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(5) The nature and details of the complaint;

(6) The dates and results of the inves. tigation;

(7) Any corrective action taken; and (8) Any reply to the complainant.

(f) When the manufacturer's formally designated complaint unit is located at a site separate from the manufacturing establishment, the investigated complaint(s) and the record(s) of investigation shall be reasonably accessible to the manufacturing establishment.

(g) If a manufacturer's formally designated complaint unit is located outside of the United States, records required by this section shall be reasonably accessible in the United States at either:

(1) A location in the United States where the manufacturer's records are regularly kept; or

(2) The location of the initial distributor.

(1) All complaints are processed in a uniform and timely manner;

(2) Oral complaints are documented upon receipt; and

(3) Complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under part 803 or 804 of this chapter, Medical Device Reporting.

(b) Each manufacturer shall review and evaluate all complaints to determine whether an investigation is necessary. When no investigation is made, the manufacturer shall maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate.

(c) Any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications shall be reviewed, evaluated, and investigated, unless such investigation has already been performed for a similar complaint and another investigation is not necessary.

(d) Any complaint that represents an event which must be reported to FDA under part 803 or 804 of this chapter shall be promptly reviewed, evaluated, and investigated by a designated individual(s) and shall be maintained in a separate portion of the complaint files or otherwise clearly identified. In addition to the information required by $ 820.198(e), records of investigation under this paragraph shall include a determination of:

(1) Whether the device failed to meet specifications;

(2) Whether the device was being used for treatment or diagnosis; and

(3) The relationship, if any, of the device to the reported incident or adverse event.

(e) When an investigation is made under this section, a record of the investigation shall be maintained by the formally designated unit identified in paragraph (a) of this section. The record of investigation shall include:

(1) The name of the device;

(2) The date the complaint was received;

(3) Any device identification(s) and control number(s) used;

(4) The name, address, and phone number of the complainant;

Subpart N-Servicing 8 820.200 Servicing.

(a) Where servicing is a specified requirement, each manufacturer shall establish and maintain instructions and procedures for performing and verifying that the servicing meets the specified requirements.

(b) Each manufacturer shall analyze service reports with appropriate statistical methodology in accordance with $ 820.100.

(c) Each manufacturer who receives a service report that represents an event which must be reported to FDA under part 803 or 804 of this chapter shall automatically consider the report a complaint and shall process it in accordance with the requirements of 8820.198.

(d) Service reports shall be documented and shall include:

(1) The name of the device serviced;

(2) Any device identification(s) and control number(s) used;

(3) The date of service;

(4) The individual(s) servicing the device;

(5) The service performed; and
(6) The test and inspection data.

Subpart 0—Statistical Techniques

od of device tracking by any person

who registers under section 510 of the $820.250 Statistical techniques.

act and is engaged in the manufacture (a) Where appropriate, each manufac

and distribution of devices the failure turer shall establish and maintain pro

of which would be reasonably likely to cedures for identifying valid statistical

have serious adverse health contechniques required for establishing,

sequences if the devices are life-suscontrolling, and verifying the accept

taining or life-supporting devices used ability of process capability and prod

outside of a device user facility or are uct characteristics.

permanently implantable devices. This (b) Sampling plans, when used, shall part also applies to any other device be written and based on a valid statis- that the Food and Drug Administratical rationale. Each manufacturer

tion (FDA) designates as requiring a shall establish and maintain proce

method of tracking to protect the pubdures to ensure that sampling methods

lic health. A device subject to this part are adequate for their intended use and either by statutory requirement or by to ensure that when changes occur the FDA designation is referred to herein sampling plans are reviewed. These ac- as a “tracked device." tivities shall be documented.

(b) These regulations are intended to

ensure that tracked devices can be PART 821-MEDICAL DEVICE traced from the device manufacturing TRACKING REQUIREMENTS

facility to the person for whom the de

vice is indicated, that is, the patient. Subpart A-General Provisions

Effective tracking of devices from the

manufacturing facility, through the Sec.

distributor network (including dis821.1 Scope.

tributors, retailers, rental firms and 821.2 Exemptions and variances.

other commercial enterprises, device 821.3 Definitions.

user facilities and licensed practi821.4 Imported devices.

tioners) and, ultimately, to any person Subpart B-Tracking Requirements for whom the device is intended is nec

essary for the effectiveness of remedies 821.20 Devices subject to tracking.

prescribed by the act, such as patient 821.25 Device tracking system and content requirements: manufacturer require

notification (section 518(a) of the act) ments.

or device recall (section 518(e) of the

act). Although these regulations do not Subpart c-Additional Requirements and preclude a manufacturer from involvResponsibilities

ing outside organizations in that man

ufacturer's device tracking effort, the 821.30 Tracking obligations of persons other

legal responsibility for complying with than device manufacturers: distributor requirements.

this part rests with manufacturers who

must register under section 510 of the Subpart D-Records and Inspections act, and that responsibility cannot be

altered, modified, or in any way abro821.50 Availability. 821.55 Confidentiality.

gated by contracts or other agree821.60 Retention of records.

ments.

