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premarket notification to be withdrawn. (Information collection requirements in this section were approved by the Office of Management and Budget (OMB) and assigned OMB control number 0910-0281) (42 FR 42526, Aug 23, 1977, as amended at 57 FR 18066, Apr. 28, 1992; 59 FR 64295, Dec. 14, 1994; 63 FR 5253, Feb. 2, 1998]
$ 807.90 Format of a premarket notifi.
cation submission. Each premarket notification submission pursuant to this part shall be submitted in accordance with this section. Each submission shall:
(a)(1) For devices regulated by the Center for Devices and Radiological Health, be addressed to the Food and Drug Administration, Center for Devices and Radiological Health (HFZ401), 9200 Corporate Blvd., Rockville, MD 20850.
(2) For devices regulated by the Center for Biologics Evaluation and Research, be addressed to the Food and Drug Administration, Center for Biologics Evaluation and Research, Document Control Room (HFM-99), 1401 Rockville Pike, Rockville, MD 20852 1448. Information about devices regulated by the Center for Biologics Evaluation and Research is available at http://www.fda.gov/cber/dap/devlst.htm on the Internet.
(3) All inquiries regarding a premarket notification submission should be in writing and sent to one of the addresses above.
(b) Be bound into a volume or volumes, where necessary.
(c) Be submitted in duplicate on standard size paper, including the original and two copies of the cover letter.
(d) Be submitted separately for each product the manufacturer intends to market.
(e) Designated “510(k) Notification” in the cover letter. [42 FR 42526, Aug. 23, 1977, as amended at-53 FR 11252, Apr. 6, 1988; 55 FR 11169, Mar. 27, 1990; 65 FR 17137, Mar. 31, 2000]
tion of substantial equivalence. FDA will accept summaries as well as amendments thereto until such time as FDA issues a determination of substantial equivalence. All 510(k) summaries shall contain the following information:
(1) The submitter's name, address, telephone number, a contact person, and the date the summary was prepared;
(2) The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known;
(3) An identification of the legally marketed device to which the submitter claims equivalence. A legally marketed device to which a new device may be compared for a determination regarding substantial equivalence is a device that was legally marketed prior to May 28, 1976, or a device which has been reclassified from class III to class II or I (the predicate), or a device which has been found to be substantially equivalent through the 510(k) premarket notification process;
(4) A description of the device that is the subject of the premarket notification submission, such as might be found in the labeling or promotional material for the device, including an explanation of how the device functions, the scientific concepts that form the basis for the device, and the significant physical and performance characteristics of the device, such as device design, material used, and physical properties;
(5) A statement of the intended use of the device that is the subject of the premarket notification submission, including a general description of the diseases or conditions that the device will diagnose, treat, prevent, cure, or mitigate, including description. where appropriate, of the patient population for which the device is intended. If the indication statements are different from those of the legally marketed device identified in paragraph (a)(3) of this section, the 510(k) summary shall contain an explanation as to why the differences are not critical to the intended therapeutic, diagnostic, prosthetic, or surgical use of the device, and why the differences do
$ 807.92 Content and format of a 510(k)
summary. (a) A 510(k) summary shall be in sufficient detail to provide an understanding of the basis for a determina
(d) Any other information reasonably deemed necessary by the agency. (57 FR 18066, Apr. 28, 1992, as amended at 59 FR 64295, Dec. 14, 1994)
not affect the safety and effectiveness of the device when used as labeled; and
(6) If the device has the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate device identified in paragraph (a)(3) of this section, a summary of the technological characteristics of the new device in comparison to those of the predicate device. If the device has different technological characteristics from the predicate device, a summary of how the technological characteristics of the device compare to a legally marketed device identified in paragraph (a)(3) of this section.
(b) 510(k) summaries for those premarket submissions in which a determination of substantial equivalence is also based on an assessment of performance data shall contain the following information:
(1) A brief discussion of the nonclinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence;
(2) A brief discussion of the clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence. This discussion shall include, where applicable, a description of the subjects upon whom the device was tested, a discussion of the safety or effectiveness data obtained from the testing, with specific reference to adverse effects and complications, and any other information from the clinical testing relevant to a determination of substantial equivalence; and
(3) The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device identified in paragraph (a)(3) of this section.
(C) The summary should be in a separate section of the submission, beginning on a new page and ending on a page not shared with any other section of the premarket notification submission, and should be clearly identified as a “510(k) summary."
$ 807.93 Content and format of a 510(k)
statement. (a)(1) A 510(k) statement submitted as part of a premarket notification shall state as follows:
I certify that, in my capacity as (the position held in company by person required to submit the premarket notification, preferably the official correspondent in the firm), of (company name), I will make available all information included in this premarket notification on safety and effectiveness within 30 days of request by any person if the device described in the premarket notification submission is determined to be substantially equivalent. The information I agree to make available will be a duplicate of the premarket notification submission, including any adverse safety and effectiveness information, but excluding all patient identifiers, and trade secret and confidential commercial information, as defined in 21 CFR 20.61.
