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vice is a significant risk device, and the sponsor had proposed that the IRB consider the device not to be a significant risk device, the sponsor shall submit to FDA a report of the IRB's determination within 5 working days after the sponsor first learns of the IRB's determination.

(10) Other. A sponsor shall, upon request by a reviewing IRB or FDA, provide accurate, complete, and current information about any aspect of the investigation. (45 FR 3751, Jan. 18, 1980, as amended at 45 FR 58843, Sept. 5, 1980; 48 FR 15622, Apr. 12, 1983; 62 FR 48948, Sept. 18, 1997)

PART 813 [RESERVED

PART 814-PREMARKET APPROVAL

OF MEDICAL DEVICES

Subpart A-General

of an investigation or a part of an investigation by a reviewing IRB within 5 working days after receipt of the withdrawal of approval.

(3) Withdrawal of FDA approval. A sponsor shall notify all reviewing IRB's and participating investigators of any withdrawal of FDA approval of the investigation, and shall do so within 5 working days after receipt of notice of the withdrawal of approval.

(4) Current investigator list. A sponsor shall submit to FDA, at 6-month intervals, a current list of the names and addresses of all investigators participating in the investigation. The sponsor shall submit the first such list 6 months after FDA approval.

(5) Progress reports. At regular intervals, and at least yearly, a sponsor shall submit progress reports to all reviewing IRB's. In the case of a significant risk device, a sponsor shall also submit progress reports to FDA. A sponsor of a treatment IDE shall submit semi-annual progress reports to all reviewing IRB's and FDA in accordance with 8812.36(f) and annual reports in accordance with this section.

(6) Recall and device disposition. A sponsor shall notify FDA and all reviewing IRB's of any request that an investigator return, repair, or otherwise dispose of any units of a device. Such notice shall occur within 30 working days after the request is made and shall state why the request was made.

(7) Final report. In the case of a significant risk device, the sponsor shall notify FDA within 30 working days of the completion or termination of the investigation and shall submit a final report to FDA and all reviewing the IRB's and participating investigators within 6 months after completion or termination. In the case of a device that is not a significant risk device, the sponsor shall submit a final report to all reviewing IRB's within 6 months after termination or completion.

(8) Informed consent. A sponsor shall submit to FDA a copy of any report by an investigator under paragraph (a)(5) of this section of use of a device without obtaining informed consent, within 5 working days of receipt of notice of such use.

(9) Significant risk device determinations. If an IRB determines that a de

Sec. 814.1 Scope. 814.2 Purpose. 814.3 Definitions. 814.9 Confidentiality of data and informa

tion in a premarket approval application

(PMA) file. 814.15 Research conducted outside the

United States. 814.17 Service of orders. 814.19 Product development protocol (PDP). Subpart B-Premarket Approval

Application (PMA) 814.20 Application. 814.37 PMA amendments and resubmitted

PMA's. 814.39 PMA supplements.

Subpart C-FDA Action on a PMA 814.40 Time frames for reviewing a PMA. 814.42 Filing a PMA. 814.44 Procedures for review of a PMA. 814.45 Denial of approval of a PMA. 814.46 Withdrawal of approval of a PMA. 814.47 Temporary suspension of approval of

a PMA.

Subpart D-Administrative Review

[Reserved)

Subpart E-Postapproval Requirements

814.80 General. 814.82 Postapproval requirements. 814.84 Reports.

Subparts F-G (Reserved)

Subpart H-Humanitarian Use Devices

(d) This part amends the conditions to approval for any PMA approved before the effective date of this part. Any condition to approval for an approved PMA that is inconsistent with this part is revoked. Any condition to approval for an approved PMA that is consistent with this part remains in effect.

