[Federal Register Volume 63, Number 114 (Monday, June 15, 1998)]
[Notices]
[Pages 32667-32672]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-15812]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98N-0357]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the collection of information by July 
15, 1998.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Margaret R. Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the PRA 
(44 U.S.C. 3507), FDA has submitted the following proposed collection 
of information to OMB for review and clearance.

Medical Devices; Current Good Manufacturing Practice (CGMP) Quality 
System (QS) (21 CFR Part 820)--(OMB Control Number 0910-0073--
Reinstatement)

    Under section 520(f) of the Federal Food, Drug, and Cosmetic Act 
(the act) (21 U.S.C. 360j(f)), the Secretary of the Department of 
Health and Human Services (the Secretary) has the authority to 
prescribe regulations requiring that the methods used in, and the 
facilities and controls used for, the manufacture, pre-production 
design validation (including a process to assess the performance of a 
device but not including an evaluation of the safety and effectiveness 
of a device), packing, storage, and installation of a device conform to 
CGMP, as described in such regulations, to assure that the device will 
be safe and effective and otherwise in compliance with the act.
    The CGMP/QS regulation implementing the authority provided by this 
statutory provision is found in part 820 of the Code of Federal 
Regulations (21 CFR part 820) and sets forth basic CGMP requirements 
governing the design, manufacture, packing, labeling, storage, 
installation, and servicing of all finished medical devices intended 
for human use. Section 820.20(a) through (e) requires management with 
executive responsibility to establish, maintain, and/or review: The 
quality policy; the organizational structure; the quality plan; and the 
quality system procedures of the organization. Section 820.22 requires 
the conduct and documentation of quality system audits and reaudits. 
Section 820.25(b) requires the establishment of procedures to identify 
training needs and documentation of such training.
    Section 820.30(a)(1) and (b) through (j) requires, in the following 
respective order, the establishment, maintenance, and/or documentation 
of: Procedures to control design of class III and class II devices, and 
certain class I devices as listed therein; plans for design and 
development activities and updates; procedures identifying, 
documenting, and approving design input requirements; procedures 
defining design output, including acceptance criteria, and 
documentation of approved records; procedures for formal review of 
design results and documentation of results in the design history file 
(DHF); procedures for verifying device design and documentation of 
results and approvals in the DHF; procedures for validating device 
design, including documentation of results in the DHF; procedures for 
translating device design into production specifications; procedures 
for documenting, verifying validating approved design changes before 
implementation of changes; and the records and references constituting 
the DHF for each type of device.
    Section 820.40 requires the establishment and maintenance of 
procedures for the review, approval, issuance and documentation of 
required records (documents) and changes to those records.
    Section 820.50 requires the establishment and maintenance of 
procedures and requirements to ensure service and product quality, 
records of acceptable suppliers and purchasing

[[Page 32668]]

