[Federal Register Volume 66, Number 3 (Thursday, January 4, 2001)]
[Notices]
[Pages 800-801]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-141]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1678]


Expansion of Medical Device Industry Initiatives

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing some 
changes in its standard practices for medical device, drug, food, and 
biologics inspections based on the outcome of the expansion of the 
medical device industry initiatives pilot program. FDA is discontinuing 
the practice of post-inspection notification letters for all 
inspections because the agency now provides inspected establishments 
with a copy of the establishment inspection report (EIR) when the 
inspection is deemed closed. FDA has decided to maintain pre-announced 
inspections and annotations of the inspectional observations (FDA 483) 
as standard practices for medical device inspections but with respect 
to inspections of other program areas, to apply these initiatives at 
the discretion of district management.

DATES: The changes to the medical device and expansion programs are 
effective January 1, 2001, with the publication of FDA's 2001 edition 
of the Investigations Operations Manual (IOM). Written comments may be 
submitted at any time in accordance with FDA's good guidance practices.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Denise D. Dion, Office of Regulatory 
Affairs (HFC-130), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-5645, FAX 301-443-6919.

SUPPLEMENTARY INFORMATION: During the FDA/medical device industry 
grassroots forums in 1995, several issues were discussed concerning 
FDA's interaction with the medical device industry. A decision was made 
to consider action on three of the inspectional issues discussed. These 
included instituting: (1) Pre-announced inspections, (2) listing 
promised or completed corrective actions on FDA 483 items, and (3) 
post-inspection notification to establishments regarding their 
compliance status.
    In fiscal year (FY) 1996, FDA initiated a pilot program for the 
medical device industry, implementing these three changes. The pilot 
program took place during the 1996 calendar year and was limited to 
inspections of medical device manufacturers that did not manufacture 
products that crossed other program areas such as drugs or biologics. 
Pre-announced inspections were offered to those medical device firms 
that met the criteria for inclusion in the pilot program. The criteria 
included nonviolative current good manufacturing practices inspectional 
histories and a history that records and individuals were available at 
earlier pre-announced inspections. FDA 483 annotations and the post-
inspection notification were done for all medical device inspections 
whether or not the inspection was pre-announced.
    Based on industry input, FDA initiated another year-long pilot 
program in January 1999, to provide similar coverage for program areas 
including drugs (both human and animal) and biologics. Food inspections 
were limited to FDA 483 annotations and post-inspection notification. 
In FY 2000, FDA considered the impact of the second pilot's effects on 
field operations. The intent of the medical device pilot program was to 
optimize resource utilization, enhance FDA/industry communications, and 
provide firms prompt closure for nonviolative inspections and for 
corrected inspection observations. However, FDA determined that the 
additional burdens placed on field staff by the expansion into other 
program areas failed to capitalize resources and reduced overall field 
inspectional productivity.
    FDA believes that the new inspection method for medical device 
firms (the quality system inspection technique) implemented in October 
1999 provides

[[Page 801]]

a clear direction in the inspection of these establishments, and 
provides logical stopping points, thus making the time it takes to 
complete an inspection more predictable. FDA concludes that pre-
announcement of medical device inspections will remain standard 
procedure based on the defined criteria. For other establishments, pre-
announcement of inspections remains voluntary at the discretion of the 
local FDA office. FDA will continue generally not to pre-announce 
inspections of food, blood bank, and plasmapheresis centers, but this, 
too, will be left to the district's discretion.
    FDA investigators traditionally have discussed their observations 
with appropriate management at the establishment at the conclusion of 
the inspection. These discussions are reported in the Establishment 
Inspection Report. FDA will continue that practice, and will rely on 
the discretion of the investigator/team to determine whether to 
annotate the FDA 483. Since the medical device industry specifically 
asked FDA for annotations of the FDA 483, and since FDA has not found 
this practice to adversely affect the inspection process for medical 
devices, annotations will remain standard procedure for medical device 
inspections only.
    In April 1997, FDA implemented a Field Management Directive (FMD 
145) that requires FDA field offices to provide a copy of the EIR to 
the inspected establishment once the inspection is deemed closed. The 
copy of the EIR is provided along with a letter referred to as the 
``FMD 145 letter.'' FDA has found that the issuance of both a post-
inspection notification (PIN) letter and a FMD 145 letter is redundant. 
Because of this redundancy and the burden this puts on the field, the 
PIN letters will be discontinued in all program areas. FMD 145 will 
remain in place and these letters will continue to be issued. 
Establishments will receive a copy of their EIR when the inspection is 
deemed closed based on 21 CFR 20.64(d).
    The 2001 IOM will be posted to FDA's website at www.fda.gov/ora 
under Inspection References/Investigations Operations Manual. The IOM 
sections that apply are: 510, 512.3, 516, 529 and 551.1. FMD 145 is 
posted to FDA's website at www.fda.gov/ora under Inspection References/
Field Management Directives.

    Dated: December 27, 2000.
John Marzilli,
Deputy Associate Commissioner for Regulatory Affairs.
[FR Doc. 01-141 Filed 1-3-01; 8:45 am]
BILLING CODE 4160-01-S