(2) The statement in paragraph (a)(1) of this section should be signed by the certifier, made on a separate page of the premarket notification submission, and clearly identified as “510(k) statement.”
(b) All requests for information included in paragraph (a) of this section shall be made in writing to the certifier, whose name will be published by FDA on the list of premarket notification submissions for which substantial equivalence determinations have been made.
(c) The information provided to requestors will be a duplicate of the premarket notification submission, including any adverse information, but excluding all patient identifiers, and trade secret and confidential commercial information as defined in $20.61 of this chapter. [59 FR 64295, Dec. 14, 1994)
8807.94 Format of a class III certifi.
cation. (a) A class III certification submitted as part of a premarket notification shall state as follows:
I certify, in my capacity as (position held in company), of (company name), that I have conducted a reasonable search of all information known or otherwise available about the types and causes of safety or effectiveness problems that have been reported for the (type of device). I further certify that I am aware of the types of problems to which the (type of device) is susceptible and that, to the best of my knowledge, the following summary of the types and causes of safety or effectiveness problems about the (type of device) is complete and accurate.
(b) The statement in paragraph (a) of this section should be signed by the certifier, clearly identified as "class III certification," and included at the beginning of the section of the premarket notification submission that sets forth the class III summary. (59 FR 64296, Dec. 14, 1994),
$ 807.95 Confidentiality of information.
(a) The Food and Drug Administration will disclose publicly whether there exists a premarket notification submission under this part:
(1) Where the device is on the market, i.e., introduced or delivered for introduction into interstate commerce for commercial distribution;
(2) Where the person submitting the premarket notification submission has disclosed, through advertising or any other manner, his intent to market the device to scientists, market analysts, exporters, or other individuals who are not employees of, or paid consultants to, the establishment and who are not in an advertising or law firm pursuant to commercial arrangements with appropriate safeguards for secrecy; or
(3) Where the device is not on the market and the intent to market the device has not been so disclosed, except where the submission is subject to an exception under paragraph (b) or (c) of this section.
(b) The Food and Drug Administration will not disclose publicly the existence of a premarket notification submission for a device that is not on the market and where the intent to market the device has not been disclosed for 90 days from the date of receipt of the submission, if:
(1) The person submitting the premarket notification submission requests in the submission that the Food and Drug Administration hold as confidential commercial information the
intent to market the device and submits a written certification to the Commissioner:
(i) That the person considers his intent to market the device to be confidential commercial information;
(ii) That neither the person nor, to the best of his knowledge, anyone else, has disclosed through advertising or any other manner, his intent to market the device to scientists, market analysts, exporters, or other individuals, except employees of, or paid consultants to, the establishment or individuals in an advertising or law firm pursuant to commercial arrangements with appropriate safeguards for secrecy;
(iii) That the person will immediately notify the Food and Drug Administration if he discloses the intent to market the device to anyone, except employees of, or paid consultants to, the establishment or individuals in an advertising or law firm pursuant to commercial arrangements with appropriate safeguards for secrecy;
(iv) That the person has taken precautions to protect the confidentiality of the intent to market the device; and
(v) That the person understands that the submission to the government of false information is prohibited by 18 U.S.C. 1001 and 21 U.S.C. 331(q); and
(2) The Commissioner agrees that the intent to market the device is confidential commercial information.
(c) Where the Commissioner determines that the person has complied with the procedures described in paragraph (b) of this section with respect to a device that is not on the market and where the intent to market the device has not been disclosed, and the Commissioner agrees that the intent to market the device is confidential commercial information, the Commissioner will not disclose the existence of the submission for 90 days from the date of its receipt by the agency. In addition, the Commissioner will continue not to disclose the existence of such a submission for the device for an additional time when any of the following occurs:
(1) The Commissioner requests in writing additional information regarding the device pursuant to $807.87(h), in which case the Commissioner will not
disclose the existence of the submis- $ 807.97 Misbranding by reference to sion until 90 days after the Food and premarket notification. Drug Administration's receipt of a
Submission of a premarket notificacomplete premarket notification sub
tion in accordance with this subpart, mission;
and a subsequent determination by the (2) The Commissioner determines Commissioner that the device intended that the device intended to be intro- for introduction into commercial disduced is a class III device and cannot
tribution is substantially equivalent to be marketed without premarket ap- a device in commercial distribution beproval or reclassification, in which
fore May 28, 1976, or is substantially case the Commissioner will not dis
equivalent to a device introduced into close the existence of the submission commercial distribution after May 28, unless a petition for reclassification is 1976, that has subsequently been reclassubmitted under section 513(1)(2) of the sified into class I or II, does not in any act and its existence can be disclosed way denote official approval of the deunder $860.5(d) of this chapter; or
vice. Any representation that creates (d) FDA will make a 510(k) summary an impression of official approval of a of the safety and effectiveness data device because of complying with the available to the public within 30 days premarket notification regulations is of the issuance of a determination that misleading and constitutes misthe device is substantially equivalent branding. to another device. Accordingly, even when a 510(k) submitter has complied
$ 807.100 FDA action on a premarket with the conditions set forth in para
notification. graphs (b) and (c) of this section, con- (a) After review of a premarket notifidentiality for a premarket notifica- fication, FDA will: tion submission cannot be granted be- (1) Issue an order declaring the device yond 30 days after FDA issues a deter- to be substantially equivalent to a lemination of equivalency.
