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`Federal Register / Vol. 61, No. 195 / Monday, October 7, 1996 / Rules and Regulations
`
`DEPARTMENT OF HEALTH AND
`HUMAN SERVICES
`Food and Drug Administration
`21 CFR Parts 808, 812, and 820
`[Docket No. 90N–0172]
`RIN 0910–AA09
`Medical Devices; Current Good
`Manufacturing Practice (CGMP) Final
`Rule; Quality System Regulation
`AGENCY: Food and Drug Administration,
`HHS.
`ACTION: Final rule.
`SUMMARY: The Food and Drug
`Administration (FDA) is revising the
`current good manufacturing practice
`(CGMP) requirements for medical
`devices and incorporating them into a
`quality system regulation. The quality
`system regulation includes requirements
`related to the methods used in, and the
`facilities and controls used for,
`designing, manufacturing, packaging,
`labeling, storing, installing, and
`servicing of medical devices intended
`for human use. This action is necessary
`to add preproduction design controls
`and to achieve consistency with quality
`system requirements worldwide. This
`regulation sets forth the framework for
`device manufacturers to follow and
`gives them greater flexibility in
`achieving quality requirements.
`DATES: The regulation is effective June
`1, 1997. For more information on
`compliance with 21 CFR 820.30 see
`section IV. of this document.
`Written comments on the information
`collection requirements should be
`submitted by December 6, 1996.
`ADDRESSES: Submit written comments
`on the information collection
`requirements to the Dockets
`Management Branch (HFA–305), Food
`and Drug Administration, 12420
`Parklawn Dr., rm. 1–23, Rockville, MD
`20857. All comments should be
`identified with the docket number
`found in brackets in the heading of this
`document.
`FOR FURTHER INFORMATION CONTACT:
`Kimberly A. Trautman, Center for
`Devices and Radiological Health (HFZ-
`341), Food and Drug Administration,
`2098 Gaither Rd., Rockville, MD 20850,
`301–594–4648.
`SUPPLEMENTARY INFORMATION:
`I. Background
`Manufacturers establish and follow
`quality systems to help ensure that their
`products consistently meet applicable
`requirements and specifications. The
`quality systems for FDA-regulated
`
`products (food, drugs, biologics, and
`devices) are known as CGMP’s. CGMP
`requirements for devices in part 820 (21
`CFR part 820) were first authorized by
`section 520(f) of the Federal Food, Drug,
`and Cosmetic Act (the act) (21 U.S.C.
`360j(f)), which was among the
`authorities added to the act by the
`Medical Device Amendments of 1976
`(Pub. L. 94–295).
`Under section 520(f) of the act, FDA
`issued a final rule in the Federal
`Register of July 21, 1978 (43 FR 31 508),
`prescribing CGMP requirements for the
`methods used in, and the facilities and
`controls used for the manufacture,
`packing, storage, and installation of
`medical devices. This regulation became
`effective on December 18, 1978, and is
`codified under part 820. Except for
`editorial changes to update
`organizational references in the
`regulation and revisions to the list of
`critical devices that was included in the
`preamble to the final regulation, the
`device CGMP requirements have not
`been revised since 1978. This final rule
`is the result of an extensive effort begun
`in 1990 to revise this regulation.
`The Safe Medical Devices Act of 1990
`(the SMDA) (Pub. L. 101–629), enacted
`on November 28, 1990, amended section
`520(f) of the act, providing FDA with
`the authority to add preproduction
`design controls to the CGMP regulation.
`This change in law was based on
`findings that a significant proportion of
`device recalls were attributed to faulty
`design of product. Specifically, in
`January 1990, FDA published the results
`of an evaluation of device recalls that
`occurred from October 1983 through
`September 1989, in a report entitled
`‘‘Device Recalls: A Study of Quality
`Problems’’ (Ref. 1). (See 55 FR 21108,
`May 22, 1990, where FDA announced
`the availability of the report.) FDA
`found that approximately 44 percent of
`the quality problems that led to
`voluntary recall actions during this 6-
`year period were attributed to errors or
`deficiencies that were designed into
`particular devices and may have been
`prevented by adequate design controls.