data describing specified requirements for products and services.
    Sections 820.60 and 820.65 require, respectively, the establishment 
and maintenance of procedures for identifying all products from receipt 
to distribution and for using control numbers to track surgical 
implants and life-sustaining or supporting devices and their 
components.
    Section 820.70(a) through (e), and (g) through (i) requires the 
establishment, maintenance, and/or documentation of: Process control 
procedures; procedures for verifying or validating changes to 
specification, method, process, or procedure; procedures to control 
environmental conditions and inspection result records; requirements 
for personnel hygiene; procedures for preventing contamination of 
equipment and products; equipment adjustment, cleaning and maintenance 
schedules; equipment inspection records; equipment tolerance postings; 
procedures for utilizing manufacturing materials expected to have an 
adverse effect on product quality; and validation protocols and 
validation records for computer software and software changes.
    Sections 820.72 and 820.75(a), (b), (b)(2), and (c) require, 
respectively, the establishment, maintenance, and/or documentation of: 
Equipment calibration and inspection procedures; national, 
international or in-house calibration standards; records that identify 
calibrated equipment and next calibration dates; validation procedures 
and validation results for processes not verifiable by inspections and 
tests; procedures for keeping validated processes within specified 
limits; records for monitoring and controlling validated processes; and 
records of the results of revalidation where necessitated by process 
changes or deviations.
    Sections 820.80 and 820.86, respectively, require the 
establishment, maintenance, and/or documentation of: Procedures for 
incoming acceptance by inspection, test or other verification; 
procedures for ensuring that in-process products meet specified 
requirements and the control of product until inspection and tests are 
completed; procedures for, and records that show, incoming acceptance 
or rejection is conducted by inspections, tests or other verifications; 
procedures for, and records that show, finished devices meet acceptance 
criteria and are not distributed until device master (DMR) activities 
are completed; records in the DHR showing acceptance dates, results and 
equipment used; and the acceptance/rejection identification of products 
from receipt to installation and servicing.
    Sections 820.90 and 820.100 require, respectively, the 
establishment, maintenance and/or documentation of: Procedures for 
identifying, recording, evaluating and disposing of nonconforming 
product; procedures for reviewing and recording concessions made for, 
and disposition of, nonconforming product; procedures for reworking 
products, evaluating possible adverse rework effect and recording 
results in the DHR; procedures and requirements for corrective and 
preventive actions, including analysis, investigation, identification 
and review of data, records, causes and results; and records for all 
corrective and preventive action activities.
    Sections 820.120(b) and (d), 820.130, 820.140, 820.150, 820.160, 
and 820.170, respectively, require the establishment, maintenance, and/
or documentation of: Procedures for controlling and recording the 
storage, examination, release and use of labeling; the filing of 
labels/labeling used in the DHR; procedures for controlling product 
storage areas and receipt/dispatch authorizations; procedures 
controlling the release of products for distribution; distribution 
records that identify consignee, product, date and control numbers; and 
instructions, inspection and test procedures that are made available, 
and the recording of results for devices requiring installation.
    Sections 820.180(b) and (c), 820.181, 820.184, and 820.186 require, 
respectively, the maintenance of records: That are retained at 
prescribed site(s), made readily available and accessible to FDA and 
retained for the device's life expectancy or for 2 years; that are 
contained or referenced in a DMR consisting of device, process, quality 
assurance, packaging and labeling, and installation, maintenance, and 
servicing specifications and procedures; that are contained in DHR's, 
demonstrate the manufacture of each unit, lot or batch of product in 
conformance with DMR and regulatory requirements, and include 
manufacturing and distribution dates and quantities, acceptance 
documents, labels and labeling, and control numbers; and that are 
contained in a quality system record (QSR) consisting of references, 
documents, procedures and activities not specific to particular 
devices.
    Sections 820.198(a) through (c) and 820.200(a) and (d), 
respectively, require the establishment, maintenance and/or 
documentation of: Complaint files and procedures for receiving, 
reviewing and evaluating complaints; complaint investigation records 
identifying the device, complainant and relationship of the device to 
the incident; complaint records that are reasonably accessible to the 
manufacturing site or at prescribed sites; procedures for performing 
and verifying that device servicing requirements are met and that 
service reports involving complaints are processed as complaints; and 
service reports that record the device, service activity, and test and 
inspection data.
    Section 820.250 requires the establishment and maintenance of 
procedures to identify valid statistical techniques necessary to verify 
process and product acceptability; and sampling plans, when used, that 
are written and based on a valid statistical rationale, and procedures 
for ensuring adequate sampling methods.
    The final CGMP/QS regulation amended and revised the CGMP 
requirements for medical devices set out at part 820. The final rule 
added design and purchasing controls; modified previous critical device 
requirements; revised previous validation and other requirements; and 
harmonized device CGMP requirements with quality system specifications 
in the international standard, ISO (International Organization for 
Standardization) 9001:1994 ``Quality Systems--Model for Quality 
Assurance in Design, Development Production, Installation and 
Servicing.'' The rule does not apply to manufacturers of components or 
parts of finished devices, nor to manufacturers of human blood and 
blood components subject to 21 CFR part 606. With respect to devices 
classified in class I, design control requirements apply only to class 
I devices listed in Sec. 820.30(a)(2) of the regulation.
    The rule imposed burdens upon finished device manufacturer firms, 
which are subject to all recordkeeping requirements, and upon finished 
device contract manufacturer, specification developer, repacker and 
relabeler, and contract sterilizer firms, which are subject only to 
requirements applicable to their activities. The establishment, 
maintenance and/or documentation of procedures, records and data 
required by this final regulation will assist FDA in determining 
whether firms are in compliance with CGMP requirements, which are 
intended to ensure that devices meet their design, production, 
labeling, installation, and servicing specifications and, thus are 
safe, effective and suitable for their intended purpose. In particular, 
compliance with CGMP design control requirements should decrease the 
number of design-related device failures that have resulted

