[Federal Register Volume 62, Number 96 (Monday, May 19, 1997)]
[Rules and Regulations]
[Pages 27183-27193]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13064]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 806

[Docket No. 91N-0396]


Medical Devices; Reports of Corrections and Removals

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule 
to establish procedures for implementing the reports of corrections and 
removals provisions of the Safe Medical Devices Act of 1990 (the SMDA) 
by requiring that manufacturers, importers, and distributors report 
promptly to FDA any corrections or removals of a device undertaken to 
reduce a risk to health posed by the device or to remedy a violation of 
the Federal Food, Drug, and Cosmetic Act (the act) caused by the device 
which may present a risk to health. FDA believes that this action is 
necessary to protect the public health by ensuring that the agency has 
current and complete information regarding those actions taken to 
reduce risks to health caused by the devices. Reports of such actions 
will improve the agency's ability to evaluate device-related problems 
and to take prompt action against potentially dangerous devices.

DATES: Effective November 17, 1997. Submit written comments on the 
information collection provisions of this final rule by July 18, 1997.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Rosa M. Gilmore, Center for Devices 
and Radiological Health (HFZ-215), Food and Drug Administration, 2094 
Gaither Rd., Rockville, MD 20850, 301-827-2970.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA's reporting and recordkeeping requirements for medical devices 
reflect a series of amendments to the act (21 U.S.C. 321-394) as 
follows: (1) The Medical Device Amendments of 1976 (Pub. L. 94-295) 
(the 1976 amendments) which amended the act to establish the first 
comprehensive framework for the regulation of medical devices; (2) the 
SMDA (Pub. L. 101-629), which amended the act to correct noted problems 
with the implementation and enforcement of the 1976 amendments; and (3) 
The Medical Device Amendments of 1992 (Pub. L. 102-300) (the 1992 
amendments), which amended certain provisions of the act relating to 
devices.
    Section 519(f) of the act (21 U.S.C. 360i(f)), as added by the 
SMDA, authorizes FDA to issue regulations to require reports and 
recordkeeping of correction and removal actions taken by device 
manufacturers, distributors, and importers. Under the final rule, a 
correction means the repair, modification, adjustment, relabeling, 
destruction, or inspection (including patient monitoring) of a device 
without its physical removal from its point of use to some other 
location. Removal means the physical removal of a device from its point 
of use to some other location for repair, modification, adjustment, 
relabeling, destruction, or inspection.
    Under section 519(f)(1) of the act, device manufacturers, 
distributors, and importers are to report promptly to FDA any 
correction or removal of a device undertaken: (1) To reduce a risk to 
health posed by the device; or (2) to remedy a violation of the act 
caused by a device which may present a risk to health. Section 
519(f)(1) of the act also requires manufacturers, distributors, and 
importers to keep records of those corrections and removals that are 
not required to be reported to FDA. Section 519(f)(2) of the act 
provides that no report of a correction or removal action under section 
519(f)(1) may be required if a report of the correction or removal 
action is required and has been submitted to FDA under section 519(a), 
which prescribes rules for reporting and keeping records of certain 
significant device-related events. Section 519(f)(3) of the act states 
that the terms ``correction'' and ``removal'' do not include routine 
servicing.
    The final rule provides a mechanism for FDA to receive timely 
information about potentially dangerous marketed devices by requiring 
device manufacturers, distributors, and importers to report promptly to 
FDA any correction or removal of a device undertaken to reduce a risk 
to health posed by the device, or to remedy a violation of the act 
caused by the device which may present a risk to health. Section 519(f) 
of the act was enacted because Congress was concerned that device 
manufacturers, distributors, and importers were carrying out product 
corrections or removals without notifying FDA, or without notifying the 
agency in a timely fashion (H. Rept. 808, 101st Cong., 2d sess. 29 
(1990)). Congress explained that industry's failure to report 
corrections and removals, particularly those undertaken to reduce risks 
associated with the use of a device, ``denies the agency the 
opportunity to fulfill its public health responsibilities by evaluating 
device-related problems and the adequacy of corrective actions'' (S. 
Rept. 513, 101st Cong., 2d sess. 23 (1990)), and ``has seriously 
interfered with FDA's ability to take prompt action against potentially 
dangerous devices'' (H. Rept. 808, 101st Cong., 2d sess. 29 (1990)).
    The agency recognizes that Congress did not want to overburden 
industry or FDA with excessive reporting

[[Page 27184]]

requirements and that the reporting requirements apply to the ``more 
important postmarket actions, excluding those events already reported 
to the [agency].'' (S. Rept. 513, 101st Cong., 2d sess. 23 (1990)). To 
ensure that FDA has access to all relevant information on corrections 
and removals, Congress provided that records be maintained for those 
corrections and removals that need not be reported.

