Lapas attēli
PDF
ePub

that generic type. Accordingly, a petition for the reclassification of a specific device will be considered a petition for reclassification of all substantially equivalent devices within the same generic type.

(c) Any interested person may submit a petition for reclassification under section 513(e), 514(b), or 515(b). A manufacturer or importer may submit a petition for reclassification under section 513(f) or 520(1). The Commissioner may initiate the reclassification of a device classified into class III under sections 513(f) and 520(1) of the act.

panel, together with supporting documentation and data satisfying the requirements of 8860.7 and an identification of the risks to health, if any, presented by the device. $ 860.95 Exemptions from sections 510,

519, and 520(f) of the act. (a) A panel recommendation to the Commissioner that a device be classified or reclassified into class I will include a recommendation as to whether the device should be exempted from some or all of the requirements of one or more of the following sections of the act: Section 510 (registration, product listing and premarket notification), section 519 (records and reports), and section 520(f) (good manufacturing practice regulations). (b) A regulation

order classifying or reclassifying a device into class I will specify which requirements, if any, of sections 510, 519, and 520(f) of the act the device is to be exempted from, together with the reasons for such exemption.

(C) The Commissioner will grant exemptions under this section only if the Commissioner determines that the requirements from which the device is exempted are not necessary to provide reasonable assurance of the safety and effectiveness of the device.

(43 FR 32993, July 28, 1978, as amended at 57 FR 58404, Dec. 10, 1992)

or

an

Subpart C-Reclassification

8 860.120 General.

(a) Sections 513(e) and (f), 514(b), 515(b), and 520(1) of the act provide for reclassification of a device and prescribe the procedures to be followed to effect reclassification. The purposes of subpart C are to:

(1) Set forth the requirements as to form and content of petitions for reclassification;

(2) Describe the circumstances in which each of the five statutory reclassification provisions applies; and

(3) Explain the procedure for reclassification prescribed in the five statutory reclassification provisions.

(b) The criteria for determining the proper class for a device are set forth in $860.3(c). The reclassification of any device within a generic type of device causes the reclassification of all substantially equivalent devices within

8 860.123 Reclassification petition:

Content and form. (a) Unless otherwise provided in writing by the Commissioner, any petition for reclassification of a device, regardless of the section of the act under which it is filed, shall include the following:

(1) A specification of the type of device for which reclassification requested;

(2) A statement of the action requested by the petitioner, e.g., "It is requested that device(s) be reclassified from class III to a class II”;

(3) A completed supplemental data sheet applicable to the device for which reclassification is requested;

(4) A completed classification questionnaire applicable to the device for which reclassification is requested;

(5) A statement of the basis for disagreement with the present classification status of the device;

(6) A full statement of the reasons, together with supporting data satisfying the requirements of $ 860.7, why the device should not be classified into its present classification and how the proposed classification will provide reasonable assurance of the safety and effectiveness of the device;

(7) Representative data and information known by the petitioner that are unfavorable to the petitioner's position;

(8) If the petition is based upon new information under section 513(e), 514(b), or 515(b) of the act, a summary of the new information;

not substantially equivalent device (“new device"), in consulting with the panel the Commissioner will obtain a recommendation that includes the information described in 8 860.84(d). In consulting with a panel about a petition submitted under $860.130, 8 860.132, or $860.136, the Commissioner may or may not obtain a formal recommendation.

(9) Copies of source documents from which new information used to support the petition has been obtained (attached as appendices to the petition).

(10) A financial certification or disclosure statement or both as required by part 54 of this chapter.

