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(6) Updating is not required if the joint ownership and control exists, the above information has not changed registered establishment must provide since the previously submitted list. the Food and Drug Administration Also, updating is not required if with a letter authorizing the establishchanges occur in proprietary names, in ment outside its control to maintain common or usual names (blocks 10 and

the historical file. 11 of form FD-2892), or to supplemental

(3) A copy of the certification and lists of unclassified components or ac

disclosure statements as required by cessories.

part 54 of this chapter shall be retained (43 FR 37998, Aug. 25, 1978)

and physically located at the establish

ment maintaining the historical file. $807.31 Additional listing information.

(e) Each owner or operator shall be (a) Each owner or operator shall prepared to submit to the Food and maintain a historical file containing Drug Administration, only upon spethe labeling and advertisements in use

cific request, the following informaon the date of initial listing, and in use

tion: after October 10, 1978, but before the date of initial listing, as follows:

(1) For a device subject to section 514

or 515 of the act that is not a restricted (1) For each device subject to section 514 or 515 of the act that is not a re

device, a copy of all labeling for the destricted device, a copy of all labeling

vice. for the device;

(2) For a device that is a restricted (2) For each restricted device, a copy

device, a copy of all labeling for the deof all labeling and advertisements for vice, a representative sampling of adthe device;

vertisements for the device, and for (3) For each device that is neither re- good cause, a copy of all advertisestricted nor subject to section 514 or ments for a particular device. A re515 of the act, a copy of all labels, quest for all advertisements will, where package inserts, and a representative feasible, be accompanied by an explasampling of any other labeling.

nation of the basis for such request. (b) In addition to the requirements

(3) For a device that is neither a reset forth in paragraph (a) of this sec

stricted device, nor subject to section tion, each owner or operator shall maintain in the historical file any la

514 of 515 of the act, the label and packbeling or advertisements in which a

age insert for the device and a repmaterial change has been made any

resentative sampling of any other latime after initial listing.

beling for the device. (c) Each owner or operator may dis

(4) For a particular device, a statecard labeling and advertisements from

ment of the basis upon which the regthe historical file 3 years after the date istrant has determined that the device of the last shipment of a discontinued is not subject to section 514 or 515 of device by an owner or operator.

the act. (d) Location of the file:

(5) For a particular device, a state(1) Currently existing systems for ment of the basis upon which the regmaintenance of labeling and adver- istrant has determined the device is tising may be used for the purpose of not a restricted device. maintaining the historical file as long

(6) For a particular device, a stateas the information included in the sys

ment of the basis for determining that tems fulfills the requirements of this

the product is a device rather than a section, but only if the labeling and ad

drug. vertisements are retrievable in a time

(7) For a device that the owner or oply manner.

erator has manufactured for distribu(2) The contents of the historical file

tion under a label other than its own, may be physically located in more than one place in the establishment or in

the names of all distributors for whom more than one establishment provided

it has been manufactured. there exists joint ownership and con- (43 FR 37999, Aug. 25, 1978, as amended at 51 trol among all the establishments FR 33033, Sept. 18, 1986; 63 FR 5253, Feb. 2, maintaining the historical file. If no 1998]

8807.35 Notification of registrant. location of a registered establishment (a) The Commissioner will provide to

will be provided. the official correspondent, at the ad

(b)(1) The following information filed dress listed on the form, a validated

under the device listing requirements copy of Form FD-2891 or Form FD

will be available for public disclosure: 2891(a) (whichever is applicable) as evi

(i) Each form FD-2892 submitted; dence of registration. A permanent reg

(ii) All labels submitted; istration number will be assigned to

(iii) All labeling submitted; each device establishment registered in

(iv) All advertisements submitted; accordance with these regulations.

(v) All data or information that has (b) Owners and operators of device es- already become a matter of public tablishments who also manufacture or knowledge. process blood or drug products at the (2) Requests for device listing inforsame establishment shall also register mation identified in paragraph (b)(1) of with the Center for Biologics Evalua- this section should be directed to the tion and Research and Center for Drug Center for Devices and Radiological Evaluation and Research, as appro- Health (HFZ-342), Food and Drug Adpriate. Blood products shall be listed ministration, Department of Health with the Center for Biologics Evalua- and Human Services, 1390 Piccard Dr., tion and Research, Food and Drug Ad- Rockville, MD 20850. ministration, pursuant to part 607 of (3) Requests for device listing inforthis chapter; drug products shall be mation not identified in paragraph listed with the Center for Drug Evalua- (b)(1) of this section shall be submitted tion and Research, Food and Drug Ad- and handled in accordance with part 20 ministration, pursuant to part 207 of of this chapter. this chapter. (c) Although establishment registra

[43 FR 37999, Aug. 25, 1978, as amended at 53 tion and device listing are required to

FR 11252, Apr. 6, 1988; 55 FR 11169, Mar. 27,

1990] engage in the device activities described in 8807.20, validation of reg

8 807.39 Misbranding by reference to istration and the assignment of a de- establishment registration or to vice listing number in itself does not registration number. establish that the holder of the reg