[[Page 32669]]

in deaths and serious injuries. If FDA did not impose these 
recordkeeping requirements, it anticipates that design-related device 
failures would continue to occur in the same numbers as before and 
continue to result in a significant number of device recalls and 
preventable deaths and serious injuries. Moreover, manufacturers would 
be unable to take advantage of substantial savings attributable to 
reduced recall costs, improved manufacturing efficiency, and improved 
access to international markets through compliance with CGMP 
requirements that are harmonized with international quality system 
standards.
    FDA estimates information collection burdens imposed by the 
addition, modification and revision of CGMP requirements in the final 
rule as follows:
      

[[Page 32670]]



                                                          Table 1.--Annual Recordkeeping Burden                                                         
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                Total Hours\1\                                          
                                   Number of        Annual      Total Annual     Hours per       (incremental       Total Hours\2\     Total Operating &
        21 CFR Section           Recordkeepers   Frequency of     Records      Recordkeeper       increase in      (prior continuing   Maintenance Costs
                                                Recordkeeping                                      burdens)            burdens)                         
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.20(a)                         7,237              1           7,237             10.96           79,386             -------             -------       
820.20(b)                         7,237              1           7,237              6.38           35,285              10,885            --------       
820.20(c)                         7,237              1           7,237             10.28           74,364             -------             -------       
820.20(d)                         7,237              1           7,237             16.49          119,305             -------             -------       
820.20(e)                         7,237              1           7,237             16.49          119,305             -------             -------       
820.22(a)                         7,237              1           7,237             53.53          376,507              10,885             -------       
820.25(b)                         7,237              1           7,237             21.13          152,896             -------             -------       
820.30(a)(1)                      7,237              1           7,237              2.92           21,162             -------             -------       
820.30(b)                         7,237              1           7,237              9.91           71,718             -------             -------       
820.30(c)                         7,237              1           7,237              2.92           21,162             -------             -------       
820.30(d)                         7,237              1           7,237              2.92           21,162             -------             -------       
820.30(e)                         7,237              1           7,237             38.98          282,115             -------             -------       
820.30(f)                         7,237              1           7,237             62.37          451,342             -------         $27,363,204       
820.30(g)                         7,237              1           7,237             62.37          451,342             -------             -------       
820.30(h)                         7,237              1           7,237              5.56           40,236             -------             -------       
820.30(I)                         7,237              1           7,237             28.77          208,173             -------             -------       
820.30(j)                         7,237              1           7,237              4.40           31,848             -------             -------       
820.40                            7,237              1           7,237             13.61           85,081              13,420             -------       
820.40(a) and (b)                 7,237              1           7,237              2.04          -------              14,748             -------       
820.50(a)(1) through (a)(3)       7,237              1           7,237             34.34          225,240              23,251            $898,500       
820.50(b)                         7,237              1           7,237             10.04           72,679             -------             -------       
820.60                            7,237              1           7,237              0.54            3,914             -------             -------       
820.65                            7,237              1           7,237              0.67          -------               4,839             -------       
820.70(a)(1) through (a)(5)       7,237              1           7,237              1.85          -------              13,420             -------       
820.70(b) and (c)                 7,237              1           7,237              1.85          -------              13,420             -------       
820.70(d)                         7,237              1           7,237              4.11           22,335               7,374             -------       
820.70(e)                         7,237              1           7,237              1.85          -------              13,420             -------       
820.70(g)(1) through (g)(3)       7,237              1           7,237              1.43          -------              10,347             -------       
820.70(h)                         7,237              1           7,237              1.85          -------              13,420             -------       
820.70(i)                         7,237              1           7,237             11.26           68,092              13,420             -------       
820.72(a)                         7,237              1           7,237              7.26           42,165              10,347             -------       
820.72(b)(1) through (b)(3)       7,237              1           7,237              1.43          -------              10,347             -------       
820.75(a)                         7,237              1           7,237              3.81           20,172               7,374             -------       
820.75(b)                         7,237              1           7,237              1.02          -------               7,374             -------       
820.75(b)(2)                      7,237              1           7,237              1.17            1,096               7,374             -------       
820.75(c)                         7,237              1           7,237              1.17            1,096               7,374             -------       
820.80(a) through (e)             7,237              1           7,237              4.80          -------              34,721             -------       
820.86                            7,237              1           7,237              0.79          -------               5,735            --------       
820.90(a)                         7,237              1           7,237              7.39           44,217               9,272             -------       
820.90(b)(1) and (b)(2)           7,237              1           7,237              7.39           44,217               9,272             -------       
820.100(a)(1) through (a)(7)      7,237              1           7,237             20.50          145,144               3,226             -------       
820.100(b)                        7,237              1           7,237              1.28          -------               9,272             -------       
820.120                           7,237              1           7,237              0.45          -------               3,226             -------       
820.120(b)                        7,237              1           7,237              0.45          -------               3,226             -------       
820.120(d)                        7,237              1           7,237              0.45          -------               3,226             -------       
820.130                           7,237              1           7,237              0.45          -------               3,226             -------       
820.140                           7,237              1           7,237             10.12           68,418               4,839             -------       
820.150(a) and (b)                7,237              1           7,237              9.45           68,418             -------             -------       
820.160(a) and (b)                7,237              1           7,237              0.67          -------               4,839             -------       
820.170(a) and (b)                7,237              1           7,237              1.50          -------              10,885             -------       
820.180(b) and (c)                7,237              1           7,237              1.50          -------              10,885             -------       
820.181(a) through (e)            7,237              1           7,237              1.21          -------               8,783             -------       
820.184(a) through (f)            7,237              1           7,237              1.41          -------              10,240             -------       