`These design-related defects involved
`both noncritical devices (e.g., patient
`chair lifts, in vitro diagnostics, and
`administration sets) and critical devices
`(e.g., pacemakers and ventilators). Also
`in 1990, the Department of Health and
`Human Services’ Inspector General
`conducted a study entitled ‘‘FDA
`Medical Device Regulation From
`Premarket Review to Recall’’ (Ref. 2),
`which reached similar conclusions.
`With respect to software used to operate
`medical devices, the data were even
`more striking. A subsequent study of
`software-related recalls for the period of
`
`fiscal year (FY) 1983 through FY 1991
`indicated that over 90 percent of all
`software-related device failures were
`due to design-related errors, generally,
`the failure to validate software prior to
`routine production (Ref. 3).
`The SMDA also added new section
`803 to the act (21 U.S.C. 383) which,
`among other things, encourages FDA to
`work with foreign countries toward
`mutual recognition of CGMP
`requirements. FDA undertook the
`revision of the CGMP regulation to add
`the design controls authorized by the
`SMDA to the CGMP regulation, as well
`as because the agency believed that it
`would be beneficial to the public and
`the medical device industry for the
`CGMP regulation to be consistent, to the
`extent possible, with the requirements
`for quality systems contained in
`applicable international standards,
`primarily, the International
`Organization for Standards (ISO)
`9001:1994 ‘‘Quality Systems—Model for
`Quality Assurance in Design,
`Development, Production, Installation,
`and Servicing’’ (Ref. 4), and the ISO
`committee draft (CD) revision of ISO/CD
`13485 ‘‘Quality Systems—Medical
`Devices—Supplementary Requirements
`to ISO 9001’’ (Ref. 5).
`This action is being taken under those
`provisions of the SMDA and in response
`to the following: (1) Notices that
`appeared in the Federal Register of
`April 25, 1990 (55 FR 17502), and in the
`Federal Register of April 17, 1991 (56
`FR 15626), that announced meetings of
`the agency’s Device Good
`Manufacturing Practice Advisory
`Committee (GMP Advisory Committee),
`at which the need for revisions to the
`CGMP regulation was explored; (2) an
`advance notice of proposed rulemaking
`(ANPRM) that appeared in the Federal
`Register of June 15, 1990 (55 FR 24544),
`that announced the agency’s intent to
`revise the CGMP regulation; (3) a notice
`of availability of a document that
`appeared in the Federal Register of
`November 30, 1990 (55 FR 49644),
`entitled ‘‘Medical Devices; Current
`Good Manufacturing Practices (CGMP)
`Regulations Document; Suggested
`Changes; Availability’’ (Ref. 6) and
`comments solicited from the public
`about the document; (4) a proposed rule
`in the Federal Register of November 23,
`1993 (58 FR 61952), (Ref. 7) and
`comments solicited from the public
`about the proposal; (5) a notice of
`availability that appeared in the Federal
`Register of July 24, 1995 (60 FR 37856),
`announcing the availability of the
`‘‘Working Draft of the Current Good
`Manufacturing Practice (CGMP) Final
`Rule’’ (hereinafter referred to as the
`Working Draft) (Ref. 8) and comments
`
`Page 1
`
`
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`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
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`Medtronic Ex.1772
`Medtronic v. Teleflex
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`Federal Register / Vol. 61, No. 195 / Monday, October 7, 1996 / Rules and Regulations
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`solicited from the public about the
`Working Draft; (6) testimony at an
`August 23, 1995, open public meeting
`announced in the Federal Register (60
`FR 37856); (7) and testimony and
`advisory committee recommendations
`from the September 13 and 14, 1995,
`meeting of the GMP Advisory
`Committee announced in the Federal
`Register of August 24, 1995 (60 FR
`44036). Thus, FDA’s decision to revise
`the CGMP regulation is based on
`changes in the law made by the SMDA,
`the agency’s discussions with others
`including its GMP Advisory Committee,
`responses to the Federal Register
`notices on this matter, FDA’s analysis of
`recall data, its experience with the
`regulatory application of the original
`CGMP regulation, and its assessment of
`international quality standards.
`The agency’s final rule embraces the
`same ‘‘umbrella’’ approach to the CGMP
`regulation that is the underpinning of
`the original CGMP regulation. Because
`this regulation must apply to so many
`different types of devices, the regulation
`does not prescribe in detail how a
`manufacturer must produce a specific
`device. Rather, the regulation provides
`the framework that all manufacturers
`must follow by requiring that
`manufacturers develop and follow
`procedures and fill in the details that
`are appropriate to a given device
`according to the current state-of-the-art
`manufacturing for that specific device.