(b) Each petition submitted pursuant to this section shall be:

(1) Addressed to the Food and Drug Administration, Center for Devices and Radiological Health, Regulations Staff (HFZ-215), 1350 Piccard Dr., Rockville, MD 20857;

(2) Marked clearly with the section of the act under which the petition is being submitted, i.e., “513(e)," "513(f),” “514(b),” “515(b),” or “520(1) Petition”;

(3) Bound in a volume or volumes, where necessary; and

(4) Submitted in an original and two copies. [43 FR 32993, July 28, 1978, as amended at 49 FR 14505, Apr. 12, 1984; 53 FR 11253, Apr. 6, 1988; 55 FR 11169, Mar. 27, 1990; 63 FR 5254, Feb. 2, 1998; 65 FR 17137, Mar. 31, 2000]

9

8860.125 Consultation with panels.

(a) When the Commissioner is required to refer a reclassification petition to a classification panel for its recommendation under $860.134, or is required, or chooses, to consult with a panel concerning a reclassification petition, such as under $860.130, $ 860.132, or $ 860.136, the Commissioner will distribute a copy of the petition, or its relevant portions, to each panel member and will consult with the panel in one of the following ways:

(1) Consultation by telephone with at least a majority of current voting panel members and, when possible, nonvoting panel members;

(2) Consultation by mail with at least a majority of current voting panel members and, when possible, nonvoting panel members; and

(3) Discussion at a panel meeting.

(b) The method of consultation chosen by the Commissioner will depend upon the importance and complexity of the subject matter involved and the time available for action. When time and circumstances permit, the Commissioner will consult with a panel through discussion at a panel meeting.

(c) When a petition is submitted under $860.134 for a post-enactment,

$ 860.130 General procedures under

section 513(e) of the act. (a) Section 513(e) of the act applies to reclassification proceedings under the act based upon new information.

(b) A proceeding to reclassify a device under section 513(e) may be initiated:

(1) On the initiative of the Commissioner alone;

(2) On the initiative of the Commissioner in response to a request for change in classification based upon new information, under section 514(b) or 515(b) of the act (see $ 860.132); or

(3) In response to the petition of an interested person, based upon new information, filed in accordance with 8 860.123.

(c) By regulation promulgated under this section, the Commissioner may change the classification from class III into:

(1) Class II if the Commissioner determines that special controls in addition to general controls would provide reasonable assurance of the safety and effectiveness of the device and there is sufficient information to establish special controls to provide assurance; or

(2) Class I if the Commissioner determines that general controls would provide reasonable assurance of the safety and effectiveness of the device.

(d) The rulemaking procedures in $10.40 of this chapter apply to proceedings to reclassify a device under section 513(e), except that the Commissioner may secure a recommendation with respect to a proposed reclassification from the classification panel to which the device was last referred. The panel will consider a proposed reclassification submitted to it by the Commissioner in accordance with the consultation procedures of $ 860.125. Any recommendation submitted to the

Commissioner by the panel will be pub- (1) Within 15 days after publication of lished in the FEDERAL REGISTER when the Commissioner's notice referred to the Commissioner promulgates a regu- in paragraph (a) of this section, an inlation under this section.

terested person files a petition for re(e) Within 180 days after the filing of classification in accordance with a petition for reclassification under 860.123. this section, the Commissioner, by (2) The Commissioner consults with order published in the FEDERAL REG- the appropriate classification panel ISTER, will either deny the petition or

with regard to the petition in accordgive notice of his intent to initiate a

ance with $ 860.125. change in the classification of the de

(3) Within 60 days after publication of vice.

the notice referred to in paragraph (a) (f) If a device is reclassified under

of this section, the Commissioner, by this section, the regulation effecting

order published in the FEDERAL REGthe reclassification may revoke any

ISTER, either denies the petition or special control or premarket approval

gives notice of his intent to initiate a requirement that previously applied to

change in classification in accordance the device but that is no longer appli

with $ 860.130. cable because of the change in classification.