II. Highlights of the Final Rule

    The agency has revised and clarified certain provisions of the 
final regulation. Further, the agency has narrowed the scope of the 
regulation to focus more explicitly on those corrections and removals 
that address more serious risks to health. The most significant changes 
from the March 23, 1994, proposed rule (59 FR 13828) to establish 
procedures to implement the reports of corrections and removals 
provisions of section 519(f) of the act (hereinafter referred to as the 
March 1994 proposed rule) follow:
    1. The definition of ``risk to health'' has been narrowed by 
revising Sec. 806.2(j) to focus explicitly on those corrections and 
removals undertaken to mitigate the potential for adverse health 
consequences. The revised definition of ``risk to health'' tracks the 
definitions of class I and class II recall in Sec. 7.3(m) (21 CFR 
7.3(m)).
    2. Section 806.10(e) has been added to allow a device manufacturer, 
importer, or distributor to disclaim that the submission of a required 
report of correction or removal is an admission that the device caused 
or contributed to a death or serious injury.
    3. Section 806.10(f) has been added to state clearly that a 
remedial action that is required and has been reported to the agency 
under part 803 (21 CFR part 803) (Medical Device Reporting), 21 CFR 
part 804 (Distributor Reporting), or part 1004 (21 CFR part 1004) 
(Repurchase, Repairs, or Replacement of Electronic Products) does not 
have to be resubmitted to the agency as a correction or removal report.
    4. FDA has added the definition of ``market withdrawal'' at 
Sec. 806.2(h) and has amended Sec. 806.1(b)(2) to make clear that 
market withdrawals are not reportable events.
    5. The requirement in Sec. 806.10(b) to submit reports within 10-
calendar days of initiating a correction or removal has been changed to 
10-working days.
    6. The agency has established an effective date of 180 days after 
publication of the final regulation for submission of reports of 
corrections and removals.
    7. The definition of ``U.S. designated agent'' has been deleted. 
FDA is reconsidering the duties of foreign manufacturers with respect 
to reporting under this rule and under part 803 and may propose a new 
rule to address this issue in the future.
    FDA believes that with these revisions, the final rule incorporates 
reasonable requirements that can be implemented by the regulated 
industry without unnecessary burden.

III. Summary and Analysis of Comments and FDA's Response

    The March 1994 proposed rule proposed to establish procedures to 
implement the reports of corrections and removals provisions of section 
519(f) of the act. FDA received 33 comments and 2 requests for an 
extension of the comment period in response to the March 1994 proposed 
rule. This total number represents comments received from 
manufacturers, distributors, trade associations, attorneys, and one 
hospital. For the most part, each comment addressed various aspects of 
the March 1994 proposed rule. Several of the comments stated that the 
March 1994 proposed rule was overly broad in scope, required the 
submission of unnecessary data, and imposed undue burdens on FDA and 
industry. Several comments also cited FDA's failure to address in the 
preamble the voluntary recall regulation, which was published in the 
Federal Register of June 16, 1978 (43 FR 26202), and the medical device 
reporting (MDR) regulation, which was published in the Federal Register 
of December 11, 1995 (60 FR 63578). Some of the comments stated that 
the definitions of certain regulatory terms lacked clarity. Other 
comments expressed concern regarding public disclosure of trade 
secrets, and confidential commercial and financial information in 
reports of corrections and removals submitted to FDA. FDA did not 
extend the comment period. The comments and FDA's responses are 
summarized below.
    1. Several comments stated that the proposed requirements for 
reports of corrections and removals should clarify the relationship 
between the reports of corrections and removals regulation and FDA's 
voluntary recall policy in part 7 (21 CFR part 7). FDA notes that the 
recall policy (including product corrections) in part 7 was not 
addressed in the preamble to the March 1994 proposed rule.
    In the voluntary recall regulation, FDA established the agency's 
policy and procedures for voluntary product recalls. This final notice 
was intended to provide guidance to manufacturers and distributors of 
all products regulated by FDA so that they could more effectively 
discharge their recall responsibilities. The voluntary guidelines apply 
to all FDA-regulated products (i.e. food, including animal feed; drugs; 
medical devices, including in vitro diagnostic products; cosmetics; and 
biological products intended for human use) except electronic products 
subject to the Radiation Control for Health and Safety Act (RCHSA) 
(Pub. L. 90-602) that are not medical devices, and may be undertaken at 
any time by manufacturers and distributors, or at the request of FDA. 
These voluntary guidelines remain in effect and will supplement the 
reports of correction and removal provisions of section 519(f) of the 
act. If a report of correction or removal is required under part 806 
(21 CFR part 806), it must be submitted as provided in Sec. 806.10. If 
a report is not required under part 806, an entity may voluntarily 
report under part 7. The definition of ``risk to health'' in this rule 
(Sec. 806.2(j)) tracks the definitions of class I and class II recall 
in Sec. 7.3(m). The effect of using the same language in part 806 is to 
require reports of corrections and removals for class I and class II 
recalls. Under part 806, manufacturers, importers, and distributors 
must keep records of events categorized as class III recalls under part 
7.
    Section 518(e) of the act (21 U.S.C. 360h(e)) provides FDA with the 
authority to initiate mandatory recall actions if there is a reasonable 
probability that a device intended for human use would cause serious 
adverse health consequences or death. In the Federal Register of 
November 20, 1996 (61 FR 59004), FDA published a final rule requiring 
recall of medical devices under some circumstances. Any corrective or 
removal action initiated by an FDA order under section 518(e) of the 
act need not be reported under part 806 because FDA will already be 
aware that the action is taking place. In such cases, reporting or 
notification requirements of the section 518(e) order and the recall 
regulation will be applicable.
    2. Comments stated that this rule duplicates the requirements of 
the MDR regulation (part 803). Other comments stated that it is unclear 
which events should be reported under the MDR regulation.
    FDA agrees that the relationship between this final rule and the 
MDR regulation warrants clarification so as to avoid unnecessary 
duplication. Indeed, section 519(f)(2) of the act prohibits FDA from 
requiring a report of correction or removal, if that same

