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820.25 Personnel.

Subpart C-Design Controls 820.30 Design controls.

Subpart D-Document Controls 820.40 Document controls.

Subpart E-Purchasing Controls 820.50 Purchasing controls.

Subpart F-Identification and Traceability

820.60 Identification. 820.65 Traceability.

device together with an explanation of the basis for the estimate;

(iv) Information describing the applicant's clinical experience with the device since the HDE was initially approved. This information shall include safety information that is known or reasonably should be known to the applicant, medical device reports made under part 803 of this chapter, any data generated from the postmarketing studies, and information (whether published or unpublished) that is known or reasonably expected to be known by the applicant that may affect an evaluation of the safety of the device or that may affect the statement of contraindications, warnings, precautions, and adverse reactions in the device's labeling; and

(v) A summary of any changes made to the device in accordance with supplements submitted under $814.108. If information provided in the periodic reports, or any other information in the possession of FDA, gives the agency reason to believe that a device raises public health concerns or that the criteria for exemption are no longer met, the agency may require the HDE holder to submit additional information to demonstrate continued compliance with the HDE requirements.

(2) Other. An HDE holder shall maintain records of the names and addresses of the facilities to which the HUD has been shipped, correspondence with reviewing IRB's, as well as any other information requested by a reviewing IRB or FDA. Such records shall be maintained in accordance with the HDE approval order. [61 FR 33244, June 26, 1996, as amended at 63 FR 59221, Nov. 3, 1998, 71 FR 16228, Mar. 31, 2006]

Subpart G-Production and Process

Controls 820.70 Production and process controls. 820.72 Inspection, measuring, and tes!

equipment. 820.75 Process validation.

Subpart H-Acceptance Activities 820.80 Receiving, in-process, and finished

device acceptance. 820.86 Acceptance status.

Subpart I-Nonconforming Product 820.90 Nonconforming product. Subpart 1-Corrective and Preventive

Action

820.100 Corrective and preventive action.

Subpart K-Labeling and Packaging

Control

820.120 Device labeling. 820.130 Device packaging.

Subpart L-Handling, Storage, Distribution,

and Installation

PART 820—QUALITY SYSTEM

REGULATION

820.140 Handling. 820.150 Storage. 820.160 Distribution. 820.170 Installation.

[blocks in formation]

Subpart 0—Statistical Techniques forth in part 1271 subpart C of this 820.250 Statistical techniques.

chapter and applicable current good

tissue practice procedures in part 1271 AUTHORITY: 21 U.S.C. 351, 352, 360, 3600, 3600,

subpart D of this chapter. In the event 360e, 360h, 3600, 360j, 3601, 371, 374, 381, 383; 42

of a conflict between applicable regulaU.S.C. 216, 262, 263a, 264.

tions in part 1271 and in other parts of SOURCE: 61 FR 52654, Oct. 7, 1996, unless

this chapter, the regulation specifiotherwise noted.

cally applicable to the device in ques

tion shall supersede the more general. Subpart A-General Provisions

(2) The provisions of this part shall $820.1 Scope.

be applicable to any finished device as

defined in this part, intended for (a) Applicability. (1) Current good

human use, that is manufactured, immanufacturing practice (CGMP) re

ported, or offered for import in any quirements are set forth in this quality

State or Territory of the United system regulation. The requirements

States, the District of Columbia, or the in this part govern the methods used

Commonwealth of Puerto Rico. in, and the facilities and controls used for, the design, manufacture, pack

(3) In this regulation the term aging, labeling, storage, installation,

where appropriate" is used several and servicing of all finished devices in

times. When a requirement is qualified tended for human use. The require

by "where appropriate," it is deemed ments in this part are intended to en to be “appropriate” unless the manusure that finished devices will be safe facturer can document justification and effective and otherwise in compli otherwise. A requirement is “approance with the Federal Food, Drug, and priate" if nonimplementation could Cosmetic Act (the act). This part es- reasonably be expected to result in the tablishes basic requirements applicable product not meeting its specified reto manufacturers of finished medical quirements or the manufacturer not devices. If a manufacturer engages in being able to carry out any necessary only some operations subject to the re corrective action. quirements in this part, and not in oth (b) The quality system regulation in ers, that manufacturer need only com

this part supplements regulations in ply with those requirements applicable other parts of this chapter except to the operations in which it is en

where explicitly stated otherwise. In gaged. With respect to class I devices,

the event of a conflict between applicadesign controls apply only to those de

ble regulations in this part and in vices listed in $ 820.30(a)(2). This regula

other parts of this chapter, the regulation does not apply to manufacturers

tions specifically applicable to the deof components or parts of finished de

vice in question shall supersede any vices, but such manufacturers are en

other generally applicable requirecouraged to use appropriate provisions

ments. of this regulation as guidance. Manu

(c) Authority. Part 820 is established facturers of human blood and blood components are not subject to this

and issued under authority of sections part, but are subject to part 606 of this

501, 502, 510, 513, 514, 515, 518, 519, 520, chapter. Manufacturers of human cells,