gally marketed predicate device; (e) Data or information submitted (2) Issue an order declaring the device with, or incorporated by reference in, a to be not substantially equivalent to premarket notification submission any legally marketed predicate device; (other than safety and effectiveness (3) Request additional information; data that have not been disclosed to the public) shall be available for disclo- (4) Withhold the decision until a cersure by the Food and Drug Administra- tification or disclosure statement is tion when the intent to market the de- submitted to FDA under part 54 of this vice is no longer confidential in accord- chapter. ance with this section, unless exempt (5) Advise the applicant that the prefrom public disclosure in accordance market notification is not required. with part 20 of this chapter. Upon final Until the applicant receives an order classification, data and information re- declaring a device substantially equivlating to safety and effectiveness of a alent, the applicant may not proceed to device classified in class I (general con- market the device. trols) or class II (performance stand- (b) FDA will determine that a device ards) shall be available for public dis- is substantially equivalent to a prediclosure. Data and information relating cate device using the following crito safety and effectiveness of a device teria: classified in class III (premarket ap- (1) The device has the same intended proval) that have not been released to use as the predicate device; and the public shall be retained as con- (2) The device: fidential unless such data and informa
(i) Has the same technological chartion become available for release to the
acteristics as the predicate device; or public under $860.5(d) or other provi
(ii)(A) Has different technological sions of this chapter.
characteristics, such as a significant [42 FR 42526, Aug. 23, 1977, as amended at 53 change in the materials, design, energy FR 11252, Apr. 6, 1988; 57 FR 18067, Apr. 28, source, or other features of the device 1992; 59 FR 64296, Dec. 14, 1994)
from those of the predicate device;
(B) The data submitted establishes 808.101 District of Columbia. that the device is substantially equiva
AUTHORITY: 21 U.S.C. 360j, 360k, 371. lent to the predicate device and contains information, including clinical
SOURCE: 43 FR 18665, May 2, 1978, unless
otherwise noted. data if deemed necessary by the Commissioner, that demonstrates that the device is as safe and as effective as a
Subpart A-General Provisions legally marketed device; and (C) Does not raise different questions
$ 808.1 Scope. of safety and effectiveness than the (a) This part prescribes procedures predicate device.
for the submission, review, and ap(3) The predicate device has not been proval of applications for exemption removed from the market at the initia- from Federal preemption of State and tive of the Commissioner of Food and local requirements applicable to medDrugs or has not been determined to be ical devices under section 521 of the misbranded or adulterated by a judicial act. order.
(b) Section 521(a) of the act contains
special provisions governing the regu(57 FR 58403, Dec. 10, 1992, as amended at 63 FR 5253, Feb. 2, 1998]
lation of devices by States and local
ities. That section prescribes a general PART 808-EXEMPTIONS FROM
rule that after May 28, 1976, no State or
political subdivision of a State may esFEDERAL PREEMPTION OF STATE
tablish or continue in effect any reAND LOCAL MEDICAL DEVICE quirement with respect to a medical REQUIREMENTS
device intended for human use having
the force and effect of law (whether esSubpart A-General Provisions
tablished by statute, ordinance, regula
tion, or court decision), which is difSec. 808.1 Scope.
ferent from, or in addition to, any re808.3 Definitions.
quirement applicable to such device 808.5 Advisory opinions.
under any provision of the act and
which relates to the safety or effectiveSubpart B-Exemption Procedures ness of the device or to any other mat808.20 Application.
ter included in a requirement applica808.25 Procedures for processing an applica
ble to the device under the act. tion.
(c) Section 521(b) of the act contains 808.35 Revocation of an exemption.
a provision whereby the Commissioner
of Food and Drugs may, upon applicaSubpart C-Listing of Specific State and
tion by a State or political subdivision, Local Exemptions
allow imposition of a requirement 808.53 Arizona.
which is different from, or in addition 808.55 California
to, any requirement applicable under 808.57 Connecticut.
the act to the device (and which is 808.59 Florida.
thereby preempted) by promulgating a 808.61 Hawaii.
regulation in accordance with this part 808.67 Kentucky.
exempting the State or local require808.69 Maine.
ment from preemption. The granting of 808.71 Massachusetts. 808.73 Minnesota.
an exemption does not affect the appli808.74 Mississippi.
cability to the device of any require808.77 Nebraska.
ments under the act. The Commis808.80 New Jersey.
sioner may promulgate an exemption 808.81 New Mexico.
regulation for the preempted require808.82 New York.
ment if he makes either of the fol808.85 Ohio.
lowing findings: 808.87 Oregon.
(1) That the requirement is more 808.88 Pennsylvania. 808.89 Rhode Island.
stringent than a requirement under the 808.93 Texas.
act applicable to the device; or 808.97 Washington.
(2) That the requirement is required 808.98 West Virginia.
by compelling local conditions and