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Medical Device Classification

Medical Device Classification

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Published by: usluipek on Dec 11, 2010
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05/15/2013

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Medical Device Classification

Drug and Cosmetic Act (FD&C Act): Section 513. 520(l) Title 21 of the Code of Federal Regulation. 515(b).US Laws and Regulations on Device Classification Federal Food. Part 860 (21CFR 860) . 514(b).

and 520 Prohibition of adulteration and misbranding Premarket notification (510k) Registration and listing Quality Systems Device Labeling Regulation Prohibition of banned device Reporting of adverse events Reporting of correction and removal .General Controls Defined in FD&C Act Section 513(h) and 513(a)(1)(A) Refer to the controls authorized by FD&C Sections 501. 516. 502. 519. 510. 518.

Special Controls Guidance (e.. Glove Manual) Mandatory performance standard Special labeling 21CFR 882.g.5970 Cranial Orthosis 21CFR 884.5300 condom Postmarket surveillance Recommendations or other actions .

Device Classification Panel Devices intended for human use are organized according to various fields of clinical medicine and fundamental sciences .

Device Classification Panel (Continued) 21CFR 862 Clinical Chemistry&Toxicology 21CFR 864 Hematology and Pathology 21CFR 866 Immunology and Microbiology 21CFR 868 Anesthesiology 21CFR 870 Cardiovascular 21CFR 872 Dental 21CFR 874 Ear. Nose and Throat 21CFR 876 Gastroenterology-Urology .

Device Classification Panel (Continued) 21 CFR 878 General and Plastic Surgery 21 CFR 880 General Hospital and Personal Use 21 CFR 882 Neurological 21 CFR 884 Obstetrical and Gynecological 21 CFR 886 Ophthalmic 21 CFR 888 Orthopedic 21 CFR 890 Physical Medicine 21 CFR 892 Radiology .

5 and 21CFR 20 Specifies what and when information is made public Public: Data and information submitted to classification panels under 21CFR 860.84 .Confidentiality of Information Submitted for Classification 21CFR 860.

61 .514.61 Safety and effectiveness data affecting other devices of the same generic type Data submitted under FD&C 513. 518. 520 that exempted from public disclosure under 21CFR20. 515. 516.Confidentiality of Information Submitted for Classification (Continued) Confidential: Information exempt from public disclosure in accordance with 21CFR 20 Previouly undisclosed safety and effectiveness information for Class III Trade secrets and confidential commercial information described in 21CFR 20. 519.

including conditions recommended in labeling and advertisement Probable benefit vs risk Reliability .Safety and Effectiveness Determination for Classification Factors contributing to safety and effectiveness determination Intended patients Conditions of use.

Safety and Effectiveness Determination for Classification (Continued 1) FDA relies upon valid scientific evidence for determining safety and effectiveness The commissioner determines whether information submitted is valid scientific evidence Evidence required varies with characteristics of the device. Valid scientific evidence is evidence from controlled and not controlled investigations and studies conducted by qualified experts. well-documented case histories. . and reports of significant human experience with a marketed device. and the extent of experience with its use. the existence and adequacy of warnings and other restrictions. its conditions of use. from which it can fairly and responsibly be concluded by qualified experts that there is reasonable assurance of the safety and effectiveness of a device under its conditions of use.

Safety and Effectiveness Determination for Classification (Continued 2) There is reasonable assurance that a device is safe When it can be determined. based upon valid scientific evidence. . when accompanied by adequate directions and warnings against unsafe use. that the probable benefits to health from use of the device for its intended uses and conditions of use. The valid scientific evidence used to determine the safety of a device shall adequately demonstrate the absence of unreasonable risk of illness or injury associated with the use of the device for its intended uses and conditions of use. outweigh any probable risks.

the use of the device for its intended uses and conditions of use.Safety and Effectiveness Determination for Classification (Continued 2) There is reasonable assurance that a device is effective When it can be determined. will provide clinically significant results. The valid scientific evidence used to determine the effectiveness of a device shall consist principally of well-controlled investigations . based upon valid scientific evidence. when accompanied by adequate directions for use and warnings against unsafe use. that in a significant portion of the target population.

Safety and Effectiveness Determination for Classification (Continued 2) Well controlled study protocol used to establish effectivenss should include: Statement of objectives Method of subjects selection Methods of observation and rerording Comparison results with control Methods of analysis and evaluation of test data Test device that is standardized in composition. design and performance .

1976 .Classification of Device in Commerce prior to May 28.

in man or other animals. and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. . or other similar or related article. part. or any supplement to them. mitigation. or accessory. which is recognized in the official National Formulary. implement. implant. or the United States Pharmacopeia. or intended to affect the structure or any function of the body of man or other animals. or in the cure.Definition of Medical Device An instrument. apparatus. in vitro reagent. machine. treatment. intended for the diagnosis of disease or other conditions. contrivance. or prevention of disease. including any component.

Quiz Any unclassified devices? .

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