814.100 Purpose and scope. 814.102 Designation of HUD status. 814.104 Original applications. 814.106 HDE amendments and resubmitted

HDE's. 814.108 Supplemental applications. 814.110 New indications for use. 814.112 Filing an HDE. 814.114 Timeframes for reviewing an HDE. 814.116 Procedures for review of an HDE. 814.118 Denial of approval or withdrawal of

approval of an HDE. 814.120 Temporary suspension of approval of

an HDE. 814.122 Confidentiality of data and informa

tion. 814.124 Institutional Review Board require

ments. 814.126 Postapproval requirements and re

ports. AUTHORITY: 21 U.S.C. 351, 352, 353, 360, 360c360j, 371, 372, 373, 374, 375, 379, 379e, 381.

SOURCE: 51 FR 26364, July 22, 1986, unless otherwise noted.

$814.2 Purpose.

The purpose of this part is to establish an efficient and thorough device review process

(a) To facilitate the approval of PMA's for devices that have been shown to be safe and effective and that otherwise meet the statutory criteria for approval; and

(b) To ensure the disapproval of PMA's for devices that have not been shown to be safe and effective or that do not otherwise meet the statutory criteria for approval. This part shall be construed in light of these objectives.

Subpart A-General $814.1 Scope.

(a) This part implements section 515 of the act by providing procedures for the premarket approval of medical devices intended for human use.

(b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.

(C) This part applies to any class III medical device, unless exempt under section 520(g) of the act, that:

(1) Was not on the market (introduced or delivered for introduction into commerce for commercial distribution) before May 28, 1976, and is not substantially equivalent to a device on the market before May 28, 1976, or to a device first marketed on, or after that date, which has been classified into class I or class II; or

(2) Is required to have an approved premarket approval application (PMA) or a declared completed product development protocol under a regulation issued under section 515(b) of the act; or

(3) Was regulated by FDA as a new drug or antibiotic drug before May 28, 1976, and therefore is governed by section 520(1) of the act.

$ 814.3 Definitions.

For the purposes of this part:

(a) Act means the Federal Food, Drug, and Cosmetic Act (sections 201902, 52 Stat. 1040 et seq., as amended (21 U.S.C. 321–392)).

(b) FDA means the Food and Drug Administration.

(c) IDE means an approved or considered approved investigational device exemption under section 520(g) of the act and parts 812 and 813.

(d) Master file means a reference source that a person submits to FDA. A master file may contain detailed information on a specific manufacturing facility, process, methodology, or component used in the manufacture, processing, or packaging of a medical device.

(e) PMA means any premarket approval application for a class III medical device, including all information submitted with or incorporated by reference therein. “PMA” includes a new drug application for a device under section 520(1) of the act.

(f) PMA amendment means information an applicant submits to FDA to modify a pending PMA or a pending PMA supplement.

(g) PMA supplement means a supplemental application to an approved

a

PMA for approval of a change or modification in a class III medical device, including all information submitted with or incorporated by reference therein.

(h) Person includes any individual, partnership, corporation, association, scientific or academic establishment, Government agency, or organizational unit thereof, or any other legal entity.

(i) Statement of material fact means a representation that tends to show that the safety or effectiveness of a device is more probable than it would be in the absence of such a representation. A false affirmation or silence or an omission that would lead a reasonable person to draw a particular conclusion as to the safety or effectiveness of a device also may be a false statement of material fact, even if the statement was not intended by the person making it to be misleading or to have any probative effect.

(j) 30-day PMA supplement means a supplemental application to an approved PMA in accordance with $814.39(e).

(k) Reasonable probability means that it is more likely than not that an event will occur.

(1) Serious, adverse health consequences means any significant adverse experience, including those which may be either life-threatening or involve permanent or long term injuries, but excluding injuries that are nonlife-threatening and that are temporary and reasonably reversible.

(m) HDE means a premarket approval application submitted pursuant to this subpart seeking a humanitarian device exemption from the effectiveness requirements of sections 514 and 515 of the act authorized by section 520(m)(2) of the act.

