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(vii) The name, address, and tele- (d) When a manufacturer becomes phone number of the prescribing physi- aware that a distributor, final discian; and

tributor, or multiple distributor has (viii) If and when applicable, the date not collected, maintained, or furnished the device was returned to the manu- any record or information required by facturer, permanently retired from use, this part, the manufacturer shall noor otherwise permanently disposed of.

tify the FDA district office responsible (b) A manufacturer of a tracked de- for the area in which the distributor, vice shall keep current records in ac

final distributor, or multiple discordance with its standard operating

tributor is located of the failure of procedure of the information identified such persons to comply with the rein paragraphs (a)(1), (a)(2) and (a)(3)(1) quirements of this part. Manufacturers through (a)(3)(iii) of this section on

shall have taken reasonable steps to each tracked device released for dis- obtain compliance by the distributor, tribution for as long as such device is

multiple distributor, final disin use or in distribution for use.

tributor in question before notifying (C) A manufacturer of a tracked de

FDA. vice shall establish a written standard

(e) A manufacturer may petition for operating procedure for the collection,

an exemption or variance from one or maintenance, and auditing of the data

more requirements of this part accordspecified in paragraphs (a) and (b) of

ing to the procedures in $821.2 of this this section. A manufacturer shall

chapter. make this standard operating procedure available to FDA upon request. A

Subpart C-Additional manufacturer shall incorporate the fol- Requirements and Responsibilities lowing into the standard operating procedure:

8821.30 Tracking obligations of per(1) Data collection and recording pro

sons other than device manufacturcedures, which shall include a proce

ers: distributor requirements. dure for recording when data which is (a) A distributor, final distributor, or required under this part is missing and multiple distributor of any tracked decould not be collected and the reason vice shall, upon purchasing or otherwhy such required data is missing and wise acquiring any interest in such a could not be collected;

device, promptly provide the manufac(2) A method for recording all modi- turer tracking the device with the folfications or changes to the tracking lowing information: system or to the data collected and (1) The name and address of the dismaintained under the tracking system,

tributor, final distributor or multiple reasons for any modification or change, distributor; and dates of any modification

(2) The lot number, batch number, change. Modification and changes in- model number, or serial number of the cluded under this requirement include device or other identifier used by the modifications to the data (including manufacturer to track the device; termination of tracking), the data for- (3) The date the device was received; mat, the recording system, and the file (4) The person from whom the device maintenance procedures system; and was received;

(3) A quality assurance program that (5) If and when applicable, the date includes an audit procedure to be run the device was explanted, the date of for each device product subject to the patient's death, or the date the detracking, at not less than 6-month in- vice was returned to the distributor, tervals for the first 3 years of distribu- permanently retired from use, or othertion and at least once a year there- wise permanently disposed of. after. This audit procedure shall pro- (b) A final distributor, upon sale or vide for statistically relevant sampling other distribution of a tracked device of the data collected to ensure the ac- for use in or by the patient, shall curacy of data and performance testing promptly provide the manufacturer of the functioning of the tracking sys- tracking the device with the following tem.

information:

or

days of a request from FDA for the information identified in paragraph (c)(1) of this section, provide such information to the manufacturer or FDA.

(d) A distributor, final distributor, or multiple distributor shall make any records required to be kept under this part available to the manufacturer of the tracked device for audit upon written request by an authorized representative of the manufacturer.

(e) A distributor, final distributor, or multiple distributor may petition for an exemption or variance from one or more requirements of this part according to the procedures in $ 821.2.

(1) The name and address of the final distributor,

(2) The lot number, batch number, model number, or serial number of the device or other identifier used by the manufacturer to track the device;

(3) The name, address, telephone number, and social security number (if available) of the patient receiving the device;

(4) The date the device was provided to the patient or for use in the patient;

(5) The name, mailing address, and telephone number of the prescribing physician;

(6) The name, mailing address, and telephone number of the physician regularly following the patient if different than the prescribing physician; and

(7) When applicable, the date the device was explanted and the name, mailing address, and telephone number of the explanting physician, the date of the patient's death, or the date the device was returned to the manufacturer, permanently retired from use, or otherwise permanently disposed of.

(c)(1) A multiple distributor shall keep written records of the following each time such device is distributed for use by a patient:

(i) The lot number, batch number, or model number, or serial number of the device or other identifier used by the manufacturer to track the device;

(ii) The name, address, telephone number, and social security number (if available) of the patient using the device;

(iii) The location of the device;

(iv) The date the device was provided for use by the patient;

(v) The name, address, and telephone number of the prescribing physician;

(vi) The name, address, and telephone number of the physician regularly following the patient if different than the prescribing physician; and

(vii) When applicable, the date the device was permanently retired from use or otherwise permanently disposed of.

(2) Except as required by order under section 518(e) of the act, any person who is a multiple distributor subject to the recordkeeping requirement of paragraph (c)(1) of this section shall, within 5 working days of a request from the manufacturer or within 10 working

Subpart D-Records and

Inspections $821.50 Availability.