$860.134 Procedures for “new devices" (g) A regulation under this section under section 513(f) of the act and changing the classification of a device reclassification of certain devices. from class III to class II may provide

(a) Section 513(f)(2) of the act applies that such classification will not take effect until the effective date of a spe

to proceedings for reclassification of a

device currently in class III by opercial control for the device established

ation of section 513(f)(1) of the act. This under section 514 of the act.

category includes any device that is to (43 FR 32993, July 28, 1978, as amended at 57 be first introduced or delivered for inFR 58404, Dec. 10, 1992)

troduction into interstate commerce

for commercial distribution after May $ 860.132 Procedures when the Com

28, 1976, unless: missioner initiates a performance standard or premarket approval

(1) It is substantially equivalent to proceeding under section 514(b) or

another device that was in commercial 515(b) of the act.

distribution before that date and had

not been regulated before that date as (a) Sections 514(b) and 515(b) of the act require the Commissioner to pro

a new drug; or vide, by notice in the FEDERAL REG

(2) It is substantially equivalent to ISTER, an opportunity for interested

another device that was not in com

mercial distribution before such date parties to request a change in the clas

but which has been classified into class sification of a device based upon new information relevant to its classifica

I or class II; or tion when the Commissioner initiates a

(3) The Commissioner has classified proceeding either to develop a perform

the device into class I or class II in reance standard for the device if in class sponse to a petition for reclassification II, or to promulgate a regulation re

under this section. quiring premarket approval for the de- The Commissioner determines whether vice if in class III. In either case, if the a device is "substantially equivalent” Commissioner agrees that the new in- for purposes of the application of this formation warrants a change in classi- section. If a manufacturer or importer fication, the Commissioner will publish believes that a device is not "substanin the FEDERAL REGISTER notice of the tially equivalent” but that it should Commissioner's intent to initiate a not be in class III under the criteria in proceeding under section 513(e) of the 8 860.3(c), the manufacturer or importer act and $860.130 to effect such a change. may petition for reclassification under

(b) The procedures for effecting a this section. A manufacturer or imchange in classification under sections porter who believes that a device is 514(b) and 515(b) of the act are as fol- “substantially equivalent” and wishes lows:

to proceed to market the device shall

more than 210 days after the date the petition was filed), the Commissioner denies or approves the petition by order in the form of a letter to the petitioner. If the Commissioner approves the petition, the order will classify the device into class I or class II in accordance with the criteria set forth in $ 860.3(c) and subject to the applicable requirements of $860.93, relating to the classification of implants, life-supporting or life-sustaining devices, and $860.95, relating to exemptions from certain requirements of the act.

(7) Within a reasonable time after issuance of an order under this section, the Commissioner announces the order by notice published in the FEDERAL REGISTER.

[43 FR 32993, July 28, 1978, as amended at 57 FR 58404, Dec. 10, 1992)

submit a premarket notification in accordance with part 807 of this chapter. After considering a premarket notification, the Commissioner will determine whether the device is “substantially equivalent" and will notify the manufacturer or importer of such determination in accordance with part 807 of this chapter.

(b) The procedures for effecting reclassification under section 513(f) of the act are as follows:

(1) The manufacturer or importer of the device petitions for reclassification of the device in accordance with $ 860.123.

(2) Within 30 days after the petition is filed, the Commissioner notifies the petitioner of any deficiencies in the petition that prevent the Commissioner from making a decision on it and allows the petitioner to supplement a deficient petition. Within 30 days after any supplemental material is received, the Commissioner notifies the petitioner whether the petition, as supplemented, is adequate for review.

(3) After determining that the petition contains

no deficiencies precluding a decision on it, the Commissioner may for good cause shown refer the petition to the appropriate classification panel for its review and recommendation whether to approve or deny the petition.

(4) Within 90 days after the date the petition is referred to the panel, following the review procedures set forth in $ 860.84(c) for the original classification of an “old” device, the panel submits to the Commissioner its recommendation containing the information set forth in 860.84(d). A panel recommendation is regarded as preliminary until the Commissioner has reviewed it, discussed it with the panel, if appropriate, and developed a proposed reclassification order. Preliminary panel recommendations are filed in the Dockets Management Branch upon receipt and are available to the public upon request.

(5) The panel recommendation is published in the FEDERAL REGISTER as soon as practicable and interested persons are provided an opportunity to comment on the recommendation.