`FDA has made changes to the proposed
`regulation and the Working Draft, as the
`final rule evidences, to provide
`manufacturers with even greater
`flexibility in achieving the quality
`requirements.
`The Supreme Court recently
`addressed the preemptive effect, under
`section 521 of the act (21 U.S.C. 360k),
`of the original CGMP regulation and
`other FDA requirements for medical
`devices on State tort actions. In
`Medtronic, Inc. v. Lohr, 116 S. Ct. 2240
`(1996), the Supreme Court gave
`substantial deference to the agency’s
`interpretation of section 521 of the act
`found at § 808.1 (21 CFR 808.1). The
`Court noted that CGMP requirements
`are general rather than ‘‘specific
`requirements applicable to a particular
`device,’’ and that State common law
`remedies are similarly general, and do
`not establish a ‘‘substantive requirement
`for a specific device.’’ (Lohr at 2257; see
`also § 808.1(d) and (d)(6)(ii).) Moreover,
`the Court drew a distinction between
`remedies and requirements, noting that
`while common law tort actions may
`provide remedies different from those
`available under the act, no preemption
`occurs unless the substantive
`requirements of the State law are
`
`‘‘different from, or in addition to,’’ those
`imposed by the act. (See Lohr at 2255.)
`Under the Supreme Court’s analysis in
`Lohr, the requirements imposed by the
`original CGMP regulation would rarely
`have preemptive effect.
`FDA believes that the reasoning of
`Medtronic v. Lohr applies equally to the
`new quality system regulation, which,
`as does the original CGMP regulation,
`prescribes requirements that apply to
`medical devices in general, rather than
`to any particular medical device.
`Therefore, FDA has concurrently
`amended part 808 (21 CFR part 808) to
`make clear the new quality system
`regulation does not preempt State tort
`and common law remedies.
`II. Decision to Make a Working Draft
`Available for Comment
`In the Federal Register of November
`23, 1993, the agency issued the
`proposed revisions to the CGMP
`regulation, entitled ‘‘Medical Devices;
`Current Good Manufacturing Practice
`(CGMP) Regulations; Proposed
`Revisions; Request for Comments,’’ and
`public comment was solicited. After the
`proposal issued, FDA met with the
`Global Harmonization Task Force (the
`GHTF) Study Group in early March
`1994, in Brussels, to compare the
`provisions of the proposal with the
`provisions of ISO 9001:1994 and
`European National Standard (EN) 46001
`‘‘Quality Systems—Medical Devices—
`Particular Requirements for the
`Application of EN 29001’’ (Ref. 9). ISO
`9001:1994 and EN 46001:1994 are
`written as voluntary standards, but
`when used to fulfill the requirements of
`the European Medical Device Directives,
`or other national regulations, these
`standards are mandatory requirements
`similar to the CGMP requirements. The
`GHTF includes: Representatives of the
`Canadian Ministry of Health and
`Welfare, the Japanese Ministry of Health
`and Welfare, FDA, and industry
`members from the European Union
`(EU), Australia, Canada, Japan, and the
`United States. The participants at the
`GHTF meeting favorably regarded FDA’s
`effort toward harmonization with
`international standards. The GHTF
`submitted comments, however, noting
`where FDA could more closely
`harmonize to achieve consistency with
`quality system requirements worldwide.
`Since the proposal published, FDA has
`also attended numerous industry and
`professional association seminars and
`workshops, including ISO Technical
`Committee (TC) 210 ‘‘Quality
`Management and Corresponding
`General Aspects for Medical Devices’’
`meetings, where the proposed revisions
`were discussed.
`
`The original period for comment on
`the proposal closed on February 22,
`1994, and was extended until April 4,
`1994. Because of the heavy volume of
`comments and the desire to increase
`public participation in the development
`of the quality system regulation, FDA
`decided to publish the notice of
`availability in the Federal Register to
`allow comment on the Working Draft
`before issuing a final regulation.
`The Working Draft represented the
`agency’s views at the time on how it
`would respond to the many comments
`received, and on how the agency
`believed a final rule should be framed.