522, 701, 704, 801, 803 of the act (21 U.S.C. tissues, and cellular and tissue-based

351, 352, 360, 3600, 3600, 360e, 360h, 360i, products (HCT/Ps), as defined in

360j, 3601, 371, 374, 381, 383). The failure $1271.3(d) of this chapter, that are med

to comply with any applicable proviical devices (subject to premarket re

sion in this part renders a device adulview or notification, or exempt from terated under section 501(h) of the act. notification, under an application sub Such a device, as well as any person remitted under the device provisions of sponsible for the failure to comply, is the act or under a biological product li- subject to regulatory action. cense application under section 351 of (d) Foreign manufacturers. If a manuthe Public Health Service Act) are sub- facturer who offers devices for import ject to this part and are also subject to into the United States refuses to perthe donor-eligibility procedures set mit or allow the completion of a Food and Drug Administration (FDA) inspec- a device after it is released for distion of the foreign facility for the pur- tribution. pose of determining compliance with (c) Component means any raw matethis part, it shall appear for purposes rial, substance, piece, part, software. of section 801(a) of the act, that the firmware, labeling, or assembly which methods used in, and the facilities and is intended to be included as part of the controls used for, the design, manufac- finished, packaged, and labeled device. ture, packaging, labeling, storage, in- (d) Control number means any distincstallation, or servicing of any devices tive symbols, such as a distinctive produced at such facility that are of- combination of letters or numbers, or fered for import into the United States both, from which the history of the do not conform to the requirements of manufacturing, packaging, labeling, section 520(f) of the act and this part and distribution of a unit, lot, or batch and that the devices manufactured at of finished devices can be determined. that facility are adulterated under sec (e) Design history file (DHF) means a tion 501(h) of the act.

compilation of records which describes (e) Exemptions or variances. (1) Any the design history of a finished device. person who wishes to petition for an

petition for an (f) Design input means the physical exemption or variance from any device

and performance requirements of a dequality system requirement is subject vice that are used as a basis for device to the requirements of section 520(f)(2) of the act. Petitions for an exemption (g) Design output means the results of or variance shall be submitted accord a design effort at each design phase and ing to the procedures set forth in $10.30 at the end of the total design effort. of this chapter, the FDA's administra The finished design output is the basis tive procedures. Guidance is available for the device master record. The total from the Center for Devices and Radio finished design output consists of the logical Health, Division of Small Man device, its packaging and labeling, and ufacturers Assistance (HFZ-220), 1350 the device master record. Piccard Dr., Rockville, MD 20850, (h) Design review means a docuU.S.A., telephone 1-800-638-2041 or 1 mented, comprehensive, systematic ex301-443-6597, FAX 301-443-8818.

amination of a design to evaluate the (2) FDA may initiate and grant a

adequacy of the design requirements, variance from any device quality sys

to evaluate the capability of the design tem requirement when the agency de

to meet these requirements, and to termines that such variance is in the

identify problems. best interest of the public health. Such

(i) Device history record (DHR) means variance will remain in effect only so a compilation of records containing the long as there remains a public health

production history of a finished device. need for the device and the device

(j) Device master record (DMR) means would not likely be made sufficiently

a compilation of records containing the available without the variance.

procedures and specifications for a fin

ished device. [61 FR 52654, Oct. 7, 1996, as amended at 65 FR (k) Establish means define, document 17136, Mar. 31, 2000; 65 FR 66636, Nov. 7, 2000; (in writing or electronically), and im69 FR 29829, May 25, 2005)

plement. $ 820.3 Definitions.

(1) Finished device means any device

or accessory to any device that is suit(a) Act means the Federal Food, able for use or capable of functioning, Drug, and Cosmetic Act, as amended whether or not it is packaged, labeled, (secs. 201-903, 52 Stat. 1040 et seq., as or sterilized. amended (21 U.S.C. 321-394)). All defini (m) Lot or batch means one or more tions in section 201 of the act shall components or finished devices that apply to the regulations in this part. consist of a single type, model, class,

(b) Complaint means any written, size, composition, or software version electronic, or oral communication that that are manufactured under essenalleges deficiencies related to the iden- tially the same conditions and that are tity, quality durability, reliability, intended to have uniform characterissafety, effectiveness, or performance of tics and quality within specified limits. (n) Management with executive respon- repackages, restores, or does any other sibility means those senior employees of act to a finished device that signifia manufacturer who have the authority cantly changes the finished device's to establish or make changes to the performance or safety specifications, manufacturer's quality policy and or intended use. quality system.

