United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2001_register executive 2010-09-24 article Rules and Regulations D09002ee1c81e102d D09002ee1c81e10a2 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is classifying the B- type natriuretic peptide (BNP) test system into class II (special controls). The special control that will apply to this device is a guidance document entitled "Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers." The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997. The agency is classifying these devices into class II (special controls) in order to provide a reasonable assurance of the safety and effectiveness of the device. 66 FR 12733 https://www.govinfo.gov/app/details/FR-2001-02-28/01-4847 01-4847 fr28fe01-6 4160-01-F Docket No. 00P-1675 https://www.govinfo.gov/app/details/FR-2001-02-28/01-4847 https://www.govinfo.gov/content/pkg/FR-2001-02-28/html/01-4847.htm https://www.govinfo.gov/content/pkg/FR-2001-02-28/pdf/01-4847.pdf Medical Devices 2 p. 12733 12734 66 FR 12733 Title 21 Part 862 21 CFR Part 862 Clinical Chemistry and Clinical Toxicology Devices; Classification of B-Type Natriuretic Peptide Test System; Federal Register Vol. 66, Issue RULE 01-4847 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2001-02-28 Docket No. 00P-1675 4160-01-F 01-4847 Final rule.

The Food and Drug Administration (FDA) is classifying the B- type natriuretic peptide (BNP) test system into class II (special controls). The special control that will apply to this device is a guidance document entitled "Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers." The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997. The agency is classifying these devices into class II (special controls) in order to provide a reasonable assurance of the safety and effectiveness of the device.

This rule is effective February 28, 2001. Jean M. Cooper, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 301-594-1293. Medical Devices Medical devices: Clinical chemistry and clinical toxicology devices B-type natriuretic peptide test system; classification, http://www.fda.gov/cdrh http://www.fda.gov/cdrh/ode/guidance/1072.pdf Vol. 66, no. 40 Office of the Federal Register, National Archives and Records Administration 2001-02-28 continuing daily deposited born digital 130 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2001-02-28 P0b002ee180a1af68 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr28fe01 https://www.govinfo.gov/app/details/FR-2001-02-28 https://www.govinfo.gov/content/pkg/FR-2001-02-28/pdf/FR-2001-02-28.pdf https://www.govinfo.gov/content/pkg/FR-2001-02-28/xml/FR-2001-02-28.xml fdlp 12723 12841 DGPO 2010-09-24 2024-06-08 FR-2001-02-28 machine generated eng FR FR-2001-02-28 66 40