. June 25, 2020. §. 878.1800. Speculum and accessories.
21 C.F.R. PART 878—GENERAL AND PLASTIC SURGERY DEVICES
§ 878.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). Subpart B—Diagnostic Devices. § 878.1800 Speculum ...
Reclassification of Blood Lancets - Federal Register
... (b) Proposed Order) (81 FR 11151). The proposed orders also stated that FDA proposed to amend 21 CFR part 878 to create a separate regulation ...
FDA Regulation of Medical Devices - CRS Reports
(21 C.F.R. Part 878). Source: Created by CRS. Notes: C.F.R. = Code ... (b)(2); 21 C.F.R. Part 807 Subpart B. 35 FFDCA §510(i); 21 U.S.C. ...
Medical Devices; Classification of Accessories Distinct From Other ...
Food and Drug Administration. 21 CFR Parts 876, 878, and 886; [Docket No. FDA-2018-N-3066] ...
part 878--general and plastic surgery devices
The authority citation for 21 CFR part 878 continues to read as follows: ... (b) Classification. Class II (special controls). The special controls for this ...
21 CFR 26.49 - Regulatory cooperation. - CustomsMobile
Appendix Appendix A - Appendix A to Subpart B of Part 26—Relevant Legislation, Regulations, and Procedures. Appendix Appendix B - Appendix B to Subpart B of ...
21 CFR Part 820: Ultimate Guide to FDA's QSR - Greenlight Guru
What are the FDA Requirements of 21 CFR Part 820—Quality System Regulation? Subpart B—Quality System Requirements Subpart C—Design Controls.
Document (FDA-2023-N-3392-0001) - Regulations.gov
CFR. 21 CFR Part 878. Topic(s). Medical Devices. Document Subtype. Notice of Proposed Rulemaking (NPRM). Received Date. Nov 30, 2023. FR ...
Title 21 Part 26 Appendix B Code of Federal Regulations
Appendix B to Subpart B of Part 26 - Scope of Product Coverage. 21:1.0.1.1 ... General and Plastic Surgery Panel (21 CFR Part 878). 878.4200, Introduction ...
LEGISLATIVE RESEARCH SERVICES - Alaska State Legislature
... Subpart E, or Subpart G of 21 CFR part 884 (Obstetrical and. Gynecological Devices); or. (4) Subpart B of 21 CFR part 890 (Physical Medicine Devices); and ...