[[Page 32671]]

                                                                                                                                                        
820.186                           7,237              1           7,237              0.40          -------               2,873             -------       
820.198(a) through (c)            7,237              1           7,237              6.42           26,850              19,644             -------       
820.200(a) through (d)            7,237              1           7,237              4.35           31,459             -------             -------       
820.250                           7,237              1           7,237              0.67          -------               4,839             -------       
Totals                            7,237              1           7,237                          3,527,901             375,268         $28,261,704       
Grand Totals\3\                                                                                                     3,903,169         $28,261,704       
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Incremental increase in burden hours to achieve compliance with additional requirements in revised regulation.                                      
\2\ Recordkeeping hours for prior requirements carried over into revised regulation, as approved by OMB on July 16, 1992, and expired on June 30, 1995  
  (OMB No. 0910-0073).                                                                                                                                  
\3\ Note: Totals may not add due to rounding.                                                                                                           


[[Page 32672]]

Under OMB information collection 0910-0073, Current Good Manufacturing 
Practices (CGMP) for Medical Devices, there were 375,266 hours approved 
for recordkeeping information collections contained in part 820. These 
hours included 114,882 burden hours as a one time start up expenditure 
for 650 new firms. The additional requirements contained in Current 
Good Manufacturing Practice; Quality system (CGMP/QS) regulation will 
add 3,527,901 burden hours to the burden, resulting in a total 
recordkeeping burden of 3,903,169 hours. The 3,527,901 burden hours 
includes 1,433,579 burden hours for a one time start up expenditure for 
7,237 manufacturers and 2,094,321 burden hours expended annually by 
7,237 manufacturers.
    The recordkeeping estimate includes approximately 9.6 times as many 
manufacturers with a one time start up expenditure, due to the addition 
of the design control requirements. Further, the recordkeeping burden 
hour calculations were estimated using a complex methodology involving 
the estimated noncompliance ratio for small, medium, large, and very 
large manufacturers multiplied by the number of manufacturers in each 
category. These calculations factor in a rate of product innovation for 
new products, including 510(k) devices.
    Approximately 85 percent of the additional burden hours for CGMP/QS 
regulation originate from the following four subparts of part 820: (1) 
Subpart B--Quality System Requirements; (2) Subpart C--Design controls; 
(3) Subpart E--Purchasing Controls; and (4) Subpart J--Corrective and 
Preventive Action. Over 45 percent of the 3,527,901 burden hours are 
attributed directly to the addition of design control requirements. The 
purchasing control requirements and the respective recordkeeping burden 
are approximately 8 percent of the additional recordkeeping burden.

    Dated: June 8, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-15812 Filed 6-12-98; 8:45 am]
BILLING CODE 4160-01-F