Medical Device

Classification
 US Laws and Regulations on
Device Classification

 Federal Food, Drug and Cosmetic Act (FD&C

Act): Section 513, 514(b), 515(b), 520(l)

 Title 21 of the Code of Federal Regulation, Part

860 (21CFR 860)
 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,
502, 510, 516, 518, 519, 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
 Special Controls
 Guidance (e.g., Glove Manual)
 Mandatory performance standard
 Special labeling
 21CFR 882.5970 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
 Confidentiality of Information
Submitted for Classification
 21CFR 860.5 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
(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 20.61
 Safety and effectiveness data affecting other devices of the

same generic type

 Data submitted under FD&C 513,514, 515, 516, 518, 519, 520

that exempted from public disclosure under 21CFR20.61

 Safety and Effectiveness
Determination for Classification
 Factors contributing to safety and effectiveness
determination

 Intended patients
 Conditions of use, including conditions recommended
in labeling and advertisement
 Probable benefit vs risk
 Reliability
 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, its
conditions of use, the existence and adequacy of warnings and
other restrictions, and the extent of experience with its use.
 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, 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, that the probable benefits to

health from use of the device for its intended uses
and conditions of use, when accompanied by
adequate directions and warnings against unsafe use,
outweigh any probable risks.
 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.
 Safety and Effectiveness
Determination for Classification
(Continued 2)
 There is reasonable assurance that a device is
effective
 When it can be determined, based upon valid

scientific evidence, that in a significant portion of the

target population, the use of the device for its
intended uses and conditions of use, when
accompanied by adequate directions for use and
warnings against unsafe use, will provide clinically
significant results.
 The valid scientific evidence used to determine the

effectiveness of a device shall consist principally of

well-controlled investigations
 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

 Classification of Device in
Commerce prior to May 28, 1976
 Definition of Medical Device
An instrument, apparatus, implement, machine, contrivance, implant,
in vitro reagent, or other similar or related article, including any
component, part, or accessory, which is

 recognized in the official National Formulary, or the United States

Pharmacopeia, or any supplement to them,
 intended for the diagnosis of disease or other conditions, or in the
cure, mitigation, treatment, or prevention of disease, in man or other
animals, or
 intended to affect the structure or any function of the body of 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.
 Quiz

Any unclassified devices?