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

(1) Report to FDA in accordance with $$ 803.50, 803.52, 803.53, 803.55, and 803.56;

(2) Conduct, or obtain from the foreign manufacturer the necessary information regarding, the investigation and evaluation of the event to comport with the requirements of 8 803.50;

(3) Certify in accordance with $ 803.57;

(4) Forward MDR complaints to the foreign manufacturer and maintain documentation of this requirement;

(5) Maintain complaint files in accordance with $ 803.18; and

(6) Register, list, and submit premarket notifications in accordance with part 807 of this chapter.

EFFECTIVE DATE NOTE: At 61 FR 38347, July 23, 1996, § 803.58 was stayed indefinitely.

(b) The following actions are exempt from the reporting requirements of this part:

(1) Actions taken by device manufacturers or importers to improve the performance or quality of a device but that do not reduce a risk to health posed by the device or remedy a violation of the act caused by the device.

(2) Market withdrawals as defined in $ 806.2(h).

(3) Routine servicing as defined in $ 806.2(k).

(4) Stock recoveries as defined in $ 806.2(1). [62 FR 27191, May 19, 1997, as amended at 63 FR 42232, Aug. 7, 1998]

PART 806-MEDICAL DEVICES; RE

PORTS OF CORRECTIONS AND REMOVALS

Subpart A-General Provisions

Sec. 806.1 Scope. 806.2 Definitions.

Subpart B-Reports and Records 806.10 Reports of corrections and removals. 806.20 Records of corrections and removals

not required to be reported. 806.30 FDA access to records. 806.40 Public availability of reports.

AUTHORITY: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.

8806.2 Definitions.

As used in this part:

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

(b) Agency or FDA means the Food and Drug Administration.

(c) Consignee means any person or firm that has received, purchased, or used a device subject to correction or removal.

(d) Correction means the repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a device without its physical removal from its point of use to some other location.

(e) Correction or removal report number means the number that uniquely identifies each report submitted.

(f) Importer means, for the purposes of this part, any person who imports a device into the United States.

(g) Manufacturer means any person who manufactures, prepares, propagates, compounds, assembles, or processes a device by chemical, physical, biological, or other procedures. The term includes any person who:

(1) Repackages or otherwise changes the container, wrapper, or labeling of a device 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 user or consumer;

(2) Initiates specifications for devices that are manufactured by a second party for subsequent distribution by the person initiating the specifications; or

SOURCE: 62 FR 27191, May 19, 1997, unless otherwise noted.

Subpart A-General Provisions $ 806.1 Scope.

(a) This part implements the provisions of section 519(f) of the Federal Food, Drug, and Cosmetic Act (the act) requiring device manufacturers and importers to report promptly to the Food and Drug Administration (FDA) certain actions concerning device corrections and removals, and to maintain records of all corrections and removals regardless of whether such corrections and removals are required to be reported to FDA.

194-069 D-01--3

(3) Manufactures components or ac- Subpart B-Reports and Records cessories which are devices that are ready to be used and are intended to be 8 806.10 Reports of corrections and recommercially distributed and are in- movals. tended to be used as is, or are processed (a) Each device manufacturer or imby a licensed practitioner or other

porter shall submit a written report to qualified person to meet the needs of a FDA of any correction or removal of a particular patient.

device initiated by such manufacturer (h) Market withdrawal means a cor- or importer if the correction or rerection or removal of a distributed de- moval was initiated: vice that involves a minor violation of (1) To reduce a risk to health posed the act that would not be subject to by the device; or legal action by FDA or that involves

(2) To remedy a violation of the act no violation of the act, e.g., normal caused by the device which may stock rotation practices.

present a risk to health unless the in(1) Removal means the physical re- formation has already been provided as moval of a device from its point of use set forth in paragraph (f) of this secto some other location for repair, tion or the corrective or removal acmodification, adjustment, relabeling, tion is exempt from the reporting redestruction, or inspection.

quirements under $806.1(b). (j) Risk to health means

(b) The manufacturer or importer (1) A reasonable probability that use shall submit any report required by of, or exposure to, the product will paragraph (a) of this section within 10cause serious adverse health con- working days of initiating such correcsequences or death; or

tion or removal. (2) That use of, or exposure to, the (c) The manufacturer or importer product may cause temporary or medi- shall include the following information cally reversible adverse health con

in the report: sequences, or an outcome where the (1) The seven digit registration numprobability of serious adverse health ber of the entity responsible for subconsequences is remote.

