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and identify in at least one copy the information that it believes to be trade secret or confidential commercial or financial information.

(3) A summary in sufficient detail that the reader may gain a general understanding of the data and information in the application. The summary shall contain the following information:

(i) Indications for use. A general description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the patient population for which the device is intended.

(ii) Device description. An explanation of how the device functions, the basic scientific concepts that form the basis for the device, and the significant physical and performance characteristics of the device. A brief description of the manufacturing process should be included if it will significantly enhance the reader's understanding of the device. The generic name of the device as well as any proprietary name or trade name should be included.

(iii) Alternative practices and procedures. A description of existing alternative practices or procedures for diagnosing, treating, preventing, curing, or mitigating the disease or condition for which the device is intended.

(iv) Marketing history. A brief description of the foreign and U.S. marketing history, if any, of the device, including a list of all countries in which the device has been marketed and a list of all countries in which the device has been withdrawn from marketing for any reason related to the safety or effectiveness of the device. The description shall include the history of the marketing of the device by the applicant and, if known, the history of the marketing of the device by any other person.

(v) Summary of studies. An abstract of any information or report described in the PMA under paragraph (b)(8)(ii) of this section and a summary of the results of technical data submitted under paragraph (b)(6) of this section. Such summary shall include a description of the objective of the study, a description of the experimental design of the study, a brief description of how the data were collected and analyzed, and a

brief description of the results, whether positive, negative, or inconclusive. This section shall include the following:

(A) A summary of the nonclinical laboratory studies submitted in the application;

(B) A summary of the clinical investigations involving human subjects submitted in the application including a discussion of subject selection and exclusion criteria, study population, study period, safety and effectiveness data, adverse reactions and complications, patient discontinuation, patient complaints, device failures and replacements, results of statistical analyses of the clinical investigations, contraindications and precautions for use of the device, and other information from the clinical investigations as appropriate (any investigation conducted under an IDE shall be identified as such).

(vi) Conclusions drawn from the studies. A discussion demonstrating that the data and information in the application constitute valid scientific evidence within the meaning of $860.7 and provide reasonable assurance that the device is safe and effective for its intended use. A concluding discussion shall present benefit and risk considerations related to the device including a discussion of any adverse effects of the device on health and any proposed additional studies or surveillance the applicant intends to conduct following approval of the PMA.

(4) A complete description of:

(i) The device, including pictorial representations;

(ii) Each of the functional components or ingredients of the device if the device consists of more than one physical component or ingredient;

(iii) The properties of the device relevant to the diagnosis, treatment, prevention, cure, or mitigation of a disease or condition;

(iv) The principles of ope tion of the device; and

(v) The methods used in, and the facilities and controls used for, the manufacture, processing, packing, storage, and, where appropriate, installation of the device, in sufficient detail so that a person generally familiar with current good manufacturing practice can make a knowledgeable judgment about the quality control used in the manufacture of the device.

(5) Reference to any performance standard under section 514 of the act or the Radiation Control for Health and Safety Act of 1968 (42 U.S.C. 263b et seq.) in effect or proposed at the time of the submission and to any voluntary standard that is relevant to any aspect of the safety or effectiveness of the device and that is known to or that should reasonably be known to the applicant. The applicant shall

(i) Provide adequate information to demonstrate how the device meets, or justify any deviation from, any performance standard established under section 514 of the act or under the Radiation Control for Health and Safety Act, and

(ii) Explain any deviation from a voluntary standard.

(6) The following technical sections which shall contain data and information in sufficient detail to permit FDA to determine whether to approve or deny approval of the application:

(i) A section containing results of the nonclinical laboratory studies with the device including microbiological, toxicological, immunological, biocompatibility, stress, wear, shelf life, and other laboratory or animal tests as appropriate. Information on nonclinical laboratory studies shall include statement that each such study was conducted in compliance with part 58, or, if the study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance.

