FDA (FC of ator gustan Ie 21 {DA Home? Macical Devices! Databases? CFR ~ Code of Federal Regulations Title 241 ‘The information on this page is current as of April 1 2020. For the most up-to-date version of CFR The 21, goto the Electronic Code of Federal Regulations (eCFR).¢ New Search (Cede of Federal Regulations (title 21, volure 8) [Revises ae of April 1, 7020) (cre 21cens20.3) ow? ore abot 2108 TITLE 21--FooD AKO DRUGS Subpart A ~ General Provisions Sec. 420.9 definitions (2) ace means the derai food, Drug, and Cosnetic Act, 20 anended (secs. 201-903, $2 stat. 2040 et (21 0.8.c. 321-393). ALL desinstions sh section 201 of the act shal apply to the (©) Conpiat 1: means any written, electronic, of oral conmuntcation that alleges deficiencies we identity, quality, durability, zeciabinity, safety, eff eness, o: performance of (©) Component nesna any rat material, substance, piace, part, software, firmware, Inbeling, or Assembly which 1e intended to be incivded ag part of the furioheo, packages, and labeled device. (8) Contzot number nesns any distinctive syabols, auch as @ dia (©) Design history fille (DHF ) means a compilation of records wien describes the design history of pssnscensin en governance A203apvanat (FC of ator gustan Ie 21 (2) Design snput means the physical and performance requirements of 2 device that axe used 22a (a) Design outpue means the results of a design effort at each design phase and at the ond of the total design efsore, The finished design ovepst ss the basss for the device master record, The otal Finished design output consists of eke device, ite packaging and labelingy and the device (h) Design review means 5 docunanted, comprehensive, apstenatic examination of a design co evaluate the adequacy of the design requirments, to evalunte the capability of the design to rest these requlzenents, and to Laestity probleas. (2) Device Bistory record (DUR ) means a compilation of secords conteinins (J) Device master zecord (24K } means a canpliation of records containing the procedures and (2) Establish nesna deine, document (in writing or electronically), snd smplesent (2) Finished device means acy device ox accessory to any device that 19 auitable for use or capable Cf cunctioning, wiether or fol it ia packaged, leveled, of sterilized, (=) Lot oF batch mosns one oF nore components oF finished devices that consist of a single type hodely clase, size, conponition, ox softunce version shat are manufactured under easentialay ane conditions and that ate invended to have uniform characteristics and quality within spec (n) Msragenont with oxacutive reepensibitity means those senior srployees of a manufacturer ho have the authority to sataplish of make changes To the manufacturer's quality policy and quality systen. (0) Menufacturer means any pecsor who designe, manufactures, fabricated, stuenbles, or processes = contract sterilization, installation, relaboling, remanufacturing, ropackingy oF spocsfication evelopment, aga initia: aistriputare of foreign entivies peztorming these functions (p) Menufacturing material means any material or substance used in or used to facilitate the fanufacturing prooesn, which ta present in or on the finianed sevice aa a residse or smpursty not By design or intert of the manufacturer (a) Nonconforniey 2 (7) Product moans components, manufacturing materials, ino process devices, finished devices, and returned devle (2) Quatéey means the totality of features and charactertatice that bear on the ability of « device (2) Quabity avait means a systematic, independen: exanination of a manufacturer's quality syatex that 19 peftarmed at defined incervels and at sufficlest frequency to determine whether both petuaconana fi goverpaodictoce te CFR 20 3apvanat (FC of ator gustan Ie 21 (u) Quality poldey means the overall intentions and dicection of an oryanization with respect to (2) Quality aysten means the organizational structure, responsibilities, precedires, preccases, and resources for implementing quality management. («) Renanufacturer means any person who processes, conditions, renovetes, repackage, restores, oF Pecfornance or anfety specifications, 9° invended us (2) Rework