mission of the report of corrective or (k) Routine servicing means any regu

removal action (if applicable), the larly scheduled maintenance of a de- month, day, and year that the report is vice, including the replacement of

made, and a sequence number (i.e., 001 parts at the end of their normal life ex- for the first report, 002 for the second pectancy, e.g., calibration, replace

report, 003 etc.), and the report type ment of batteries, and responses to

designation “C” or “R”. For example, normal wear and tear. Repairs of an

the complete number for the first corunexpected nature, replacement of

rection report submitted on June 1, parts earlier than their normal life ex

1997, will appear as follows for a firm pectancy, or identical repairs or re

with the registration number 1234567:

1234567-6/1/97-001-C. The second correcplacements of multiple units of a device are not routine servicing.

tion report number submitted by the

same firm on July 1, 1997, would be (1) Stock recovery means the correction or removal of a device that has

1234567–7/1/97-002-C etc. For removals, not been marketed or that has not left

the number will appear as follows:

1234567–6/1/97-001-R and 1234567–7/1/97the direct control of the manufacturer,

002–R, etc. Firms that do not have a i.e., the device is located on the prem

seven digit registration number may ises owned, or under the control of, the

use seven zeros followed by the month, manufacturer, and no portion of the

date, year, and sequence number (i.e. lot, model, code, or other relevant unit

0000000-6/1/97-001-C for corrections and involved in the corrective or removal

0000000-7/1/97-001-R for removals). Reaction has been released for sale or use.

ports received without a seven digit (62 FR 27191, May 19, 1997, as amended at 63 registration number will be assigned a FR 42232, Aug. 7, 1998]

seven digit central file number by the district office reviewing the reports.

(2) The name, address, and telephone number of the manufacturer or importer, and the name, title, address, and telephone number of the manufacturer or importer representative responsible for conducting the device correction or removal.

(3) The brand name and the common name, classification name, or usual name of the device and the intended use of the device.

(4) Marketing status of the device, i.e., any applicable premarket notification number, premarket approval number, or indication that the device is a preamendments device, and the device listing number. A manufacturer or importer that does not have an FDA establishment registration number shall indicate in the report whether it has ever registered with FDA.

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

(6) The manufacturer's name, address, telephone number, and contact person if different from that of the person submitting the report.

(7) A description of the event(s) giving rise to the information reported and the corrective or removal actions that have been, and are expected to be taken.

(8) Any illness or injuries that have occurred with use of the device. If applicable, include the medical device report numbers.

(9) The total number of devices manufactured or distributed subject to the correction or removal and the number in the same batch, lot, or equivalent unit of production subject to the correction or removal.

(10) The date of manufacture or distribution and the device's expiration date or expected life.

(11) The names, addresses, and telephone numbers of all domestic and foreign consignees of the device and the dates and number of devices distributed to each such consignee.

(12) A copy of all communications regarding the correction or removal and the names and addresses of all recipients of the communications not provided in accordance with paragraph (c)(11) of this section.

(13) If any required information is not immediately available, a statement as to why it is not available and when it will be submitted.

(d) If, after submitting a report under this part, a manufacturer or importer determines that the same correction or removal should be extended to additional lots or batches of the same device, the manufacturer or importer shall within 10-working days of initiating the extension of the correction or removal, amend the report by submitting an amendment citing the original report number assigned according to paragraph (c)(1) of this section, all of the information required by paragraph (c)(2), and any information required by paragraphs (c)(3) through (c)(12) of this section that is different from the information submitted in the original report. The manufacturer or importer shall also provide a statement in accordance with paragraph (C)(13) of this section for any required information that is not readily available.

(e) A report submitted by a manufacturer or importer under this section (and any release by FDA of that report or information) does not necessarily reflect a conclusion by the manufacturer, importer, or FDA that the report or information constitutes an admission that the device caused or contributed to a death or serious injury. A manufacturer or importer need not admit, and may deny, that the report or information submitted under this section constitutes an admission that the device caused or contributed to a death or serious injury.

(f) No report of a correction or removal is required under this part, if a report of the correction or removal is required and has been submitted under parts 803, 804, or 1004 of this chapter. (62 FR 27191, May 19, 1997, as amended at 63 FR 42232, Aug. 7, 1998]

$ 806.20 Records of corrections and re

movals not required to be reported. (a) Each device manufacturer or importer who initiates a correction or removal of a device that is not required to be reported to FDA under $806.10 shall keep a record of such correction or removal.

(b) Records of corrections and removals 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.

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

[62 FR 27191, May 19, 1997, as amended at 63 FR 42233, Aug. 7, 1998]

8 806.30 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]

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.

$ 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:

Subpart D-Exemptions

device

establish

807.65 Exemptions for

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

premarket notification. 807.100 FDA action on a premarket notifica

tion. AUTHORITY: 21 U.S.C. 331, 351, 352, 360, 360c, 360e, 360i, 360j, 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, 360i, 3600, 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 involying 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

8807.3 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 intended 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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