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(b) U.S.-designated agents of foreign (b) The following actions are exempt manufacturers are required to:

from the reporting requirements of this (1) Report to FDA in accordance with part: $$ 803.50, 803.52, 803.53, 803.55, and 803.56; (1) Actions taken by device manufac

(2) Conduct, or obtain from the for- turers or importers to improve the pereign manufacturer the necessary infor- formance or quality of a device but mation regarding, the investigation that do not reduce a risk to health and evaluation of the event to comport posed by the device or remedy a violawith the requirements of $ 803.50;

tion of the act caused by the device. (3) Certify in accordance with $ 803.57; (2) Market withdrawals as defined in

(4) Forward MDR complaints to the $806.2(h). foreign manufacturer and maintain (3) Routine servicing as defined in documentation of this requirement; $ 806.2(k).

(5) Maintain complaint files in ac- (4) Stock recoveries as defined in cordance with 8 803.18; and

8 806.2(1). (6) Register, list, and submit pre

[62 FR 27191, May 19, 1997, as amended at 63 market notifications in accordance FR 42232, Aug. 7, 1998] with part 807 of this chapter. EFFECTIVE DATE NOTE: At 61 FR 38347, July

8 806.2 Definitions. 23, 1996, § 803.58 was stayed indefinitely.

As used in this part:

(a) Act means the Federal Food, PART 806-MEDICAL DEVICES; RE Drug, and Cosmetic Act.

PORTS OF CORRECTIONS AND (b) Agency or FDA means the Food REMOVALS

and Drug Administration.

(c) Consignee means any person or Subpart A-General Provisions

firm that has received, purchased, or

used a device subject to correction or Sec.

removal. 806.1 Scope.

(d) Correction means the repair, modi806.2 Definitions.

fication, adjustment, relabeling, de

struction, or inspection (including paSubpart B-Reports and Records

tient monitoring) of a device without 806.10 Reports of corrections and removals.

its physical removal from its point of 806.20 Records of corrections and removals

use to some other location. not required to be reported.

(e) Correction or removal report number 806.30 FDA access to records.

means the number that uniquely iden806.40 Public availability of reports.

tifies each report submitted. AUTHORITY: 21 U.S.C. 352, 360, 3600, 360j, 371,

(f) Importer means, for the purposes of 374.

this part, any person who imports a de

vice into the United States. SOURCE: 62 FR 27191, May 19, 1997, unless

(g) Manufacturer means any person otherwise noted.

who manufactures, prepares, propa

gates, compounds, assembles, or procSubpart A-General Provisions

esses a device by chemical, physical,

biological, or other procedures. The 8806.1 Scope.

term includes any person who: (a) This part implements the provi (1) Repackages or otherwise changes sions of section 519(f) of the Federal the container, wrapper, or labeling of a Food, Drug, and Cosmetic Act (the act) device in furtherance of the distriburequiring device manufacturers and tion of the device from the original importers to report promptly to the place of manufacture to the person who Food and Drug Administration (FDA) makes final delivery or sale to the ulticertain actions concerning device cor- mate user or consumer; rections and removals, and to maintain (2) Initiates specifications for devices records of all corrections and removals that are manufactured by a second regardless of whether such corrections party for subsequent distribution by and removals are required to be re- the person initiating the specificaported to FDA.

tions; or

[blocks in formation]

Subpart B-Reports and Records

(3) Manufactures components or accessories which are devices that are ready to be used and are intended to be commercially distributed and are intended to be used as is, or are processed by a licensed practitioner or other qualified person to meet the needs of a particular patient.

(h) Market withdrawal means a correction or removal of a distributed device that involves a minor violation of the act that would not be subject to legal action by FDA or that involves no violation of the act, e.g., normal stock rotation practices.

(i) Removal means the physical removal of a device from its point of use to some other location for repair, modification, adjustment, relabeling, destruction, or inspection.

(j) Risk to health means

(1) A reasonable probability that use of, or exposure to, the product will cause serious adverse health consequences or death; or

(2) That use of, or exposure to, the product may cause temporary or medically reversible adverse health consequences, or an outcome where the probability of serious adverse health consequences is remote.

(k) Routine servicing means any regularly scheduled maintenance of a device, including the replacement of parts at the end of their normal life expectancy, e.g., calibration, replacement of batteries, and responses to normal wear and tear. Repairs of an unexpected nature, replacement of parts earlier than their normal life expectancy, or identical repairs or replacements of multiple units of a device are not routine servicing.

(1) Stock recovery means the correction or removal of a device that has not been marketed or that has not left the direct control of the manufacturer, i.e., the device is located on the premises owned, or under the control of, the manufacturer, and no portion of the lot, model, code, or other relevant unit involved in the corrective or removal action has been released for sale or use. (62 FR 27191, May 19, 1997, as amended at 63 FR 42232, Aug. 7, 1998]

$806.10 Reports of corrections and re

movals. (a) Each device manufacturer or importer shall submit a written report to FDA of any correction or removal of a device initiated by such manufacturer or importer if the correction or removal was initiated:

(1) To reduce a risk to health posed by the device; or

(2) To remedy a violation of the act caused by the device which may present a risk to health unless the information has already been provided as set forth in paragraph (f) of this section or the corrective or removal action is exempt from the reporting requirements under $806.1(b).