`FDA solicited public comment on the
`Working Draft until October 23, 1995, to
`determine if the agency had adequately
`addressed the many comments received
`and whether the agency had framed a
`final rule that achieved the public
`health goals to be gained from
`implementation of quality systems in
`the most efficient manner.
`III. Open Public Meeting and GMP
`Advisory Committee Meeting
`FDA held an open public meeting on
`the quality system regulation on August
`23, 1995. The public meeting consisted
`of prepared presentations followed by
`an open discussion period. Both the
`agency and the participants found the
`meeting to be very productive in
`focusing attention on the few main areas
`of concern in the Working Draft. The
`main issues were: The application of the
`regulation to component manufacturers;
`the application of the regulation to third
`party servicers and refurbishers; and the
`implementation timeframe of the final
`rule. A transcript of the proceedings of
`the public meeting, as well as data and
`information submitted to FDA during
`the public meeting, are available from
`the Dockets Management Branch (HFA–
`305), Food and Drug Administration,
`12420 Parklawn Dr., rm. 1–23,
`Rockville, MD 20857, between 9 a.m.
`and 4 p.m., Monday through Friday.
`There also was a meeting of the GMP
`Advisory Committee on the Working
`Draft on September 13 and 14, 1995. A
`notice of the meeting was published in
`the Federal Register of August 24, 1995.
`FDA made a brief presentation to the
`committee on the changes from the 1993
`proposal to the 1995 Working Draft and
`discussed some changes that FDA was
`recommending as a result of the August
`1995 meeting. Two consultants also
`made presentations to the committee,
`one a representative from ISO TC 176
`(the TC that authored the ISO 9000
`series) and the other a representative
`from the European Committee for
`Standardization (CEN). The remainder
`of the meeting consisted of prepared
`
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`presentations from the public and the
`committee’s discussion on the main
`issues.
`The overwhelming majority of the
`committee members believed that the
`Working Draft met the public health
`needs, gave manufacturers sufficient
`flexibility to comply with the
`regulation, and met the agency’s goal of
`harmonizing the quality system
`requirements with those of other
`countries. The GMP Advisory
`Committee strongly supported FDA’s
`recommendation, in response to the
`August 1995 public meeting, to not
`include component manufacturers
`under this final rule. However, the GMP
`Advisory Committee was clearly
`divided on several issues related to the
`proposed regulation of third party
`servicers and refurbishers. A transcript
`of the proceedings of the GMP Advisory
`Committee meeting, as well as data and
`information submitted to FDA during
`the meeting, are available from the
`Dockets Management Branch (address
`above).
`After considering the written
`comments and the views expressed at
`meetings with the GHTF, at the August
`1995 public meeting, and at the
`September 1995 GMP Advisory
`Committee meeting, FDA is publishing
`this final rule. A summary of changes
`from the July 1995 Working Draft to the
`final rule is contained at the end of this
`preamble.
`IV. Implementation of the Final Rule
`FDA has decided, in response to the
`many comments and concerns
`expressed about the need for more time
`to implement design controls, to
`implement the final rule in two stages.
`Under stage one, on June 1, 1997,
`approximately 1 year after this rule is
`published in the Federal Register, all
`elements of the final rule become
`effective. However, with respect to the
`design control requirements in § 820.30,
`as long as manufacturers are taking
`reasonable steps to come into
`compliance, FDA will implement a
`special 1-year transition program, with
`a midcourse review, during which
`official agency action will not be
`initiated, including FDA Form 483
`observations, warning letters, or
`enforcement cases, based on failure to
`comply with § 820.30. Under stage two,
`beginning June 1, 1998, FDA will treat
`noncompliance with design control
`requirements in § 820.30 the same as
`noncompliance with other provisions of
`the CGMP regulation.
`To prepare for stage one of this
`implementation plan, FDA intends to
`develop, by April of 1997, a strategy for
`inspecting the design control
`
`requirements. Both industry and FDA
`field investigators will then be trained
`on this inspectional strategy for design
`controls during April and May 1997.