[[Page 27185]]

information has been required and has been submitted under MDR.
    Generally, there is expected to be little overlap between these 
reporting requirements. This is because MDR's are based on adverse 
events that have occurred (i.e., deaths, serious injuries, and 
malfunctions) regardless of whether a remedial action (i.e., correction 
or removal) has been undertaken by the manufacturer or distributor. 
Moreover, the MDR report, which is tied to the adverse event itself and 
its possible association with the device, will only rarely address any 
remedial action taken by the manufacturer because, in most cases, no 
such remedial action has yet occurred.
    The primary area where such overlap between the final rule and MDR 
would be expected is with the 5-day MDR report. This is because 5-day 
MDR reports are required within 5 days of the submitter becoming aware 
that an MDR reportable event (i.e., death, serious injury, or 
malfunction) requires remedial action to prevent an unreasonable risk 
of substantial harm to the public health (Sec. 803.55). Thus, by 
linking the 5-day MDR reports to the need for remedial action, 
information concerning the correction or removal will necessarily be 
submitted under MDR and will not need to be resubmitted under part 806. 
FDA has modified the final rule to reflect this (Sec. 806.10(f)).
    In addition, in those rare cases where the routine MDR reports 
submitted to FDA (30-day reports for manufacturers and 10-day reports 
for distributors) are required to and do contain information on the 
remedial actions taken (i.e., corrections or removals), then no 
additional report under this final rule needs to be submitted to the 
agency.
    FDA notes that, under regulations issued to implement the RCHSA, 
the equivalent of a report of a correction or removal is required under 
part 1004 for electronic products which may also be medical devices. 
Part 1004 requires that, if an electronic product has a defect or fails 
to meet an applicable Federal performance standard, the manufacturer 
shall, repair, replace, or refund the cost of the electronic product. 
Devices for which Federal standards are currently in place under the 
RCHSA include x-ray equipment, fluoroscopy equipment, magnetic 
resonance imaging devices, medical lasers, and ultrasound devices.
    FDA believes that the information that is required by part 1004 is 
sufficient notice to FDA of a correction or removal. Furthermore, 
manufacturers of these products are familiar with the reporting 
requirements of part 1004. Therefore, on its own initiative, FDA is 
modifying Sec. 806.10(e) to state that, if a report is required and is 
submitted under part 1004 for a correction or removal that would 
otherwise be required to be reported under part 806, no report under 
part 806 is required.
    3. Comments questioned FDA's authority to review any correction or 
removal report to determine if the correction or removal action should 
be extended to other units of the same device, other products of the 
same manufacturer or distributor, or similar products of other 
manufacturers and distributors.
    FDA believes that it is appropriate and necessary, and in the 
interest of the public health, for FDA to review reports of corrections 
and removals to determine if any further remedial action such as a 
recall or safety alert is required, and to further determine if there 
is a need to extend the correction or removal action to other units of 
the same device, other products of the same manufacturer, distributor, 
or importer, or similar products of other manufacturers, distributors, 
or importers, which may present a similar risk to health.
    4. Some of the comments received in response to the March 1994 
proposed rule for reports of corrections and removals stated that 
manufacturers of general purpose articles, such as chemical reagents 
and laboratory equipment, are not subject to medical device 
regulations.
    Under Sec. 807.65(c) (21 CFR 807.65(c)), general purpose articles 
whose uses are generally known by persons trained in their use, unless 
labeled or promoted for medical use, are exempt from registration, 
listing, and premarket notification requirements. However, unless 
exempted by regulation, general purpose articles that are medical 
devices are subject to section 519(f) of the act and to the 
requirements of this rule.
    The March 1994 proposed rule at Sec. 806.1(b)(3) exempted certain 
actions undertaken by manufacturers of general purpose articles that 
were already exempted from reporting under Sec. 806.1(b)(1). The 
exemption that formerly appeared at Sec. 806.1(b)(3) does not appear in 
the final rule because it is redundant and unnecessary.