(a) Manufacturers, distributors, multiple distributors, and final distributors shall, upon the presentation by an FDA representative of official credentials and the issuance of Form FDA 482 at the initiation of an inspection of an establishment or person under section 704 of the act, make each record and all information required to be collected and maintained under this part and all records and information related to the events and persons identified in such records available to FDA personnel.

(b) Records and information referenced in paragraph (a) of this section shall be available to FDA personnel for purposes of reviewing, copying, or any other use related to the enforcement of the act and this part. Records required to be kept by this part shall be kept in a centralized point for each manufacturer or distributor within the United States.

(58 FR 43447, Aug. 16, 1993, as amended at 65 FR 43690, July 14, 2000)

$821.55 Confidentiality.

(a) Records and other information submitted to FDA under this part shall be protected from public disclosure to the extent permitted under part 20 of this chapter, and in accordance with $20.63 of this chapter, information contained in such records that would identify patient or research subjects shall not be available for public disclosure except as provided in those parts.

market approval proceeding under sec

tion 514(b) or 515(b) of the act. 860.134 Procedures for "new devices” under

section 513(f) of the act and reclassifica

tion of certain devices. 860.136 Procedures for transitional products

under section 520(1) of the act. AUTHORITY: 21 U.S.C. 360c, 3600, 360e, 360i, 360j, 371, 374.

SOURCE: 43 FR 32993, July 28, 1978, unless otherwise noted.

Subpart A-General

(b) Patient names or other identifiers may be disclosed to a manufacturer or other person subject to this part or to a physician when the health or safety of the patient requires that such persons have access to the information. Such notification will be pursuant to agreement that the record or information will not be further disclosed except as the health aspects of the patient requires. Such notification does not constitute public disclosure and will not trigger the availability of the same information to the public generally. $821.60 Retention of records.

Persons required to maintain records under this part shall maintain such records for the useful life of each tracked device they manufacture or distribute. The useful life of a device is the time a device is in use or in distribution for use. For example, a record may be retired if the person maintaining the record becomes aware of the fact that the device is no longer in use, has been explanted, returned to the manufacturer, or the patient has died.

PART 860-MEDICAL DEVICE CLASSIFICATION PROCEDURES

Subpart A-General

Sec. 860.1 Scope. 860.3 Definitions. 860.5 Confidentiality and use of data and in

formation submitted in connection with

classification and reclassification. 860.7 Determination of safety and effective

ness.

8860.1 Scope.

(a) This part implements sections 513, 514(b), 515(b), and 520(1) of the act with respect to the classification and reclassification of devices intended for human use.

(b) This part prescribes the criteria and procedures to be used by classification panels in making their recommendations and by the Commissioner in making the Commissioner's determinations regarding the class of regulatory control (class I, class II, or class III) appropriate for particular devices. Supplementing the general Food and Drug Administration procedures governing advisory committees (part 14 of this chapter), this part also provides procedures for manufacturers, importers, and other interested persons to participate in proceedings to classify and reclassify devices. This part also describes the kind of data required for determination of the safety and effectiveness of a device, and the circumstances under which information submitted to classification panels or to the Commissioner in connection with classification and reclassification proceedings will be available to the public. $ 860.3 Definitions.

For the purposes of this part:

(a) Act means the Federal Food, Drug, and Cosmetic Act.

(b) Commissioner means the Commissioner of Food and Drugs, Food and Drug Administration, United States Department of Health and Human Services, or the Commissioner's designee.

(c) Class means one of the three categories of regulatory control for medical devices, defined below:

Subpart B-Classification 860.84 Classification procedures for “old de

vices." 860.93 Classification of implants, life-sup

porting or life-sustaining devices. 860.95 Exemptions from sections 510, 519,

and 520(1) of the act.

Subpart C-Reclassification 860.120 General. 860.123 Reclassification petition: Content

and form. 860.125 Consultation with panels. 860.130 General procedures under section

513(e) of the act. 860.132 Procedures when the Commissioner

initiates a performance standard or pre

(1) Class I means the class of devices application of special controls dethat are subject to only the general scribed in paragraph (c)(2) of this seccontrols authorized by or under sec- tion would provide such assurance and tions 501 (adulteration), 502 (mis- if, in addition, the device is life-supbranding), 510 (registration), 516 porting or life-sustaining, or for a use (banned devices), 518 (notification and which is of substantial importance in other remedies), 519 (records and re- preventing impairment of human ports), and 520 (general provisions) of health, or if the device presents a pothe act. A device is in class I if (i) gen- tential unreasonable risk of illness or eral controls are sufficient to provide injury. reasonable assurance of the safety and

(d) Implant means a device that is effectiveness of the device, or (ii) there placed into a surgically or naturally is insufficient information from which

formed cavity of the human body. A deto determine that general controls are vice is regarded as an implant for the sufficient to provide reasonable assur

purpose of this part only if it is inance of the safety and effectiveness of

tended to remain implanted continuthe device or to establish special con- ously for a period of 30 days or more, trols to provide such assurance, but the unless the Commissioner determines device is not life-supporting or life-sus

otherwise in order to protect human taining or for a use which is of

health. substanial importance in preventing

(e) Life-supporting or life-sustaining deimpairment of human health, and

vice means a device that is essential to, which does not present a potential un

or that yields information that is esreasonable risk of illness of injury.