(ii) A section containing results of the clinical investigations involving human subjects with the device including clinical protocols, number of investigators and subjects per investigator, subject selection and exclusion criteria, study population, study period, safety and effectiveness data, adverse reactions and complications, patient discontinuation, patient complaints, device failures and replacements, tabulations of data from all individual subject report forms and copies of such forms for each subject who died during a clinical investigation or who did not complete the investigation, results of statistical analyses of the clinical in

vestigations, device failures and replacements, contraindications and precautions for use of the device, and any other appropriate information from the clinical investigations. Any investigation conducted under an IDE shall be identified as such. Information on clinical investigations involving human subjects shall include the following:

(A) A statement with respect to each study that it either was conducted in compliance with the institutional review board regulations in part 56, or was not subject to the regulations under $56.104 or $56.105, and that it was conducted in compliance with the informed consent regulations in part 50; or if the study was not conducted in compliance with those regulations, a brief statement of the reason for the noncompliance.

(B) A statement that each study was conducted in compliance with part 812 or part 813 concerning sponsors of clinical investigations and clinical investigators, or if the study was not conducted in compliance with those regulations, a brief statement of the reason for the noncompliance.

(7) For a PMA supported solely by data from one investigation, a justification showing that data and other information from a single investigator are sufficient to demonstrate the safety and effectiveness of the device and to ensure reproducibility of test results.

(8)(i) A bibliography of all published reports not submitted under paragraph (b)(6) of this section, whether adverse or supportive, known to or that should reasonably be known to the applicant and that concern the safety or effectiveness of the device.

(ii) An identification, discussion, and analysis of any other data, information, or report relevant to an evaluation of the safety and effectiveness of the device known to or that should reasonably be known to the applicant from any source, foreign or domestic, including information derived from investigations other than those proposed in the application and from commercial marketing experience.

(iii) Copies of such published reports or unpublished information in the possession of or reasonably obtainable by

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the applicant if an FDA advisory com- shall be submitted as a separate secmittee or FDA requests.

tion in the PMA and identified in the (9) One or more samples of the device table of contents. If the justification and its components, if requested by for the omission is not accepted by the FDA. If it is impractical to submit a agency, FDA will so notify the applirequested sample of the device, the ap- cant. plicant shall name the location at (e) The applicant shall periodically which FDA may examine and test one update its pending application with or more devices.

new safety and effectiveness informa(10) Copies of all proposed labeling tion learned about the device from onfor the device. Such labeling may in- going or completed studies that may clude, e.g., instructions for installation reasonably affect an evaluation of the and any information, literature, or ad

safety or effectiveness of the device or vertising that constitutes labeling that may reasonably affect the stateunder section 201(m) of the act.

ment of contraindications, warnings, (11) An environmental assessment

precautions, and adverse reactions in under $25.20(n) prepared in the applica

the draft labeling. The update report ble format in $25.40, unless the action

shall be consistent with the data requalifies for exclusion under $25.30 or

porting provisions of the protocol. The $25.34. If the applicant believes that

applicant shall submit three copies of the action qualifies for exclusion, the

any update report and shall include in PMA shall under $25.15(a) and (d) pro

the report the number assigned by FDA vide information that establishes to

to the PMA. These updates are considFDA's satisfaction that the action re

ered to be amendments to the PMA. quested is included within the excluded

The time frame for review of a PMA category and meets the criteria for the

will not be extended due to the submisapplicable exclusion.

sion of an update report unless the up(12) A financial certification or dis

date is a major amendment under closure statement or both as required

$814.37(c)(1). The applicant shall submit by part 54 of this chapter.

these reports, (13) Such other information as FDA

(1) 3 months after the filing date, may request. If necessary, FDA will obtain the concurrence of the appropriate

(2) Following receipt of an approvFDA advisory committee before re

able letter, and questing additional information.