(n) HUD (humanitarian use device) means a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. (51 FR 26364, July 22, 1986, as amended at 61 FR 15190, Apr. 5, 1996; 61 FR 33244, June 26, 1996]

8814.9 Confidentiality of data and in

formation in a premarket approval

application (PMA) file. (a) A "PMA file" includes all data and information submitted with or incorporated by reference in the PMA, any IDE incorporated into the PMA, any PMA supplement, any report under $ 814.82, any master file, or any other related submission. Any record in the PMA file will be available for public disclosure in accordance with the provisions of this section and part 20. The confidentiality of information in color additive petition submitted as part of a PMA is governed by $71.15.

(b) The existence of a PMA file may not be disclosed by FDA before an approval order is issued to the applicant unless it previously has been publicly disclosed or acknowledged.

(c) If the existence of a PMA file has not been publicly disclosed or acknowledged, data or information in the PMA file are not available for public disclosure.

(d)(1) If the existence of a PMA file has been publicly disclosed or acknowledged before an order approving, or an order denying approval of the PMA is issued, data or information contained in the file are not available for public disclosure before such order issues. FDA may, however, disclose a summary of portions of the safety and effectiveness data before an approval order or an order denying approval of the PMA issues if disclosure is relevant to public consideration of a specific pending issue.

(2) Notwithstanding paragraph (d)(1) of this section, FDA will make available to the public upon request the information in the IDE that was required to be filed in Docket Number 95S-0158 in the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, for investigations involving an exception from informed consent under $50.24 of this chapter. Persons wishing to request this information shall submit a request under the Freedom of Information Act.

(e) Upon issuance of an order approving, or an order denying approval of any PMA, FDA will make available to the public the fact of the existence of

as

the PMA and a detailed summary of in- cret or confidential commercial or fiformation submitted to FDA respect nancial information under $20.61: ing the safety and effectiveness of the (1) The PMA has been abandoned. device that is the subject of the PMA FDA will consider a PMA abandoned if: and that is the basis for the order.

(i)(A) The applicant fails to respond (1) After FDA issues an order approv- to a request for additional information ing, or an order denying approval of within 180 days after the date FDA any PMA, the following data and infor- issues the request or mation in the PMA file are imme- (B) Other circumstances indicate diately available for public disclosure: that further work is not being under(1) All safety and effectiveness data

taken with respect to it, and and information previously disclosed to

(ii) The applicant fails to commuthe public, as such disclosure is defined

nicate with FDA within 7 days after in $ 20.81.

the date on which FDA notifies the ap(2) Any protocol for a test or study

plicant that the PMA appears to have

been abandoned. unless the protocol is shown to constitute trade secret or confidential

(2) An order denying approval of the commercial or financial information

PMA has issued, and all legal appeals under $20.61.

have been exhausted.

(3) An order withdrawing approval of (3) Any adverse reaction report, prod

the PMA has issued, and all legal apuct experience report, consumer com

peals have been exhausted. plaint, and other similar data and in

(4) The device has been reclassified. formation, after deletion of:

(5) The device has been found to be (i) Any information that constitutes

substantially equivalent to a class I or trade secret or confidential commer

class II device. cial or financial information under

(6) The PMA is considered volun$20.61; and

tarily withdrawn under $814.44(g). (ii) Any personnel, medical, and simi

(h) The following data and informalar information disclosure of which tion in a PMA file are not available for would constitute a clearly unwarranted public disclosure unless they have been invasion of personal privacy under previously disclosed to the public, as $20.63; provided, however, that except such disclosure is defined in $ 20.81, or for the information that constitutes they relate to a device for which a trade secret or confidential commer- PMA has been abandoned and they no cial or financial information under longer represent a trade secret or con$20.61, FDA will disclose to a patient fidential commercial or financial inforwho requests a report all the informa- mation as defined in 8 20.61: tion in the report concerning that pa- (1) Manufacturing methods or proctient.

esses, including quality control proce(4) A list of components previously dures. disclosed to the public, as such disclo- (2) Production, sales, distribution, sure is defined in $20.81.

and similar data and information, ex(5) An assay method or other analyt- cept that any compilation of such data ical method, unless it does not serve and information aggregated and preany regulatory purpose and is shown to pared in a way that does not reveal fall within the exemption in $20.61 for data or information which are not trade secret or confidential commer- available for public disclosure under cial or financial information.

this provision is available for public (6) All correspondence and written disclosure. summaries of oral discussions relating

(3) Quantitative or semiquantitative to the PMA file, in accordance with the

formulas. provisions of 88 20.103 and 20.104.

