§ 820.1
`
`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 J—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
`
`820.140 Handling.
`820.150 Storage.
`820.160 Distribution.
`820.170 Installation.
`
`Subpart M—Records
`
`820.180 General requirements.
`820.181 Device master record.
`820.184 Device history record.
`820.186 Quality system record.
`820.198 Complaint files.
`
`Subpart N—Servicing
`
`820.200 Servicing.
`
`Subpart O—Statistical Techniques
`
`820.250 Statistical techniques.
`AUTHORITY: 21 U.S.C. 351, 352, 360, 360c, 360d,
`360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383.
`EFFECTIVE DATE NOTE: At 69 FR 29829, May
`25, 2004, the authority citation for part 1271
`was revised, effective May 25, 2005. For the
`convenience of the user, the revised text is
`set forth as follows:
`AUTHORITY: 21 U.S.C. 351, 352, 360, 360c, 360d,
`360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383; 42
`U.S.C. 216, 262, 263a, 264.
`SOURCE: 61 FR 52654, Oct. 7, 1996, unless
`otherwise noted.
`
`Subpart A—General Provisions
`§ 820.1 Scope.
`(a) Applicability. (1) Current good
`manufacturing practice (CGMP) re-
`quirements are set forth in this quality
`system regulation. The requirements
`
`21 CFR Ch. I (4–1–05 Edition)
`
`in this part govern the methods used
`in, and the facilities and controls used
`for, the design, manufacture, pack-
`aging, labeling, storage, installation,
`and servicing of all finished devices in-
`tended for human use. The require-
`ments in this part are intended to en-
`sure that finished devices will be safe
`and effective and otherwise in compli-
`ance with the Federal Food, Drug, and
`Cosmetic Act (the act). This part es-
`tablishes basic requirements applicable
`to manufacturers of finished medical
`devices. If a manufacturer engages in
`only some operations subject to the re-
`quirements in this part, and not in oth-
`ers, that manufacturer need only com-
`ply with those requirements applicable
`to the operations in which it is en-
`gaged. With respect to class I devices,
`design controls apply only to those de-
`vices listed in § 820.30(a)(2). This regula-
`tion does not apply to manufacturers
`of components or parts of finished de-
`vices, but such manufacturers are en-
`couraged to use appropriate provisions
`of this regulation as guidance. Manu-
`facturers of human blood and blood
`components are not subject to this
`part, but are subject to part 606 of this
`chapter.
`(2) The provisions of this part shall
`be applicable to any finished device as
`defined in this part, intended for
`human use, that is manufactured, im-
`ported, or offered for import in any
`State or Territory of the United
`States, the District of Columbia, or the
`Commonwealth of Puerto Rico.
`(3) In this regulation the term
`‘‘where appropriate’’ is used several
`times. When a requirement is qualified
`by ‘‘where appropriate,’’ it is deemed
`to be ‘‘appropriate’’ unless the manu-
`facturer can document justification
`otherwise. A requirement is ‘‘appro-
`priate’’ if nonimplementation could
`reasonably be expected to result in the
`product not meeting its specified re-
`quirements or the manufacturer not
`being able to carry out any necessary
`corrective action.
`(b) Limitations. The quality system
`regulation in this part supplements
`regulations in other parts of this chap-
`ter except where explicitly stated oth-
`erwise. In the event that it is impos-
`sible to comply with all applicable reg-
`ulations, both in this part and in other
`
`152
`
`VerDate Aug<04>2004 10:12 May 23, 2005 Jkt 205072 PO 00000 Frm 00162 Fmt 8010 Sfmt 8010 Y:\SGML\205072.XXX 205072
`
`JUBILANT EXHIBIT 1024
`Jubilant v. Bracco, IPR2018-01449
`
`

`

`Food and Drug Administration, HHS
`
`parts of this chapter, the regulations
`specifically applicable to the device in
`question shall supersede any other gen-
`erally applicable requirements.
`(c) Authority. Part 820 is established
`and issued under authority of sections
`501, 502, 510, 513, 514, 515, 518, 519, 520,
`522, 701, 704, 801, 803 of the act (21 U.S.C.
`351, 352, 360, 360c, 360d, 360e, 360h, 360i,
`360j, 360l, 371, 374, 381, 383). The failure
`to comply with any applicable provi-
`sion in this part renders a device adul-
`terated under section 501(h) of the act.