(3) At any other time as requested by (c) Pertinent information in FDA

FDA. files specifically referred to by an ap- (f) If a color additive subject to secplicant may be incorporated into a tion 706 of the act is used in or on the PMA by reference. Information in a device and has not previously been listmaster file or other information sub

ed for such use, then, in lieu of submitmitted to FDA by a person other than ting a color additive petition under the applicant will not be considered part 71, at the option of the applicant, part of a PMA unless such reference is the information required to be subauthorized in writing by the person mitted under part 71 may be submitted who submitted the information or the as part of the PMA. When submitted as master file. If a master file is not ref- part of the PMA, the information shall erenced within 5 years after the date be submitted in three copies each that it is submitted to FDA, FDA will bound in one or more numbered volreturn the master file to the person umes of reasonable size. A PMA for a who submitted it.

device that contains a color additive (d) If the applicant believes that cer- that is subject to section 706 of the act tain information required under para- will not be approved until the color adgraph (b) of this section to be in a PMA ditive is listed for use in or on the deis not applicable to the device that is vice. the subject of the PMA, and omits any (g) FDA has issued a PMA guidance such information from its PMA, the ap- document to assist the applicant in the plicant shall submit a statement that arrangement and content of a PMA. identifies the omitted information and This guidance document is available on justifies the omission. The statement the Internet at http://www.fda.gov/cdrh

dsma/pmaman/front.html. This guidance document is also available upon request from the Center for Devices and Radiological Health, Division of Small Manufacturers Assistance (HFZ220), 1350 Piccard Dr., Rockville, MD 20850, FAX 301-443–8818.

(h) If you are sending a PMA, PMA amendment, PMA supplement, or correspondence with respect to a PMA, you must send it to the Document Mail Center (HFZ-401), Center for Devices and Radiological Health, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850. (Approved by the Office of Management and Budget under control number 0910-0231) (51 FR 26364, July 22, 1986; 51 FR 40415, Nov. 7, 1986, as amended at 51 FR 43344, Dec. 2, 1986; 55 FR 11169, Mar. 27, 1990; 62 FR 40600, July 29, 1997; 63 FR 5253, Feb. 2, 1998; 65 FR 17137, Mar. 31, 2000; 65 FR 56480, Sept. 19, 2000)

the number of days that elapse between the date of such request and the date that FDA receives the written response declining to submit the requested amendment.

(d) An applicant may on its own initiative withdraw a PMA or PMA supplement. If FDA requests an applicant to submit a PMA amendment and a written response to FDA's request is not received within 180 days of the date of the request, FDA will consider the pending PMA or PMA supplement to be withdrawn voluntarily by the applicant.

(e) An applicant may resubmit a PMA or PMA supplement after withdrawing it or after it is considered withdrawn under paragraph (d) of this section, or after FDA has refused to accept it for filing, or has denied approval of the PMA or PMA supplement. A resubmitted PMA or PMA supplement shall comply with the requirements of $814.20 or $814.39, respectively, and shall include the PMA number assigned to the original submission and the applicant's reasons for resubmission of the PMA or PMA supplement.

$814.37 PMA amendments and resub

mitted PMA's. (a) An applicant may amend a pending PMA or PMA supplement to revise existing information or provide additional information.

(b) FDA may request the applicant to amend a PMA or PMA supplement with any information regarding the device that is necessary for FDA or the appropriate advisory committee to complete the review of the PMA or PMA supplement.

(c) A PMA amendment submitted to FDA shall include the PMA or PMA supplement number assigned to the original submission and, if submitted on the applicant's own initiative, the reason for submitting the amendment. FDA may extend the time required for its review of the PMA, or PMA supplement, as follows:

(1) If the applicant on its own initiative or at FDA's request submits a major PMA amendment (e.g.,

an amendment that contains significant new data from a previously unreported study, significant updated data from a previously reported study, detailed new analyses of previously submitted data, or significant required information previously omitted), the review period may be extended up to 180 days.

(2) If an applicant declines to submit a major amendment requested by FDA, the review period may be extended for

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8814.39 PMA supplements.