(c) Each manufacturer of a tracked AUTHORITY: 21 U.S.C. 331, 351, 352, 360, 360e,

device shall implement a method of 360h, 360i, 371, 374.

tracking devices by August 29, 1993. SOURCE: 58 FR 43447, Aug. 16, 1993, unless (d) The primary burden for ensuring otherwise noted.

that the tracking system works rests

upon the manufacturer. A manufacSubpart A-General Provisions

turer or any other person, including a

distributor, final distributor, or mul8821.1 Scope.

tiple distributor, who distributes a de(a) The regulations in this part im- vice subject to tracking, who fails to plement section 519(e) of the Federal comply with any applicable requireFood, Drug, and Cosmetic Act (the act) ment of section 519(e) of the act or of which requires the adoption of a meth- this part, or any person who causes such failure, misbrands the device (c) An exemption or variance is not within the meaning of section 501(t)(2) effective until the Director, Office of of the act and commits a prohibited act Compliance and Surveillance, CDRH, within the meaning of sections 301(e) approves the request under and 301(q)(1)(B) of the act.

194-069 D-01--6

$10.30(e)(2)(i) of this chapter. (e) Any person subject to this part (d) For petitions received under this who permanently discontinues doing section before August 29, 1993, FDA business is required to notify FDA at will, within 60 days, approve or disthe time the person notifies any gov- approve the petition or extend the efernment agency, court, or supplier, and fective date of this part for the device provide FDA with a complete set of its that is the subject of the petition. Any tracking records and information. extension that FDA grants to the effecHowever, if a person ceases distribu- tive date will be based upon the addition of a tracked device but continues tional time FDA needs to complete its to do other business, that person con

review of the petition. tinues to be responsible for compliance

(58 FR 43447, Aug. 16, 1993, as amended at 59 with this part unless another person, FR 31138, June 17, 1994) affirmatively and in writing, assumes responsibility for continuing the track- $821.3 Definitions. ing of devices previously distributed

The following definitions and terms under this part. Further, if a person apply to this part: subject to this part goes out of busi- (a) Act means the Federal Food, ness completely, but other persons ac- Drug, and Cosmetic Act, 21 U.S.C. 321 et quire the right to manufacture or dis

seq., as amended. tribute tracked devices, those other (b) Importer means the initial dispersons are deemed to be responsible tributor of an imported device who is for continuing the tracking responsi- required to register under section 510 of bility of the previous person under this the act and $807.20 of this chapter. part.

"Importer" does not include anyone

who only performs a service for the 8821.2 Exemptions and variances.

person who furthers the marketing, (a) A manufacturer, importer, or dis- i.e., brokers, jobbers, or warehousers. tributor may seek an exemption or (c) Manufacturer means any person, variance from one or more require including any importer, repacker and ments of this part.

or relabeler, who manufactures, pre(b) A request for an exemption or pares, propagates, compounds, assemvariance shall be submitted in the form bles, or processes a device or engages in of a petition under $10.30 of this chap- any of the activities described in ter and shall comply with the require- $807.3(d) of this chapter. ments set out therein, except that a re- (d) Device failure means the failure of sponse shall be issued in 90 days. The a device to perform or function as inDirector or Deputy Directors, CDRH, tended, including any deviations from or the Director, Office of Compliance, the device's performance specifications CDRH, shall issue responses to requests or intended use. under this section. The petition shall (e) Serious adverse health consequences also contain the following:

means any significant adverse experi(1) The name of the device and device ence related to a device, including declass and representative labeling show- vice-related events which are lifeing the intended use(s) of the device; threatening or which involve perma

(2) The reasons that compliance with nent or long-term injuries or illnesses. the tracking requirements of this part (f) Permanently implantable device is unnecessary;

means a device that is intended to be (3) A complete description of alter- placed into a surgically or naturally native steps that are available, or that formed cavity of the human body to the petitioner has already taken, to en- continuously assist, restore, or replace sure that an effective tracking system the function of an organ system or is in place; and

structure of the human body through(4) Other information justifying the out the useful life of the device. The exemption or variance.

term does not include any device which is intended and used for temporary pur- (m) Any term defined in section 201 poses or which is intended for of the act shall have the same definiexplantation.

tion in this part. (g) Life-supporting of life-sustaining device used outside a device user facility

8821.4 Imported devices. means a device which is essential, or For purposes of this part, the imyields information that is essential, to porter of a tracked device shall be conthe restoration or continuation of a sidered the manufacturer and shall be bodily function important to the con- required to comply with all requiretinuation of human life that is in- ments of this part applicable to manutended for use outside a hospital, nurs- facturers. Importers must keep all ining home, ambulatory surgical facility, formation required under this part in or diagnostic or outpatient treatment the United States. facility. Physicians' offices are not device user facilities and, therefore, de- Subpart B-Tracking Requirements vices used therein are subject to tracking if they otherwise satisfy the statu- $ 821.20 Devices subject to tracking. tory and regulatory criteria.