`Starting June 1, 1997, manufacturers
`will be inspected for compliance with
`all the new quality system requirements,
`including design controls, in the
`manner described in the inspectional
`strategy. However, as part of the
`transition program, from June 1, 1997,
`for a period of 1 year, although FDA will
`inspect firms for compliance with the
`design control requirements, the field
`will issue any observations to the
`manufacturer on a separate design
`control inspectional strategy report, not
`on FDA Form 483. The design control
`inspectional strategy report will be
`made a part of the manufacturer’s
`establishment inspection report (EIR),
`but the observations relating to § 820.30
`will not be included in any warning
`letters or regulatory actions during this
`initial 1-year period. FDA notes that it
`can, at any time, take action against
`unsafe or adulterated medical devices
`under different regulatory or statutory
`authorities. FDA wants to emphasize
`that manufacturers are required to take
`reasonable steps to come into
`compliance with the design control
`requirements during the June 1, 1997, to
`June 1, 1998, period.
`FDA also emphasizes that this
`transition period relates only to the
`design control requirements of § 820.30,
`and that beginning June 1, 1997, the
`agency will issue observations on FDA
`Form 483’s, issue warning letters, and
`take any necessary regulatory action for
`violations of all other provisions of the
`CGMP final rule. The time period from
`June 1, 1997, to June 1, 1998, is
`intended to allow both the industry and
`FDA field investigators time to become
`familiar with the design control
`requirements and the enforcement
`aspects of this new area.
`Finally, as described elsewhere in this
`preamble, FDA intends to conduct a
`midcourse review of the new design
`control requirements during the
`transition year (June 1997 to June 1998).
`Specifically, the results of the first
`several months of design control
`inspections will be reviewed by early
`1998. FDA will review all of the
`completed design control inspectional
`strategy reports that were given to
`manufacturers from between June 1,
`1997, through December 1, 1997. The
`completed strategy reports will be
`reviewed with particular attention paid
`to clarity of information obtained, the
`appropriateness of the information
`collected with respect to the design
`control requirements, the
`appropriateness of the questions on the
`
`inspectional strategy, the manner in
`which the investigators are writing out
`their observations, and any
`requirements that seem to be giving
`manufacturers a problem or where there
`might be misunderstandings as to what
`the regulation requires. FDA will then
`hold an open public meeting in early
`1998 to discuss with industry these
`findings and to further explore any
`concerns industry might be having in
`implementing the new design control
`requirements. As a result of the
`midcourse review and open public
`meeting, FDA might hold additional
`workshops, meetings, and/or training
`sessions.
`Any midcourse adjustments to the
`inspectional strategy will be instituted
`and made public by the spring of 1998.
`Also during this midcourse review, FDA
`will evaluate the information gathered
`at that point and determine if the design
`control requirements as written in this
`final rule are appropriate to obtain the
`goals expressed in this preamble. FDA
`will consider minor or even major
`changes, based on experience to date.
`Any necessary adjustments or proposed
`revisions will be published in the
`Federal Register and comments will be
`solicited as necessary during the spring
`of 1998. This implementation strategy is
`responsive to requests by industry for
`FDA to harmonize the quality system
`regulation’s implementation with the
`mandatory date for implementation of
`the EU’s Medical Device Directive,
`which is June 1998. However, if during
`the midcourse review of stage one it is
`determined that the industry and/or
`FDA needs more time to fully
`implement the design control
`requirements, FDA will publish an
`extension of the regulatory
`implementation date for design control
`requirements prior to June 1, 1998.
`V. Response to Comments and
`Rationale for Changes
`Approximately 280 separate
`individuals or groups commented on
`the proposal published in the Federal
`Register of November 23, 1993, and
`approximately 175 separate individuals
`or groups commented on the Working
`Draft that was announced in a notice of
`availability published in the Federal
`Register on July 24, 1995. FDA made
`many changes in response to the
`comments. Most of the changes were
`made in response to specific comments,
`in response to comments for clarity,
`understanding, and readability, or to
`further harmonize FDA requirements
`with international standards, as many
`comments requested.
`Numerous comments stated that
`industry was very pleased with FDA’s
`
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`Working Draft and the effort that was
`made to harmonize with ISO, as well as
`to engage industry in commenting on
`the Working Draft through the open
`public meeting and the GMP Advisory
`Committee meeting that were held in
`August and September 1995,
`respectively.
`FDA’s responses to the comments
`received on the proposal and the
`Working Draft, as well as explanations
`for the changes made, follow.