(a) After FDA's approval of a PMA, an applicant shall submit a PMA supplement for review and approval by FDA before making a change affecting the safety or effectiveness of the device for which the applicant has an approved PMA, unless the change is of a type for which FDA, under paragraph (e) of this section, has advised that an alternate submission is permitted or is of type which, under section 515(d)(6)(A) of the act and paragraph (f) of this section, does not require a PMA supplement under this paragraph. While the burden for determining whether a supplement is required is primarily on the PMA holder, changes for which an applicant shall submit a PMA supplement include, but are not limited to, the following types of changes if they affect the safety or effectiveness of the device:

(1) New indications for use of the device.

(2) Labeling changes.

(3) The use of a different facility or (d)(2) of this section that enhances the establishment to manufacture, process, safety of the device or the safety in the or package the device.

use of the device may be placed into ef(4) Changes in sterilization proce- fect by the applicant prior to the redures.

ceipt under $814.17 of a written FDA (5) Changes in packaging.

order approving the PMA supplement (6) Changes in the performance or de

provided that: sign specifications, circuits, compo- (i) The PMA supplement and its mailnents, ingredients, principle of oper

ing cover are plainly marked “Special ation, or physical layout of the device.

PMA Supplement Changes Being Ef(7) Extension of the expiration date

fected"; of the device based on data obtained

(ii) The PMA supplement provides a under a new or revised stability or sterility testing protocol that has not

full explanation of the basis for the

changes; been approved by FDA. If the protocol has been approved, the change shall be

(iii) The applicant has received acreported to FDA under paragraph (b) of

knowledgement from FDA of receipt of this section.

the supplement; and (b) An applicant may make a change

(iv) The PMA supplement specifically in a device after FDA's approval of a

identifies the date that such changes PMA for the device without submitting

are being effected. a PMA supplement if the change does

(2) The following changes are pernot affect the device's safety or effec

mitted by paragraph (d)(1) of this sectiveness and the change is reported to

tion: FDA in postapproval periodic reports (i) Labeling changes that add or required as a condition to approval of strengthen a contraindication, warnthe device, e.g., an editorial change in ing, precaution, or information about labeling which does not affect the safe- an adverse reaction. ty or effectiveness of the device.

(ii) Labeling changes that add or (c) All procedures and actions that strengthen an instruction that is inapply to an application under $814.20 tended to enhance the safe use of the also apply to PMA supplements except device. that the information required in a sup

(iii) Labeling changes that delete plement is limited to that needed to

misleading, false, or unsupported indisupport the change. A summary under

cations. $814.20(b)(3) is required for only a sup

(iv) Changes in quality controls or plement submitted for new indications

manufacturing process that add a new for use of the device, significant

specification or test method, or otherchanges in the performance or design

wise provide additional assurance of specifications, circuits, components,

purity, identity, strength, reliingredients, principles of operation, or physical layout of the device, or when

ability of the device. otherwise required by FDA. The appli

(e) FDA will identify a change to a cant shall submit three copies of a

device for which an applicant has an PMA supplement and shall include in

approved PMA and for which a PMA formation relevant to the proposed

supplement under paragraph (a) is not changes in the device. A PMA supple

required. FDA will identify such a ment shall include a separate section

change in an advisory opinion under that identifies each change for which

$10.85, if the change applies to a geapproval is being requested and ex

neric type of device, or in correspondplains the reason for each such change. gence to the applicant, if the change apThe applicant shall submit additional plies only to the applicant's device. copies and additional information if re

FDA will require that a change for quested by FDA. The time frames for which a PMA supplement under parareview of, and FDA action on, a PMA graph (a) is not required be reported to supplement are the same as those pro

FDA in vided in $814.40 for a PMA.

(1) A periodic report under $814.84 or (d)(1) After FDA approves a PMA, (2) A 30-day PMA supplement under any change described in paragraph this paragraph.

or

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