(a) A manufacturer of any device the (h) Distributor means any person who failure of which would be reasonably furthers the distribution of a device

likely to have a serious adverse health from the original place of manufacture

consequence, that is either a life-susto the person who makes delivery or taining or life-supporting device used sale to the ultimate user, i.e., the final outside of a device user facility or a or multiple distributor, but who does

permanently implantable device, or a not repackage or otherwise change the manufacturer of any other device that container, wrapper, or labeling of the FDA, in its discretion, designates for device or device package.

tracking, shall track that device in ac(i) Final distributor means any person cordance with this part. who distributes a tracked device in- (b) Manufacturers have the responsitended for use by a single patient over bility to identify devices that meet the the useful life of the device to the pa- criteria for tracking and to initiate tient. This term includes, but is not tracking. By way of illustration and to limited to, licensed practitioners, re- provide guidance, FDA has set out tail pharmacies, hospitals, and other below a list of example devices it retypes of device user facilities.

gards as subject to tracking under the (3) Distributes means any distribution criteria set forth in this regulation. of a tracked device, including the char- (1) Permanently implantable devices. itable distribution of a tracked device.

21 CFR

Classification This term does not include the distribution of a device under an effective 870.3450 Vascular graft prosthesis of less than 6 millimeinvestigational device exemption in ac

ters diameter cordance with section 520(g) of the act

870.3460 Vascular graft prosthesis of 6 millimeters and

greater diameter and part 812 of this chapter or the dis- (no cite) Total temporomandibular joint prosthesis. tribution of a device for teaching, law (no cite) Glenoid fossa prosthesis. enforcement, research, or analysis as

(no cite) Mandibular condyle prosthesis.

(no cite) Interarticular disc prosthesis (interpositional imspecified in $ 801.125 of this chapter.

plant). (k) Multiple distributor means any de- 870.3545 Ventricular bypass (assist) device vice user facility, rental company, or

870.3610 Implantable pacemaker pulse generator

870.3680 Cardiovascular permanent pacemaker electrode any other entity that distributes a life

870.3800 Annuloplasty ring sustaining or life-supporting device in

870.3925 Replacement heart valve tended for use by more than one pa- (no cite) Automatic implantable cardioverter/defibrillator tient over the useful life of the device.

878.3720 Tracheal prosthesis

882.5820 Implanted cerebellar stimulator (1) Licensed practitioner means a phy

882.5830 Implanted diaphragmatic/phrenic nerve stimulator sician, dentist, or other health care (no cite) Implantable infusion pumps practitioner licensed by the law of the State in which he or she practices to (2) Life-sustaining or life-supporting use or order the use of the tracked de- devices used outside device user facilivice.

ties

[blocks in formation]

(d) FDA, when responding to premarket notification submissions and approving premarket approval applications, will notify the sponsor that FDA believes the device meets the criteria of section 519(e)(1) and therefore should be tracked. FDA will also, after notifying the sponsor, publish a notice in the FEDERAL REGISTER announcing that FDA believes a new generic type of device is subject to tracking and soliciting comment on FDA's position. If the device is a new generic type of device not already on the example list above, FDA will add it to this list. [58 FR 43447, Aug. 16, 1993, as amended at 58 FR 43455, Aug. 16, 1993; 59 FR 15052, Mar. 31, 1994.)

life-supporting devices used outside a device user facility that are intended for use by a single patient over the life of the device and permanent implants that are tracked devices, after distribution to or implantation in a patient:

(i) The lot number, batch number, model number, or serial number of the device or other identifier necessary to provide for effective tracking of the devices;

(ii) The date the device was shipped by the manufacturer;

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

(iv) The date the device was provided to the patient;

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

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

(vii) If 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.

(3) Except as required by order under section 518(e) within 10 working days of a request from FDA for life-sustaining or life-supporting devices used outside device user facilities that are intended for use by more than one patient and that are tracked devices, after the distribution of the device to the multiple distributor:

(i) The lot model number, batch number, serial number of the device or other identifier necessary to provide for effective tracking of the device;

(ii) The date the device was shipped by the manufacturer;

(iii) The name, address, and telephone number of the multiple distributor;

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

(v) The location of the device;

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

$ 821.25 Device tracking system and

content requirements: manufac

turer requirements. (a) A manufacturer of a tracked device shall adopt a method of tracking for each such type of device that it distributes that enables a manufacturer to provide FDA with the following information in writing for each tracked device distributed:

(1) Except as required by order under section 518(e) of the act, within 3 working days of a request from FDA, prior to the distribution of a tracked device to a patient, the name, address, and telephone number of the distributor, multiple distributor, or final distributor holding the device for distribution and the location of the device;

(2) Within 10 working days of a request from FDA for life-sustaining or

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