(b) The manufacturer or importer shall submit any report required by paragraph (a) of this section within 10working days of initiating such correction or removal.

(c) The manufacturer or importer shall include the following information in the report:

(1) The seven digit registration number of the entity responsible for submission of the report of corrective or removal action (if applicable), the month, day, and year that the report is made, and a sequence number (i.e., 001 for the first report, 002 for the second report, 003 etc.), and the report type designation “C” or “R”. For example, the complete number for the first correction report submitted on June 1, 1997, will appear as follows for a firm with the registration number 1234567: 1234567-6/1/97-001-C. The second correction report number submitted by the same firm on July 1, 1997, would be 12345677/1/97-002-C etc. For removals, the number will appear as follows: 1234567-6/1/97-001-R and 12345677/1/97002-R, etc. Firms that do not have a seven digit registration number may use seven zeros followed by the month, date, year, and sequence number (i.e. 0000000-6/1/97-001-C for corrections and 0000000-7/1/97-001-R for removals). Reports received without a seven digit registration number will be assigned a seven digit central file number by the district office reviewing the reports.

(2) The name, address, and telephone (13) If any required information is number of the manufacturer or im- not immediately available, a stateporter, and the name, title, address, ment as to why it is not available and and telephone number of the manufac- when it will be submitted. turer or importer representative re (d) If, after submitting a report under sponsible for conducting the device this part, a manufacturer or importer correction or removal.

determines that the same correction or (3) The brand name and the common

removal should be extended to addiname, classification name, or usual

tional lots or batches of the same dename of the device and the intended

vice, the manufacturer or importer use of the device.

shall within 10-working days of initi(4) Marketing status of the device,

ating the extension of the correction or i.e., any applicable premarket notifica

removal, amend the report by submittion number, premarket approval num

ting an amendment citing the original ber, or indication that the device is a

report number assigned according to

paragraph (c)(1) of this section, all of preamendments device, and the device

the information required by paragraph listing number. A manufacturer or im

(c)(2), and any information required by porter that does not have an FDA establishment registration number shall

paragraphs (c)(3) through (c)(12) of this

section that is different from the inforindicate in the report whether it has

mation submitted in the original reever registered with FDA.

port. The manufacturer or importer (5) The model, catalog, or code num

shall also provide a statement in acber of the device and the manufac

cordance with paragraph (c)(13) of this turing lot or serial number of the de

section for any required information vice or other identification number.

that is not readily available. (6) The manufacturer's name, ad

(e) A report submitted by a manufacdress, telephone number, and contact

turer or importer under this section person if different from that of the per

(and any release by FDA of that report son submitting the report.

or information) does not necessarily re(7) A description of the event(s) giv flect a conclusion by the manufacturer, ing rise to the information reported

importer, or FDA that the report or inand the corrective or removal actions

formation constitutes an admission that have been, and are expected to be

that the device caused or contributed taken.

to a death or serious injury. A manu(8) Any illness or injuries that have facturer or importer need not admit, occurred with use of the device. If ap and may deny, that the report or inforplicable, include the medical device re- mation submitted under this section port numbers.

constitutes an admission that the de(9) The total number of devices man vice caused or contributed to a death ufactured or distributed subject to the or serious injury. correction or removal and the number (f) No report of a correction or rein the same batch, lot, or equivalent moval is required under this part, if a unit of production subject to the cor report of the correction or removal is rection or removal.

required and has been submitted under (10) The date of manufacture or dis parts 803, 804, or 1004 of this chapter. tribution and the device's expiration

(62 FR 27191, May 19, 1997, as amended at 63 date or expected life.

FR 42232, Aug. 7, 1998] (11) The names, addresses, and telephone numbers of all domestic and for- $ 806.20 Records of corrections and reeign consignees of the device and the movals not required to be reported. dates and number of devices distrib (a) Each device manufacturer or imuted to each such consignee.

porter who initiates a correction or re(12) A copy of all communications re- moval of a device that is not required garding the correction or removal and to be reported to FDA under 8 806.10 the names and addresses of all recipi- shall keep a record of such correction ents of the communications not pro- or removal. vided in accordance with paragraph (b) Records of corrections and remov(c)(11) of this section.

als not required to be reported to FDA

(1) Any information that constitutes trade secret or confidential commercial or financial information under $20.61 of this chapter; and

(2) Any personnel, medical, or similar information, including the serial numbers of implanted devices, which would constitute a clearly unwarranted invasion of personal privacy under $20.63 of this chapter or 5 U.S.C. 552(b)(6); provided, that except for the information under $20.61 of this chapter or 5 U.S.C. 552(b)(4), FDA will disclose to a patient who requests a report all the information in the report concerning that patient.

under $806.10 shall contain the following information:

(1) The brand name, common or usual name, classification, name and product code if known, and the intended use of the device.

(2) The model, catalog, or code number of the device and the manufacturing lot or serial number of the device or other identification number.