(6) Within 90 days after the panel's recommendation is received and no

as

8860.136 Procedures for transitional

products under section 520(I) of the

act. (a) Section 520(1)(2) of the act applies to reclassification proceedings initiated by a manufacturer or importer for reclassification of a device currently in class III by operation of section 520(1)(1) of the act. This section applies only to devices that the Food and Drug Administration regarded

"new drugs" before May 28, 1976.

(b) The procedures for effecting reclassification under section 520(1) are as follows:

(1) The manufacturer or importer of the device files a petition for reclassification of the device in accordance with 8 860.123.

(2) Within 30 days after the petition is filed, the Commissioner notifies the petitioner of any deficiencies in the petition that prevent the Commissioner from making a decision on it, allowing the petitioner to supplement a deficient petition. Within 30 days after any supplemental material is received, the Commissioner notifies the petitioner whether the petition, as supplemented, is adequate for review.

(3) The Commissioner provides the petitioner an opportunity for a regulatory hearing conducted in accordance with part 16 of this chapter.

(4) The Commissioner consults with the appropriate classification panel with regard to the petition in accordance with 8 860.125.

(5) Within 180 days after the petition is filed (where the Commissioner has determined it to be adequate for review), the Commissioner, by order in the form of a letter to the petitioner, either denies the petition or classifies the device into class I or class II in accordance with the criteria set forth in $ 860.3(c).

(6) Within a reasonable time after issuance of an order under this section, the Commissioner announces the order by notice published in the FEDERAL REGISTER.

reasonable assurance of the safety and effectiveness of the device. Performance standards may be established for:

(1) A class II device;

(2) A class III device which, upon the effective date of the standard, is reclassified into class II; and

(3) A class III device, as a condition to premarket approval under section 515 of the act, to reduce or eliminate a risk or risks associated with such device.

(c) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.

PART 861-PROCEDURES FOR PER

FORMANCE STANDARDS DEVELOPMENT

[45 FR 7484, Feb. 1, 1980, as amended at 45 FR 23686, Apr. 8, 1980; 57 FR 58404, Dec. 10, 1992)

Subpart A-General Sec. 861.1 Purpose and scope. 861.5 Statement of policy. 861.7 Contents of standards.

Subpart B-Procedures for Pertormance Standards Development and Publication 861.20 Summary of standards development

process. 861.24 Existing standard

proposed standard. 861.30 Development of standards. 861.34 Amendment or revocation of a stand

ard. 861.36 Effective dates. 861.38 Standards advisory committees.

AUTHORITY: 21 U.S.C. 351, 352, 3600, 3600, 360gg-360ss, 371, 374; 42 U.S.C. 262, 264.

SOURCE: 45 FR 7484, Feb. 1, 1980, unless otherwise noted.

$ 861.5 Statement of policy.

In carrying out its duties under this section, the Food and Drug Administration will, to the maximum extent practical:

(a) Use personnel, facilities, and other technical support available in other Federal agencies;

(b) Consult with other Federal agencies concerned with standard setting and other nationally or internationally recognized standard-setting entities; and

(c) Invite participation, through conferences, workshops, or other means, by representatives of scientific, professional, industry, or consumer organizations who can make a significant contribution.

as

a

Subpart A-General

$861.1 Purpose and scope.

(a) This part implements section 514 of the Federal Food, Drug, and Cosmetic Act (the act) with respect to the establishment, amendment, and revocation of performance standards applicable to devices intended for human use.

(b) The Food and Drug Administration may determine that a performance standard, as described under special controls for class II devices in $860.7(b) of this chapter, is necessary to provide

$ 861.7 Contents of standards.

Any performance standard established under this part will include such provisions as the Food and Drug Administration determines are necessary to provide reasonable assurance of the safety and effectiveness of the device or devices for which it is established. Where necessary to provide such assurance, a standard will address (but need not be limited to):

(a) Performance characteristics of the device;

(b) The design, construction, components, ingredients, and properties of the device, and its compatibility with power systems and connections to such systems;

« iepriekšējāTurpināt »