(51 FR 26364, July 22, 1986, as amended at 61 (g) All safety and effectiveness data FR 51531, Oct. 2, 1996) and other information not previously disclosed to the public are available for

8814.15 Research conducted outside public disclosure if any one of the fol

the United States. lowing events occurs and the data and (a) A study conducted outside the information do not constitute trade se- United States submitted in support of

a PMA and conducted under an IDE based solely on foreign data will be shall comply with part 812. A study sought. conducted outside the United States

(Approved by the Office of Management and submitted in support of a PMA and not

Budget under control number 0910-0231) conducted under an IDE shall comply

(51 FR 26364, July 22, 1986; 51 FR 40415, Nov. with the provisions in paragraph (b) or

7, 1986, as amended at 51 FR 43344, Dec. 2, (C) of this section, as applicable.

1986] (b) Research begun on or after effective date. FDA will accept studies sub- $814.17 Service of orders. mitted in support of a PMA which have

Orders issued under this part will be been conducted outside the United

served in person by a designated officer States and begun on or after November

or employee of FDA on, or by reg19, 1986, if the data are valid and the in

istered mail to, the applicant or the vestigator has conducted the studies in

designated agent at the applicant's or conformance with the “Declaration of designated agent's last known address Helsinki" or the laws and regulations in FDA's records. of the country in which the research is conducted, whichever accords greater

$814.19 Product development protocol protection to the human subjects. If

(PDP). the standards of the country are used, A class III device for which a product the applicant shall state in detail any development protocol has been dedifferences between those standards clared completed by FDA under this and the "Declaration of Helsinki" and chapter will be considered to have an explain why they offer greater protec- approved PMA. tion to the human subjects.

(c) Research begun before effective Subpart B-Premarket Approval date. FDA will accept studies sub

Application (PMA) mitted in support of a PMA which have been conducted outside the United

$814.20 Application. States and begun before November 19,

(a) The applicant or an authorized 1986, if FDA is satisfied that the data

representative shall sign the PMA. If are scientifically valid and that the the applicant does not reside or have a rights, safety, and welfare of human place of business within the United subjects have not been violated.

States, the PMA shall be countersigned (d) As sole basis for marketing approval. by an authorized representative residA PMA based solely on foreign clinical ing or maintaining a place of business data and otherwise meeting the cri- in the United States and shall identify teria for approval under this part may

the representative's name and address. be approved if:

(b) Unless the applicant justifies an (1) The foreign data are applicable to

omission in accordance with paragraph the U.S. population and U.S. medical

(d) of this section, a PMA shall include: practice;

(1) The name and address of the ap(2) The studies have been performed

plicant. by clinical investigators of recognized

(2) A table of contents that specifies competence; and

the volume and page number for each

item referred to in the table. A PMA (3) The data may be considered valid

shall include separate sections on nonwithout the need for an on-site inspec

clinical laboratory studies and on clintion by FDA or, if FDA considers such

ical investigations involving human an inspection to be necessary, FDA can

subjects. A PMA shall be submitted in validate the data through an on-site in

six copies each bound in one or more spection or other appropriate means. numbered volumes of reasonable size.

(e) Consultation between FDA and ap- The applicant shall include informaplicants. Applicants are encouraged to tion that it believes to be trade secret meet with FDA officials in a “pre- or confidential commercial or financial submission" meeting when approval information in all copies of the PMA

194-069 D-01--5

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