(x) Rework means action taken on a (0) Manufacturer means any person nonconforming product so that it will who designs, manufactures, fabricates, fulfill the specified DMR requirements assembles, or processes a finished de- before it is released for distribution. vice. Manufacturer includes but is not (y) Specification means any requirelimited to those who perform the func- ment with which a product, process, tions of contract sterilization, installa- service, or other activity must contion, relabeling, remanufacturing, re

form. packing, or specification development, (z) Validation means confirmation by and initial distributors of foreign enti- examination and provision of objective ties performing these functions.

evidence that the particular require(p) Manufacturing material means any ments for a specific intended use can material or substance used in or used be consistently fulfilled. to facilitate the manufacturing proc (1) Process validation means estabess, a concomitant constituent, or a lishing by objective evidence that a byproduct constituent produced during process consistently produces a result the manufacturing process, which is

or product meeting its predetermined present in or on the finished device as

specifications. a residue or impurity not by design or

(2) Design validation means estabintent of the manufacturer.

lishing by objective evidence that de(q) Nonconformity means the non- vice specifications conform with user fulfillment of a specified requirement. needs and intended use(s).

(r) Product means components, manu (aa) Verification means confirmation facturing materials, in- process de

by examination and provision of objecvices, finished devices, and returned

tive evidence that specified requiredevices.

ments have been fulfilled. (8) Quality means the totality of features and characteristics that bear on $ 820.5 Quality system. the ability of a device to satisfy fit

Each manufacturer shall establish ness-for-use, including safety and per

and maintain a quality system that is formance.

appropriate for the specific medical de(t) Quality audit means a systematic,

vice(s) designed or manufactured, and independent examination of a manufac

that meets the requirements of this turer's quality system that is per

part. formed at defined intervals and at sufficient frequency to determine whether both quality system activities and the

Subpart B-Quality System results of such activities comply with

Requirements quality system procedures, that these

$ 820.20 Management responsibility. procedures are implemented effectively, and that these procedures are (a) Quality policy. Management with suitable to achieve quality system ob executive responsibility shall establish jectives.

its policy and objectives for, and com(u) Quality policy means the overall mitment to, quality. Management with intentions and direction of an organi- executive responsibility shall ensure zation with respect to quality, as es- that the quality policy is understood, tablished by management with execu implemented, and maintained at all tive responsibility.

levels of the organization. (v) Quality system means the organi (b) Organization. Each manufacturer zational structure, responsibilities, shall establish and maintain an adeprocedures, processes, and resources for quate organizational structure to enimplementing quality management. sure that devices are designed and pro

(w) Remanufacturer means any person duced in accordance with the requirewho processes, conditions, renovates, ments of this part.

$820.22 Quality audit.

Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system. Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited. Corrective action(s), including a reaudit of deficient matters, shall be taken when necessary. A report of the results of each quality audit, and reaudit(s) where taken, shall be made and such reports shall be reviewed by management having responsibility for the matters audited. The dates and results of quality audits and reaudits shall be documented.

(1) Responsibility and authority. Each manufacturer shall establish the appropriate responsibility, authority, and interrelation of all personnel who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks.

(2) Resources. Each manufacturer shall provide adequate resources, including the assignment of trained personnel, for management, performance of work, and assessment activities, including internal quality audits, to meet the requirements of this part.

(3) Management representative. Man agement with executive responsibility shall appoint, and document such appointment of, a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for:

(i) Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and

(ii) Reporting on the performance of the quality system to management with executive responsibility for review.

(c) Management review. Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer's established quality policy and objectives. The dates and results of quality system reviews shall be documented.

(d) Quality planning. Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured. The manufacturer shall establish how the requirements for quality will be met.

(e) Quality system procedures. Each manufacturer shall establish quality system procedures and instructions. An outline of the structure of the documentation used in the quality system shall be established where appropriate.

$ 820.25 Personnel.

(a) General. Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that activities required by this part are correctly performed.

(b) Training. Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented.

(1) As part of their training, personnel shall be made aware of device defects which may occur from the improper performance of their specific jobs.

(2) Personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job functions.

Subpart C-Design Controls

$ 820.30 Design controls.

(a) General. (1) Each manufacturer of any class III or class II device, and the class I devices listed in paragraph (a)(2) of this section, shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.

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