Registration of a device establishistration is legally qualified to deal in such devices and does not represent a

ment or assignment of a registration

number does not in any way denote apdetermination by the Food and Drug

proval of the establishment or its prodAdministration as to the status of any device.

ucts. Any representation that creates

an impression of official approval be[42 FR 42526, Aug. 23, 1977, as amended at 43 cause of registration or possession of a FR 37999, Aug. 25, 1978; 53 FR 11252, Apr. 6, registration number is misleading and 1988]

constitutes misbranding. $ 807.37 Inspection of establishment

registration and device listings. Subpart C-Registration Proce(a) A copy of the forms FD-2891 and dures for Foreign Device EsFD-2891a filed by the registrant will be

tablishments available for inspection in accordance with section 510(f) of the act, at the

8 807.40 Establishment registration Center for Devices and Radiological

and device listing for U.S.

agents of Health (HFZ-342), Food and Drug Ad

foreign manufacturers of devices. ministration, Department of Health

(a) Each foreign device manufacturer and Human Services, 1390 Piccard Dr., who exports devices into the United Rockville, MD 20850. In addition, there States shall designate a person as their will be available for inspection at each U.S.-designated agent, who is responof the Food and Drug Administration sible for: district offices the same information (1) Submitting MDR reports, for firms within the geographical area (2) Submitting annual certifications, of such district office. Upon request, (3) Acting the official verification of registration number or respondent,

as

cor

(4) Submitting registration information,

(5) Submitting device listing information, and

(6) Submitting premarket notifications.

(b) The foreign manufacturer shall provide FDA with a statement of authorization for their U.S.-designate to perform MDR reporting duties under part 803 of this chapter, and to register, list, and submit premarket notifications under this part. The foreign manufacturer must provide this statement of authorization along with the name, address, and telephone number of the person initially designated, or any subsequent person designated as the U.S.designated agent, within 5 days of the initial or subsequent designation. Information shall be sent to the Center for Devices and Radiological Health, Medical Device Reporting, Food and Drug Administration, P.O. Box 3002, Rockville, MD 20847–3002.

(c) The U.S.-designated agent of a foreign device manufacturer that exports devices into the United States is required to register the foreign manufacturer's establishments or places of business, and to list the foreign manufacturer's devices, in accordance with subpart B of this part, unless exempt under subpart D of this part, and to submit premarket notifications in accordance with subpart E of this part. The information submitted shall be in the English language. [60 FR 63606, Dec. 11, 1995)

EFFECTIVE DATE NOTE: At 61 FR 38347, July 23, 1996, 8807.40 was stayed indefinitely.

would otherwise not be required to register under the provisions of this part.

(b) A manufacturer of devices to be used solely for veterinary purposes.

(c) A manufacturer of general purpose articles such as chemical reagents or laboratory equipment whose uses are generally known by persons trained in their use and which are not labeled or promoted for medical uses.

(d) Licensed practitioners, including physicians, dentists, and optometrists, who manufacture or otherwise alter devices solely for use in their practice.

(e) Pharmacies, surgical supply outlets, or other similar retail establishments making final delivery or sale to the ultimate user. This exemption also applies to a pharmacy or other similar retail establishment that purchases a device for subsequent distribution under its own name, e.g., a properly labeled health aid such as an elastic bandage or crutch, indicating "distributed by" or "manufactured for" followed by the name of the pharmacy.

(f) Persons who manufacture, prepare, propagate, compound, or process devices solely for use in research, teaching, or analysis and do not introduce such devices into commercial distribution.

(g) [Reserved)

(h) Carriers by reason of their receipt, carriage, holding or delivery of devices in the usual course of business as carriers.

(i) Persons who dispense devices to the ultimate consumer or whose major responsibility is to render a service necessary to provide the consumer (i.e., patient, physician, layman, etc.) with a device or the benefits to be derived from the use of a device; for example, a hearing aid dispenser, optician, clinical laboratory, assembler of diagnostic xray systems, and personnel from a hospital, clinic, dental laboratory, orthotic or prosthetic retail facility, whose primary responsibility to the ultimate consumer is to dispense or provide a service through the use of a previously manufactured device. (42 FR 42526, Aug. 23, 1977, as amended at 58 FR 46523, Sept. 1, 1993; 61 FR 44615, Aug. 28, 1996; 65 FR 17136, Mar. 31, 2000)

Subpart D-Exemptions 8 807.65 Exemptions for device estab

lishments. The following classes of persons are exempt from registration in accordance with $807.20 under the provisions of section 510(g) (1), (2), and (3) of the act, or because the Commissioner has found, under section 510(g)(4) of the act, that such registration is not necessary for the protection of the public health:

(a) A manufacturer of raw materials or components to be used in the manufacture or assembly of a device who

Subpart E-Premarket Notification

Procedures

$ 807.81 When a premarket notification

submission is required. (a) Except as provided in paragraph (b) of this section, each person who is required to register his establishment pursuant to $807.20 must submit a premarket notification submission to the Food and Drug Administration at least 90 days before he proposes to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a device intended for human use which meets any of the following criteria:

(1) The device is being introduced into commercial distribution for the first time; that is, the device is not of the same type as, or is not substantially equivalent to, (i) a device in commercial distribution before May 28, 1976, or (ii) a device introduced for commercial distribution after May 28, 1976, that has subsequently been reclassified into class I or II.

