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device, the classification panels and deficiencies in the same manner as the the Commissioner may consider safety original petition, and the same proceand effectiveness data developed for dures for notification and correction of another device in the same generic deficiencies are followed. Once the petype, regardless of whether such data titioner has corrected the deficiencies, are regarded currently as confidential the entire contents of the petition will under paragraph (c)(1) of this section. be available for public disclosure and

(d)(1) The fact of its existence and subject to consideration by classificathe contents of a petition for reclassi- tion panels and by the Commissioner in fication filed accordance with making a decision on the petition. De$860.130 or $860.132 are available for ficient petitions which have not been public disclosure at the time the peti- corrected within 180 days after notifition is received by the Food and Drug cation of deficiency will be returned to Administration.

the petitioner and will not be consid(2) The fact of the existence of a peti- ered further unless resubmitted. tion for reclassification filed in accord- (e) The Commissioner may not disance with 8860.134 or $ 860.136 is avail

close, or use as the basis for reclassiable for public disclosure at the time fication of a device from class III to the petition is received by the Food

class II, any information reported to or and Drug Administration. The contents

otherwise obtained by the Commisof such a petition are not available for sioner under section 513, 514, 515, 516, public disclosure for the period of time

518, 519, 520(f), 520(g), or 704 of the act following its receipt (not longer than 30 that falls within the exemption dedays) during which the petition is re- scribed in $20.61 of this chapter for viewed for any deficiencies preventing trade secrets and confidential commerthe Commissioner from making a deci

cial information. The exemption desion on it. Once it is determined that

scribed in $20.61 does not apply to data the petition contains no deficiencies

or information contained in a petition preventing the Commissioner from

for reclassification submitted in acmaking a decision on it, the petition cordance with $ 860.130 or $860.132, or in will be filed with the Dockets Manage- a petition submitted in accordance ment Branch and its entire contents

with $860.134 or $ 860.136 that has been will be available for public disclosure determined to contain no deficiencies and subject to consideration by classi

that prevent the Commissioner from fication panels and by the Commis

making a decision on it. Accordingly, sioner in making a decision on the pe- all data and information contained in tition. If, during this 30-day period of such petitions may be disclosed by the time, the petition is found to contain

Commissioner and used as the basis for deficiencies that prevent the Commis- reclassification of a device from class sioner from making a decision on it, III to class II. the petitioner will be so notified and

(f) For purposes of this section, safeafforded an opportunity to correct the

ty and effectiveness data include data deficiencies.

and results derived from all studies and Thirty days after notice to the peti- tests of a device on animals and hutioner of deficiencies in the petition, mans and from all studies and tests of the contents of the petition will be the device itself intended to establish available for public disclosure unless, or determine its safety and effectivewithin that 30 days, the petitioner sub- ness. mits supplemental material intended to correct the deficiencies in the peti- 8860.7 Determination of safety and eftion. The Commissioner, in the Com

fectiveness. missioner's discretion, may allow with- (a) The classification panels, in redrawal of a deficient petition during viewing evidence concerning the safety the 30-day period provided for cor- and effectiveness of a device and in prerecting deficiencies. Any supplemental paring advice to the Commissioner, and material submitted by the petitioner, the Commissioner, in making detertogether with the material in the origi- minations concerning the safety and nal petition, is considered as a new pe- effectiveness of a device, will apply the tition. The new petition is reviewed for rules in this section.

(b) In determining the safety and ef- ence and adequacy of warnings and fectiveness of a device for purposes of other restrictions, and the extent of exclassification, establishment of per- perience with its use. Isolated case reformance standards for class II devices, ports, random experience, reports lackand premarket approval of class III de- ing sufficient details to permit scivices, the Commissioner and the classi- entific evaluation, and unsubstantiated fication panels will consider the fol- opinions are not regarded as valid scilowing, among other relevant factors:

entific evidence to show safety or effec(1) The persons for whose use the de- tiveness. Such information may be convice is represented or intended;

sidered, however, in identifying a de(2) The conditions of use for the de- vice the safety and effectiveness of vice, including conditions of use pre- which is questionable. scribed, recommended, or suggested in (d)(1) There is reasonable assurance the labeling or advertising of the de

that a device is safe when it can be device, and other intended conditions of

termined, based upon valid scientific use;

evidence, that the probable benefits to (3) The probable benefit to health

health from use of the device for its infrom the use of the device weighed

tended uses and conditions of use, when against any probable injury or illness

accompanied by adequate directions from such use; and

and warnings against unsafe use, out(4) The reliability of the device.