`A. General Provisions (Subpart A)
`i. Scope (§ 820.1)
`1. The title of the regulation, as
`reflected in this section, has been
`changed from the ‘‘Current Good
`Manufacturing Practices (CGMP)’’
`regulation to the ‘‘Quality System’’
`regulation. This revision follows the
`suggestion underlying many comments
`on specific provisions that FDA
`generally harmonize the CGMP
`requirements and terminology with
`international standards. ISO 9001:1994,
`ISO/CD 13485, and EN 46001 employ
`this terminology to describe the CGMP
`requirements. In addition, this title
`accurately describes the sum of the
`requirements, which now include the
`CGMP requirements for design,
`purchasing, and servicing controls.
`CGMP requirements now cover a full
`quality system.
`FDA notes that the principles
`embodied in this quality system
`regulation have been accepted
`worldwide as a means of ensuring that
`acceptable products are produced.
`While the regulation has been
`harmonized with the medical device
`requirements in Europe, Australia, and
`Japan, as well as the requirements
`proposed by Canada, it is anticipated
`that other countries will adopt similar
`requirements in the near future.
`FDA, however, did not adopt ISO
`9001:1994 verbatim for two reasons.
`First, there were complications in
`dealing with the issue of copyrights and,
`second, FDA along with health agencies
`of other governments does not believe
`that for medical devices ISO 9001:1994
`alone is sufficient to adequately protect
`the public health. Therefore, FDA has
`worked closely with the GHTF and TC
`210 to develop a regulation which is
`consistent with both ISO 9001:1994 and
`ISO/CD 13485. FDA made several
`suggestions to TC 210 on the drafts of
`the ISO/CD 13485 document in order to
`minimize differences and move closer to
`harmonization. In some cases, FDA has
`explicitly stated requirements that many
`experts believe are inherent in ISO
`9001:1994. Through the many years of
`experience enforcing and evaluating
`
`compliance with the original CGMP
`regulation, FDA has found that it is
`necessary to clearly spell out its
`expectations. This difference in
`approach does not represent any
`fundamentally different requirements
`that would hinder global harmonization.
`In fact, numerous comments expressed
`their approval and satisfaction with
`FDA’s effort to harmonize the quality
`system requirements with those of ISO
`9001:1994 and ISO/CD 13485.
`2. One comment suggested that the
`term ‘‘purchasing’’ in the scope be
`deleted because it could be interpreted
`to mean the purchase of finished
`medical devices by health care
`institutions and medical professionals,
`instead of the purchase of components
`and manufacturing materials as
`intended.
`FDA agrees and has deleted the term
`‘‘purchasing’’ throughout the regulation
`when used in this context.
`3. Several comments suggested that
`§ 820.1(a)(1) should not state that the
`regulation establishes the ‘‘minimum’’
`requirements because it implies that
`compliance with the stated
`requirements may be insufficient. They
`asked that FDA delete the word
`‘‘minimum,’’ to avoid having auditors
`search for additional requirements.
`FDA does not believe that the
`provision would have required that
`manufacturers meet additional
`requirements not mandated by the
`regulation but has modified the section
`to clarify its intent by stating that the
`regulation establishes the ‘‘basic’’
`requirements for manufacturing devices.
`The quality system regulation provides
`a framework of basic requirements for
`each manufacturer to use in establishing
`a quality system appropriate to the
`devices designed and manufactured and
`the manufacturing processes employed.
`Manufacturers must adopt current and
`effective methods and procedures for
`each device they design and
`manufacture to comply with and
`implement the basic requirements. The
`regulation provides the flexibility
`necessary to allow manufacturers to
`adopt advances in technology, as well as
`new manufacturing and quality system
`procedures, as they become available.
`During inspections, FDA will assess
`whether a manufacturer has established
`procedures and followed requirements
`that are appropriate to a given device
`under the current state-of-the-art
`manufacturing for that specific device.
`FDA investigators receive extensive
`training to ensure uniform
`interpretation and application of the
`regulation to the medical device
`industry. Thus, the agency does not
`believe that FDA investigators will cite
`
`deviations from requirements not
`contained in this part. However, as
`noted above, FDA has altered the
`language of the scope to make clear that
`additional, unstated requirements do
`not exist.
`4. A few comments suggested
`eliminating the distinction between
`critical and noncritical devices, thus
`eliminating the need for distinct
`requirements for critical devices. Other
`comments disagreed, asserting that
`eliminating the distinction would
`increase the cost of production of low-
`risk devices without improving their
`safety and effectiveness.