(3) A description of the event(s) giving rise to the information reported and the corrective or removal action that has been, and is expected to be taken.

(4) Justification for not reporting the correction or removal action to FDA, which shall contain conclusions and any followups, and be reviewed and evaluated by a designated person.

(5) A copy of all communications regarding the correction or removal.

(c) The manufacturer or importer shall retain records required under this section for a period of 2 years beyond the expected life of the device, even if the manufacturer or importer has ceased to manufacture or import the device. Records required to be maintained under paragraph (b) of this section must be transferred to the new manufacturer or importer of the device and maintained for the required period of time. [62 FR 27191, May 19, 1997, as amended at 63 FR 42233, Aug. 7, 1998]

PART 807-ESTABLISHMENT REG

ISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES

Subpart A-General Provisions

Sec. 807.3 Definitions.

Subpart B-Procedures for Domestic

Device Establishments

$ 806.30 FDA access to records.

Each device manufacturer or importer required under this part to maintain records and every person who is in charge or custody of such records shall, upon request of an officer or employee designated by FDA and under section 704(e) of the act, permit such officer or employee at all reasonable times to have access to, and to copy and verify, such records and reports. [63 FR 42233, Aug. 7, 1998] 8 806.40 Public availability of reports.

(a) Any report submitted under this part is available for public disclosure in accordance with part 20 of this chapter.

(b) Before public disclosure of a report, FDA will delete from the report:

807.20 Who must register and submit a de

vice list. 807.21 Times for establishment registration

and device listing. 807.22 How and where to register establish

ments and list devices. 807.25 Information required or requested for

establishment registration and device

listing. 807.26 Amendments to establishment reg

istration. 807.30 Updating device listing information. 807.31 Additional listing information. 807.35 Notification of registrant. 807.37 Inspection of establishment registra

tion and device listings. 807.39 Misbranding by reference to estab

lishment registration or to registration number.

Subpart C-Registration Procedures for

Foreign Device Establishments

807.40 Establishment registration and de

vice listing for U.S. agents of foreign manufacturers of devices.

Subpart D-Exemptions 807.65 Exemptions for device establish

ments.

Subpart E-Premarket Notification

Procedures 807.81 When a premarket notification sub

mission is required. 807.85 Exemption from premarket notifica

tion. 807.87 Information required in a premarket

notification submission. 807.90 Format of a premarket notification

submission. 807.92 Content and format of a 510(k) sum

mary. 807.93 Content and format of a 510(k) state

ment. 807.94 Format of class III certification. 807.95 Confidentiality of information. 807.97 Misbranding by reference to pre

market notification. 807.100 FDA action on a premarket notifica

tion. AUTHORITY: 21 U.S.C. 331, 351, 352, 360, 3600, 360e, 3600, 3600, 371, 374.

EFFECTIVE DATE NOTE: At 66 FR 5466, Jan. 19, 2001, the authority citation for part 807 was revised, effective Apr. 4, 2001. For the convenience of the user, the revised text is set forth as follows:

AUTHORITY: 21 U.S.C. 331, 351, 352, 360, 360c, 360e, 3600, 360j, 371, 374; 42 U.S.C. 264, 271.

SOURCE: 42 FR 42526, Aug. 23, 1977, unless otherwise noted.

tional use, and under section 501(f)(2)(A) of the act the device is not required to have an approved premarket approval application as provided in section 515 of the act.

(c) Establishment means a place of business under one management at one general physical location at which a device is manufactured, assembled, or otherwise processed.

(d) Manufacture, preparation, propagation, compounding, assembly, or processing of a device means the making by chemical, physical, biological, or other procedures of any article that meets the definition of device in section 201(h) of the act. These terms include the following activities:

(1) Repackaging or otherwise changing the container, wrapper, or labeling of any device package in furtherance of the distribution of the device from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer;

(2) Initial importation of devices manufactured in foreign establishments; or

(3) Initiation of specifications for devices that are manufactured by a second party for subsequent commercial distribution by the person initiating specifications.

(e) Official correspondent means the person designated by the owner or operator of an establishment as responsible for the following:

(1) The annual registration of the establishment;

(2) Contact with the Food and Drug Administration for device listing;

(3) Maintenance and submission of a current list of officers and directors to the Food and Drug Administration upon the request of the Commissioner;

(4) The receipt of pertinent correspondence from the Food and Drug Administration directed to and involving the owner or operator and/or any of the firm's establishments; and

(5) The annual certification of medical device reports required by $ 804.30 of this chapter or forwarding the certification form to the person designated by the firm as responsible for the certification.

Subpart A-General Provisions $807.3 Definitions.

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

(b) Commercial distribution means any distribution of a device intended for human use which is held or offered for sale but does not include the following:

(1) Internal or interplant transfer of a device between establishments within the same parent, subsidiary, and/or affiliate company;

(2) Any distribution of a device in tended for human use which has in effect an approved exemption for investigational use pursuant to section 520(g) of the act and part 812 of this chapter; or

(3) Any distribution of a device, before the effective date of part 812 of this chapter, that was not introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, and that is classified into class III under section 513(f) of the act: Provided, That the device is intended solely for investiga

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