weigh any probable risks. The valid sci(c)(1) Although the manufacturer

entific evidence used to determine the may submit any form of evidence to

safety of a device shall adequately the Food and Drug Administration in

demonstrate the absence of unreasonan attempt to substantiate the safety and effectiveness of a device, the agen

able risk of illness or injury associated

with the use of the device for its incy relies upon only valid scientific evi

tended uses and conditions of use. dence to determine whether there is reasonable assurance that the device is

(2) Among the types of evidence that safe and effective. After considering

may be required, when appropriate, to the nature of the device and the rules

determine that there is reasonable as

surance that a device is safe are invesin this section, the Commissioner will determine whether the evidence sub

tigations using laboratory animals, inmitted or otherwise available to the

vestigations involving human subjects, Commissioner is valid scientific evi

and nonclinical investigations includdence for the purpose of determining

ing in vitro studies. the safety or effectiveness of a par

(e)(1) There is reasonable assurance ticular device and whether the avail

that a device is effective when it can be able evidence, when taken as a whole,

determined, based upon valid scientific is adequate to support a determination

evidence, that in a significant portion that there is reasonable assurance that

of the target population, the use of the the device is safe and effective for its device for its intended uses and condiconditions of use.

tions of use, when accompanied by ade(2) Valid scientific evidence is evi- quate directions for use and warnings dence from well-controlled investiga- against unsafe use, will provide clinitions, partially controlled studies, cally significant results. studies and objective trials without (2) The valid scientific evidence used matched controls, well-documented to determine the effectiveness of a decase histories conducted by qualified vice shall consist principally of wellexperts, and reports of significant controlled investigations, as defined in human experience with a marketed de- paragraph (f) of this section, unless the vice, from which it can fairly and re- Commissioner authorizes reliance upon sponsibly be concluded by qualified ex- other valid scientific evidence which perts that there is reasonable assur- the Commissioner has determined is ance of the safety and effectiveness of sufficient evidence from which to dea device under its conditions of use. termine the effectiveness of a device, The evidence required may vary ac- even in the absence of well-controlled cording to the characteristics of the investigations. The Commissioner may device, its conditions of use, the exist- make such a determination where the

are

requirement of well-controlled investigations in paragraph (f) of this section is not reasonably applicable to the device.

(1) The following principles have been developed over a period of years and are recognized by the scientific community as the essentials of a well-controlled clinical investigation. They provide the basis for the Commissioner's determination whether there is reasonable assurance that a device is effective based upon well-controlled investigations and are also useful in assessing the weight to be given to other valid scientific evidence permitted under this section.

(1) The plan or protocol for the study and the report of the results of a wellcontrolled investigation shall include the following:

(i) A clear statement of the objectives of the study;

(ii) A method of selection of the subjects that:

(a) Provides adequate assurance that the subjects are suitable for the purposes of the study, provides diagnostic criteria of the condition to be treated or diagnosed, provides confirmatory laboratory tests where appropriate and, in the case of a device to prevent a disease or condition, provides evidence of susceptibility and exposure to the condition against which prophylaxis is desired;

(6) Assigns the subjects to test groups, if used, in such a way as to minimize any possible bias;

(c) Assures comparability between test groups and any control groups of pertinent variables such as sex, severity or duration of the disease, and use of therapy other than the test device;

(iii) An explanation of the methods of observation and recording of results utilized, including the variables measured, quantitation, assessment of any subject's response, and steps taken to minimize any possible bias of subjects and observers;