seane action tazen on a nonconforming product ao that it Will fuifill the epecitied oR Fequizenents before it is released for distribution (y)_Spocétication means any rewuirenent with which s product, proceas, service, oF other activity mist contorn (2) Validation means confirmation by exanination and provision of objective evidence that the (2) Process validation means establishing by objective evidence that a process consistently produces a reaul: or product meeting ite predetermined apecitications (2) Design validation means extabliahing by cbjectiv with eer necds ard intended saeie) (aa) Verirication means contizmation by exanination and provision of objective evidence cast specified requirements have been fsifilled (eb) fomen cell, Tiassa, of cellar or tiasue-bazed product (HC1/#) regulated ax 2 device means an HeIe ae defined in # 1271-2(@) of this chapter vhac does not mest the criteria an § 227].20(a) and that 19 also regulated as 4 device: (c=) Unique dovice dents fier (UDI) means an identifier thet adequately identifies = device through SS5\diateibutson and are by neering che Foguiromente of § 650,20 of thie chapter. A unique device Saeneitier is composed of (2) A device identitier - & mandatory, fixed poction of & UDI that identifies the apecitic version (2) A production identifier ~ a conditional, variable portion of a UDI that identifies one or mo: of the’ following when included on the label of the device (2) The 1oe oF Batch within which a device was menufactured? (A) The serial miner of a specific devices (610) The expiration date of 4 specific devices Gov the dase & specific device war manstscruree. (¥) For an SC1/P regulated as a device, the distinct Ldentificasion code required by $ 1271.290(0} Of chs chapeee (de) Universal produce case (UEC) moana the product identifier used Fo identify an item sold at retail in the Usited State 61 FR 52654, Oct, 7, 1996, ae amended at 78 FR 96822, Sept. 24, 20231 petuaconana fi goverpaodictoce te CFR 20 3seomacat FC of ara Roguotene Iie 21 Links on this page: http://www aceths.com/beokmark.hp?uS0B-trueky=1528username=féamain http://www. accthis.com/beokmark. oh 5 httos://www.£6a.gov! _https://www.fda.gov/Medical-Devices \éovices/éevice-advice-comprehensive-regulatory-assistance/medical-device-databases https://www.ectrgov/cah-bin/ECFR?page=browse ‘/serips/edrh/cféocs/search/defauk.ctm?FAQ=true httos://www.fda.gov/medical-devices/medical-device-databases/code-federal-regulations-ttle-21-food-and-drugs 2 3 4 5. https://wwu.fda.gov/medic 6 2 8 9, /seripts/edrh/devicesatféa/index.ctm?Search_Term=Defintions¥42E Page Last Updated: 11/10/2020 Note: If you need help accessing information in lfferent file formats, see Instructions for Downloading Viewers and Players Language Assistance Available: espatal | IR2K | Tieng Vigt | BF | Tagalog | Pyeceni | sx! | KreyBl Ay'syan | Francas | Polskl | Portugués | Italiana | Deutsch | BAS |-8 | Enal'sh Accessibilty Contact FDA Careers FDA Basics FOIA No FEAR Act Nondiscrimination Website Policies / Privacy PA U.S. Food and Drug Administration 10803 New Hampshire Avenue Silver Spring, MD 20993, Ph, 1-888-INFO-FDA Contact FDA, TSroo, of For Government Far Press Combination Products Advisory Committees Science & Research Regulatory Information Safety Emergency Preparedness International Programs News & Events Training and Continuing Education Inspections/Complance State & Local Officials Consumers Industry Health Professionals FDA archive if iceacieicad ee 988-463-6332) Links on this page: 1, http://www. adaths.com/bookmark,php?u508=true8y=1528userneme=fdamain 2. htto//www.adethis.com/bookmark. php 3 https://www.féa.gow! pssnscensin en governance A203 asseovacat (FC of ator gustan Ie 21 https://www.fda.gov/Medical-Devices -https://www.[da.gov/medical-devices/evice-advice-comprehensive-regulatory-assistance/medica-device-databases https: /www.ectrgov/coi-bin/ECFR?page=browse Jscripts/edrh/ctéocs/search/default.cfm?FAQstrus https//www. da. gov/medical-cevices/medical-device-databases/code-federal-regulations-ttle-21-food-and-drugs {/seripts/edrh/devicesatida/index.cfm?Search_Term=Definitions%2E pssnscensin en governance A203