`FDA agrees in part with the comments
`that suggest eliminating the distinction
`between critical and noncritical devices
`and has eliminated the term ‘‘critical
`device’’ from the scope, definitions, and
`regulation in §§ 820.65 Critical devices,
`traceability and 820.165 Critical
`devices, labeling. However, FDA has
`retained the concept of distinguishing
`between devices for the traceability
`requirements in § 820.65. As addressed
`in the discussion under that section,
`FDA believes that it is imperative that
`manufacturers be able to trace, by
`control number, any device, or where
`appropriate component of a device, that
`is intended for surgical implant into the
`body or to support or sustain life whose
`failure to perform when properly used
`in accordance with instructions for use
`provided in the labeling can be
`reasonably expected to result in a
`significant injury to the user.
`The deletion of the terminology will
`bring the regulation in closer harmony
`with ISO 9001:1994 and the quality
`system standards or requirements of
`other countries.
`Finally, FDA notes that eliminating
`the term ‘‘critical device’’ and the list of
`critical devices does not result in the
`imposition of new requirements. In fact
`the new regulation is less prescriptive
`and gives the manufacturer the
`flexibility to determine the controls that
`are necessary commensurate with risk.
`The burden is on the manufacturer,
`however, to describe the types and
`degree of controls and how those
`controls were decided upon. Such
`determinations are made in accordance
`with standard operating procedures
`(SOP’s) established by the manufacturer.
`5. In response to numerous
`comments, FDA has added the sentence
`‘‘If a person engages in only some
`operations subject to the requirements
`in this part, and not in others, that
`person need only comply with those
`requirements applicable to the
`operations in which he or she is
`engaged.’’ This sentence was added to
`clarify the scope of the regulation and
`
`Page 4
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`
`the responsibility of those who fall
`under this regulation. The wording is
`the same as that used in the drug CGMP.
`6. Several comments recommended
`that the short list of class I devices
`subject to design control requirements
`be deleted from the regulation and be
`placed in the preamble, to allow
`additions or deletions without requiring
`a change to the entire regulation. Others
`commented that the list of class I
`devices should be entirely eliminated to
`harmonize with Europe and Japan.
`FDA disagrees that the list of devices
`subject to design control requirements
`should be deleted from the regulation.
`FDA has experienced problems or has
`concerns with the class I devices listed
`and has determined that design controls
`are needed for the listed devices.
`Further, placing the list in the
`regulation establishes the requirements
`related to those devices, and is
`convenient for use by persons who are
`not familiar with, or who do not have
`access to, the preamble. Further, FDA
`notes that individual sections of a
`regulation may be revised independent
`of the remainder of the regulation.
`7. Numerous written comments and
`persons who testified at the August and
`September 1995 meetings stated that
`application of the regulation to
`component manufacturers would
`increase product cost, with questionable
`value added to device safety and
`effectiveness, and that many component
`suppliers would refuse to supply
`components or services to the medical
`device industry. This would be
`especially likely to occur, it was
`suggested, where medical device
`manufacturers account for a small
`fraction of the supplier’s sales.
`FDA believes that because of the
`complexity of many components used
`in medical devices, their adequacy
`cannot always be assured through
`inspection and testing at the finished
`device manufacturer. This is especially
`true of software and software-related
`components, such as microprocessors
`and microcircuits. Quality must be
`designed and built into components
`through the application of proper
`quality systems.
`However, FDA notes that the quality
`system regulation now explicitly
`requires that the finished device
`manufacturer assess the capability of
`suppliers, contractors, and consultants
`to provide quality products pursuant to
`§ 820.50 Purchasing controls. These
`requirements supplement the
`acceptance requirements under
`§ 820.80. Manufacturers must comply
`with both sections for any incoming
`component or subassembly or service,
`regardless of the finished device
`
`manufacturer’s financial or business
`affiliation with the person providing
`such products or services. FDA believes
`that these purchasing controls are
`sufficient to provide the needed
`assurance that suppliers, contractors,
`and consultants have adequate controls
`to produce acceptable components.
`Therefore, balancing the many
`concerns of the medical device industry
`and the agency’s public health and
`safety concerns, FDA has decided to
`remove the provision making the CGMP
`regulation applicable to component
`manufacturers and return to the
`language in the original CGMP
`regu