(iv) A comparison of the results of treatment or diagnosis with a control in such a fashion as to permit quantitative evaluation. The precise nature of the control must be specified and an explanation provided of the methods employed to minimize any possible bias of the observers and analysts of

the data. Level and methods of "blinding,” if appropriate and used, are to be documented. Generally, four types of comparisons are recognized:

(a) No treatments. Where objective measurements of effectiveness available and placebo effect is negligible, comparison of the objective results in comparable groups of treated and untreated patients;

(6) Placebo control. Where there may be a placebo effect with the use of a device, comparison of the results of use of the device with an ineffective device used under conditions designed to resemble the conditions of use under investigation as far as possible;

(c) Active treatment control. Where an effective regimen of therapy may be used for comparison, e.g., the condition being treated is such that the use of a placebo or the withholding of treatment would be inappropriate or contrary to the interest of the patient;

(d) Historical control. In certain circumstances, such as those involving diseases with high and predictable mortality or signs and symptoms of predictable duration or severity, or in the case of prophylaxis where morbidity is predictable, the results of use of the device may be compared quantitatively with prior experience historically derived from the adequately documented natural history of the disease or condition in comparable patients or populations who received no treatment or who followed an established effective regimen (therapeutic, diagnostic, prophylactic).

(v) A summary of the methods of analysis and an evaluation of the data derived from the study, including any appropriate statistical methods utilized.

(2) To insure the reliability of the results of an investigation, a well-controlled investigation shall involve the use of a test device that is standardized in its composition or design and performance.

(g)(1) It is the responsibility of each manufacturer and importer of a device to assure that adequate, valid scientific evidence exists, and to furnish such evidence to the Food and Drug Administration to provide reasonable assurance that the device is safe and effective for its intended uses and conditions of use. The failure of a manufacturer or importer of a device to present to the Food and Drug Administration adequate, valid scientific evidence showing that there is reasonable assurance of the safety and effectiveness of the device, if regulated by general controls alone, or by general controls and performance standards, may support a determination that the device be classified into class III.

(2) The Commissioner may require that a manufacturer, importer, or distributor make reports or provide other information bearing on the classification of a device and indicating whether there is reasonable assurance of the safety and effectiveness of the device or whether it is adulterated or misbranded under the act.

(3) A requirement for a report or other information under this paragraph will comply with section 519 of the act. Accordingly, the requirement will state the reason or purpose for such request; will describe the required report or information as clearly as possible; will not be imposed on a manufacturer, importer, or distributor of a classified device that has been exempted from such a requirement in accordance with $ 860.95; will prescribe the time for compliance with the requirement; and will prescribe the form and manner in which the report or information is to be provided.

(4) Required information that has been submitted previously to the Center for Devices and Radiological Health need not be resubmitted, but may be incorporated by reference. (43 FR 32993, July 28, 1978, as amended at 53 FR 11253, Apr. 6, 1988)

approval), depending upon the level of regulatory control required to provide reasonable assurance of the safety and effectiveness of the device (8 860.3(c)). This subpart does not apply to a device that is classified into class III by statute under section 513(f) of the act because the Food and Drug Administration has determined that the device is not "substantially equivalent” to any device subject to this subpart or under section 520(1) (1) through (3) of the act because the device was regarded previously as a new drug. In classifying a device under this section, the Food and Drug Administration will follow the procedures described in paragraphs (b) through (g) of this section.

(b) The Commissioner refers the device to the appropriate classification panel organized and operated in accordance with section 513 (b) and (c) of the act and part 14 of this chapter.

(c) In order to make recommendations to the Commissioner on the class of regulatory control (class I, class II, or class III) appropriate for the device, the panel reviews the device for safety and effectiveness. In so doing, the panel:

(1) Considers the factors set forth in $ 860.7 relating to the determination of safety and effectiveness;

(2) Determines the safety and effectiveness of the device on the basis of the types of scientific evidence set forth in $ 860.7;

(3) Answers the questions in the classification questionnaire applicable to the device being classified;

(4) Completes a supplemental data sheet for the device;

(5) Provides, to the maximum extent practicable, an opportunity for interested persons to submit data and views on the classification of the device in accordance with part 14 of this chapter.