(2) The device is being introduced into commercial distribution for the first time by a person required to register, whether or not the device meets the criteria in paragraph (a)(1) of this section.

(3) The device is one that the person currently has in commercial distribution or is reintroducing into commercial distribution, but that is about to be significantly changed or modified in design, components, method of manufacture, or intended use. The following constitute significant changes or modifications that require a premarket notification:

(i) A change or modification in the device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process.

(ii) A major change or modification in the intended use of the device.

(b) A premarket notification under this subpart is not required for a device for which a premarket approval application under section 515 of the act, or for which a petition to reclassify under section 513(f)(2) of the act, is pending

before the Food and Drug Administration.

(c) In addition to complying with the requirements of this part, owners or operators of device establishments that manufacture radiation-emitting electronic products, as defined in $1000.3 of this chapter, shall comply with the reporting requirements of part 1002 of this chapter. 8 807.85 Exemption from premarket

notification. (a) A device is exempt from the premarket notification requirements of this subpart if the device intended for introduction into commercial distribution is not generally available in finished form for purchase and is not offered through labeling or advertising by the manufacturer, importer, or distributor thereof for commercial distribution, and the device meets one of the following conditions:

(1) It is intended for use by a patient named in the order of the physician or dentist (or other specially qualified person); or

(2) It is intended solely for use by a physician or dentist (or other specially qualified person) and is not generally available to, or generally used by, other physicians or dentists (or other specially qualified persons).

(b) A distributor who places a device into commercial distribution for the first time under his own name and a repackager who places his own name on a device and does not change any other labeling or otherwise affect the device shall be exempted from the premarket notification requirements of this subpart if:

(1) The device was in commercial distribution before May 28, 1976; or

(2) A premarket notification submission was filed by another person. 8 807.87 Information required in a pre

market notification submission. Each premarket notification submission shall contain the following information:

(a) The device name, including both the trade or proprietary name and the common or usual name or classification name of the device.

(b) The establishment registration number, if applicable, of the owner or

operator submitting the premarket notification submission.

(c) The class in which the device has been put under section 513 of the act and, if known, its appropriate panel; or, if the owner or operator determines that the device has not been classified under such section, a statement of that determination and the basis for the person's determination that the device is not so classified.

(d) Action taken by the person required to register to comply with the requirements of the act under section 514 for performance standards.

(e) Proposed labels, labeling, and advertisements sufficient to describe the device, its intended use, and the directions for its use. Where applicable, photographs or engineering drawings should be supplied.

(f) A statement indicating the device is similar to and/or different from other products of comparable type in commercial distribution, accompanied by data to support the statement. This information may include an identification of similar products, materials, design considerations, energy expected to be used or delivered by the device, and a description of the operational principles of the device.

(g) Where a person required to register intends to introduce into commercial distribution a device that has undergone a significant change modification that could significantly affect the safety or effectiveness of the device, or the device is to be marketed for a new or different indication for use, the premarket notification submission must include appropriate supporting data to show that the manufacturer has considered what sequences and effects the change or modification or new use might have on the safety and effectiveness of the device.

(h) A 510(k) summary as described in $ 807.92 or a 510(k) statement as described in $ 807.93.

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

(j) For submissions claiming substantial equivalence to a device which has been classified into class III under section 513(b) of the act:

(1) Which was introduced or delivered for introduction into interstate commerce for commercial distribution before December 1, 1990; and

(2) For which no final regulation requiring premarket approval has been issued under section 515(b) of the act, a summary of the types of safety and effectiveness problems associated with the type of devices being compared and a citation to the information upon which the summary is based (class III summary). The 510(k) submitter shall also certify that a reasonable search of all information known or otherwise available about the class III device and other similar legally marketed devices has been conducted (class III certification), as described in $ 807.94. This information does not refer to information that already has been submitted to the Food and Drug Administration (FDA) under section 519 of the act. FDA may require the submission of the adverse safety and effectiveness data described in the class III summary or citation.

(k) A statement that the submitter believes, to the best of his or her knowledge, that all data and information submitted in the premarket notification are truthful and accurate and that no material fact has been omitted.

(1) Any additional information regarding the device requested by the Commissioner that is necessary for the Commissioner to make a finding as to whether or not the device is substantially equivalent to a device in commercial distribution. A request for additional information will advise the owner or operator that there is insufficient information contained in the original premarket notification submission for the Commissioner to make this determination and that the owner or operator may either submit the requested data or a new premarket notification containing the requested information at least 90 days before the owner or operator intends to market the device, or submit a premarket approval application in accordance with section 515 of the act. If the additional information is not submitted within 30 days following the date of the request, the Commissioner will consider the

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