sential to, the restoration or continu(2) Class II means the class of devices

ation of a bodily function important to that is or eventually will be subject to

the continuation of human life. special controls. A device is in class II

(f) Classification questionnaire means a if general controls alone are insufficient to provide reasonable assurance

specific series of questions prepared by

the Commissioner for use as guidelines of its safety and effectiveness and there is sufficient information to establish

by classification panels preparing rec

ommendations to the Commissioner respecial controls, including the promul

garding classification and by petigation of performance standards, postmarket surveillance, patient reg

tioners submitting petitions for reclas

sification. The questions relate to the istries, development and dissemination

safety and effectiveness characteristics of guidance documents (including guid

of a device and the answers are deance on the submission of clinical data in premarket notification submissions

signed to help the Commissioner deter

mine the proper classification of the in accordance with section 510(k) of the

device. act), recommendations, and other appropriate actions as the Commissioner

(g) Supplemental data sheet means indeems necessary to provide such assur

formation compiled by a classification ance. For a device that is purported or

panel or submitted in a petition for re

classification, including: represented to be for use in supporting or sustaining human life, the Commis- (1) A summary of the reasons for the sioner shall examine and identify the

recommendation (or petition); special controls, if any, that are nec

(2) A summary of the data upon essary to provide adequate assurance of

which the recommendation (or petisafety and effectiveness and describe

tion) is based; how such controls provide such assur

(3) An identification of the risks to ance.

health (if any) presented by the device; (3) Class III means the class of devices (4) To the extent practicable in the for which premarket approval is or will case of a class II or class III device, a be required in accordance with section recommendation for the assignment of 515 of the act. A device is in class III if a priority for the application of the reinsufficient information exists to de- quirements of performance standards termine that general controls are suffi- or premarket approval; cient to provide reasonable assurance (5) In the case of a class I device, a of its safety and effectiveness or that recommendation whether the device

should be exempted from any of the requirements of registration, recordkeeping and reporting, or good manufacturing practice regulations;

(6) In the case of an implant or a lifesupporting or life-sustaining device for which classification in class III is not recommended, a statement of the reasons for not recommending that the device be classified in class III;

(7) Identification of any needed restrictions on the use of the device, e.g., whether the device requires special labeling, should be banned, or should be used only upon authorization of a practitioner licensed by law to administer or use such device; and

(8) Any known existing standards applicable to the device, device components, or device materials.

(h) Classification panel means one of the several advisory committees established by the Commissioner under section 513 of the act and part 14 of this chapter for the purpose of making recommendations to the Commissioner on the classification and reclassification of devices and for other purposes prescribed by the act or by the Commissioner.

(i) Generic type of device means a grouping of devices that do not differ significantly in purpose, design, materials, energy source, function, or any other feature related to safety and effectiveness, and for which similar regulatory controls are sufficient to provide reasonable assurance of safety and effectiveness.

(j) Petition means a submission seeking reclassification of a device in accordance with $ 860.123. [43 FR 32993, July 28, 1978, as amended at 57 FR 58403, Dec. 10, 1992; 65 FR 56480, Sept. 19, 2000]

(b) In general, data and information submitted to classification panels in connection with the classification of devices under $ 860.84 will be available immediately for public disclosure upon request. However, except as provided by the special rules in paragraph (c) of this section, this provision does not apply to data and information exempt from public disclosure in accordance with part 20 of this chapter: Such data and information will be available only in accordance with part 20.

(c)(1) Safety and effectiveness data submitted to classification panels or to the Commissioner in connection with the classification of a device under $ 860.84, which have not been disclosed previously to the public, as described in $20.81 of this chapter, shall be regarded as confidential if the device is classified in to class III. Because the classification of a device under $ 860.84 may be ascertained only upon publication of a final regulation, all safety and effectiveness data that have not been disclosed previously are not available for public disclosure unless and until the device is classified into class I or II, in which case the procedure in paragraph (c)(2) of this section applies.

(2) Thirty days after publication of a final regulation under 8 860.84 classifying a device into class I or class II, safety and effectiveness data submitted for that device that had been regarded as confidential under paragraph (c)(1) of this section will be available for public disclosure and placed on public display in the office of the Dockets Management Branch, Food and Drug Administration unless, within that 30-day period, the person who submitted the data demonstrates that the data still fall within the exemption for trade secrets and confidential commercial information described in $20.61 of this chapter. Safety and effectiveness data submitted for a device that is classified into class III by regulation in accordance with $860.84 will remain confidential and unavailable for public disclosure so long as such data have not been disclosed to the public as described in $ 20.81 of this chapter.

(3) Because device classification affects generic types of devices, in making determinations under $860.84 concerning the initial classification of a

$ 860.5 Confidentiality and use of data

and information submitted in connection with classification and re

classification. (a) This section governs the availability for public disclosure and the use by the Commissioner of data and information submitted to classification panels or to the Commissioner in connection with the classification or reclassification of devices under this part.

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