(d) Based upon its review of evidence of the safety and effectiveness of the device, and applying the definition of each class in $ 860.3(c), the panel submits to the Commissioner ommendation regarding the classification of the device. The recommendation will include:

(1) A summary of the reasons for the recommendation;

(2) A summary of the data upon which the recommendation is based,

Subpart B-Classification

a

rec

$860.84 Classification procedures for

"old devices." (a) This subpart sets forth the procedures for the original classification of a device that either was in commercial distribution before May 28, 1976, or is substantially equivalent to a device that was in commercial distribution before that date. Such a device will be classified by regulation into either class I (general controls), class II (special controls) or class III (premarket

accompanied by references to the (1) If classifying the device into class sources containing such data;

I, prescribe which, if any, of the re(3) An identification of the risks to quirements of sections 510, 519, and health (if any) presented by the device; 520(f) of the act will not apply to the

(4) In the case of a recommendation device and state the reasons for makfor classification into class I, a rec- ing the requirements inapplicable, in ommendation as to whether the device accordance with $860.95; should be exempted from the require- (2) If classifying the device into class ments of one or more of the following II or class III, at the discretion of the sections of the act: section 510 (reg- Commissioner, establish priorities for istration, product listing, and pre- the application to the device of a permarket notification) section

519 formance standard or a premarket ap(records and reports) and section 520(f)

proval requirement; (good manufacturing practice regula

(3) If classifying an implant, or lifetions) in accordance with 8860.95;

supporting or life-sustaining device, (5) In the case of a recommendation

comply with $ 860.93(b). for classification into class II or class III, to the extent practicable, a rec

[43 FR 32993, July 28, 1978, as amended at 57 ommendation for the assignment to

FR 58404, Dec. 10, 1992; 64 FR 404, Jan. 5, 1999) the device of a priority for the applica

$ 860.93 Classification of implants, lifetion of a performance standard or a

supporting or life-sustaining depremarket approval requirement;

vices. (6) In the case of a recommendation for classification of an implant or a

(a) The classification panel will reclife-supporting or life-sustaining device

ommend classification into class III of into class I or class II, a statement of

any implant or life-supporting or lifewhy premarket approval is not nec

sustaining device unless the panel deessary to provide reasonable assurance

termines that such classification is not of the safety and effectiveness of the

necessary to provide reasonable assurdevice, accompanied by references to

ance of the safety and effectiveness of supporting documentation and data

the device. If the panel recommends satisfying the requirements of $ 860.7,

classification reclassification of and an identification of the risks to

such a device into a class other than health, if any, presented by the device.

class III, it shall set forth in its rec(e) A panel recommendation is re

ommendation the reasons for so doing garded as preliminary until the Com

together with references to supporting missioner has reviewed it, discussed it

documentation and data satisfying the with the panel if appropriate, and pub

requirements of $860.7, and an identilished a proposed regulation classifying

fication of the risks to health, if any, the device. Preliminary panel

presented by the device. ommendations are filed in the Dockets (b) The Commissioner will classify an Management Branch's office upon re- implant or life-supporting or life-susceipt and are available to the public taining device into class III unless the upon request.

Commissioner determines that such (f) The Commissioner publishes the

classification is not necessary to propanel's recommendation in the FED- vide reasonable assurance of the safety ERAL REGISTER, together with a pro

and effectiveness of the device. If the posed regulation classifying the device, Commissioner proposes to classify or and other devices of that generic type, reclassify such a device into a class and provides interested persons an op

other than class III, the regulation or portunity to submit comments on the order effecting such classification or recommendation and proposed regula- reclassification will be accompanied by tion.

a full statement of the reasons for so (g) The Commissioner reviews the doing. A statement of the reasons for comments and issues a final regulation not classifying or retaining the device classifying the device and other devices in class III may be in the form of conof that generic type. The regulation currence with the reasons for the recwill:

ommendation of the classification

or

rec

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