`Such a device, as well as any person re-
`sponsible for the failure to comply, is
`subject to regulatory action.
`(d) Foreign manufacturers. If a manu-
`facturer who offers devices for import
`into the United States refuses to per-
`mit or allow the completion of a Food
`and Drug Administration (FDA) inspec-
`tion of the foreign facility for the pur-
`pose of determining compliance with
`this part, it shall appear for purposes
`of section 801(a) of the act, that the
`methods used in, and the facilities and
`controls used for, the design, manufac-
`ture, packaging, labeling, storage, in-
`stallation, or servicing of any devices
`produced at such facility that are of-
`fered for import into the United States
`do not conform to the requirements of
`section 520(f) of the act and this part
`and that the devices manufactured at
`that facility are adulterated under sec-
`tion 501(h) of the act.
`(e) Exemptions or variances. (1) Any
`person who wishes to petition for an
`exemption or variance from any device
`quality system requirement is subject
`to the requirements of section 520(f)(2)
`of the act. Petitions for an exemption
`or variance shall be submitted accord-
`ing to the procedures set forth in § 10.30
`of this chapter, the FDA’s administra-
`tive procedures. Guidance is available
`from the Center for Devices and Radio-
`logical Health, Division of Small Man-
`ufacturers Assistance (HFZ–220), 1350
`Piccard Dr., Rockville, MD 20850,
`U.S.A., telephone 1–800–638–2041 or 1–
`301–443–6597, FAX 301–443–8818.
`(2) FDA may initiate and grant a
`variance from any device quality sys-
`tem requirement when the agency de-
`termines that such variance is in the
`best interest of the public health. Such
`variance will remain in effect only so
`long as there remains a public health
`
`§ 820.3
`
`need for the device and the device
`would not likely be made sufficiently
`available without the variance.
`
`[61 FR 52654, Oct. 7, 1996, as amended at 65 FR
`17136, Mar. 31, 2000; 65 FR 66636, Nov. 7, 2000]
`
`EFFECTIVE DATE NOTE: At 69 FR 29829, May
`25, 2004, § 820.1 was amended by adding two
`sentences to the end of paragraph (a)(1) and
`by revising paragraph (b), effective May 25,
`2005. For the convenience of the user, the
`added and revised text is set forth as follows:
`
`§ 820.1 Scope.
`(a) Applicability. (1) * * * Manufacturers of
`human cells, tissues, and cellular and tissue-
`based products (HCT/Ps), as defined in
`§ 1271.3(d) of this chapter, that are medical
`devices (subject to premarket review or noti-
`fication, or exempt from notification, under
`an application submitted under the device
`provisions of the act or under a biological
`product license application under section 351
`of the Public Health Service Act) are subject
`to this part and are also subject to the
`donor-eligibility procedures set forth in part
`1271 subpart C of this chapter and applicable
`current good tissue practice procedures in
`part 1271 subpart D of this chapter. In the
`event of a conflict between applicable regu-
`lations in part 1271 and in other parts of this
`chapter, the regulation specifically applica-
`ble to the device in question shall supersede
`the more general.
`
`*
`*
`*
`*
`*
`(b) The quality system regulation in this
`part supplements regulations in other parts
`of this chapter except where explicitly stat-
`ed otherwise. In the event of a conflict be-
`tween applicable regulations in this part and
`in other parts of this chapter, the regula-
`tions specifically applicable to the device in
`question shall supersede any other generally
`applicable requirements.
`
`*
`
`*
`
`*
`
`*
`
`*
`
`§ 820.3 Definitions.
`(a) Act means the Federal Food,
`Drug, and Cosmetic Act, as amended
`(secs. 201–903, 52 Stat. 1040 et seq., as
`amended (21 U.S.C. 321–394)). All defini-
`tions in section 201 of the act shall
`apply to the regulations in this part.
`(b) Complaint means any written,
`electronic, or oral communication that
`alleges deficiencies related to the iden-
`tity, quality, durability, reliability,
`safety, effectiveness, or performance of
`a device after it is released for dis-
`tribution.
`
`153
`
`VerDate Aug<04>2004 10:12 May 23, 2005 Jkt 205072 PO 00000 Frm 00163 Fmt 8010 Sfmt 8010 Y:\SGML\205072.XXX 205072
`
`