    5. Comments objected that the March 1994 proposed rule does not 
differentiate removals done solely upon customer request from other 
removals.
    Removals done solely upon customer request (i.e., overstock, 
discontinued use of the item, order error, old stock, not current 
design, or perceived issues with specific lots) that are not performed 
to reduce a risk to health posed by the device, or to remedy a 
violation of the act caused by the device that may present a risk to 
health, are not removals within the meaning of section 519(f)(1) of the 
act. FDA has amended Sec. 806.2 to include the definition of ``market 
withdrawal'' and Sec. 806.1(b)(2) to make clear that market withdrawals 
are not reportable events. The definition of market withdrawal in 
Sec. 806.2(h) tracks the definition in the voluntary recall provisions 
in Sec. 7.3(j). The example in Sec. 7.3(j) of ``routine equipment 
adjustments and repairs'' is not included in new Sec. 806.2(h) because 
it would be redundant to the definition of ``routine servicing'' in 
Sec. 806.2(k).
    6. Comments stated that it would be redundant to require 
convenience kit manufacturers to report when the supplier of the 
component initiates a correction or removal; to do so would be 
redundant and no additional value would be added to the process.
    FDA agrees that duplicate reports would be redundant, but disagrees 
that the rule requires duplicate reports. Only the person who initiates 
the correction or removal is required to report.
    7. Comments stated that the manufacturer should not be required to 
report if a manufacturer discovers after removing or correcting a 
medical device that the device did not pose a risk to health or that 
the risk posed was no greater than the risk described on the labeling 
of the device.
    A manufacturer, distributor, or importer that initiates a 
correction or removal of a device to reduce a risk to health or remedy 
a violation of the act that could present a risk to health must submit 
a report to FDA within 10-working days of initiation of the action. In 
most cases, if the action has been completed, it should have been 
reported. The only way the action would be exempt from reporting within 
the required 10-working days is if it was determined by the 
manufacturer, distributor, or importer during that 10-day period that 
the device did not present a risk to health, or there was no violation 
of the act that could present a risk to health. After a report is 
received by the agency, if FDA determines that there is no health risk, 
or violation of the act that could present a risk to health, FDA would 
not classify the action as a safety alert or as a recall under part 7, 
but more likely as a market withdrawal.
    8. Comments stated that distributors may not have the capacity to 
make the determination as to whether a given action is reportable. 
Other comments suggested that the reports of corrections and removals 
should not apply to drug wholesalers that distribute devices

[[Page 27186]]

because they have neither the authority nor the expertise to determine 
health risk or to undertake any corrections or removals of a 
manufacturer's product. Some comments stated that the definition of 
distributor in the March 1994 proposed rule is too broad.
    It is clear from the statute that Congress intended that 
distributors be required to submit reports of corrections and removals 
if they initiate a correction or removal action. The agency believes 
that the definition of distributor in Sec. 806.2(f) is sufficient. 
Narrowing this definition would prevent the agency from monitoring 
corrective action taken concerning adulterated or misbranded devices.
    9. Comments objected that routine reporting by distributors would 
disproportionately utilize the agency's resources.
    Section 519(f) of the act only requires distributors to report 
corrective or removal actions if they initiate the action and only one 
report for each correction or removal is required. Therefore, FDA does 
not believe that distributor reporting will disproportionately use the 
agency's resources.
    10. Comments said that device rental companies should be defined as 
multiple distributors and not manufacturers.
    The rule does not define rental companies as manufacturers. Rather, 
companies that rent devices would fall within the definition of 
``distributor'' (Sec. 806.2(f)) for the purposes of this rule. 
Manufacturers and distributors are subject to the same requirements 
under this rule to report and keep records of corrections and removals 
initiated by them.
    11. Some comments stated that the scope of the March 1994 proposed 
rule for reports of corrections and removals should apply to entities 
that refurbish or recondition a device for resale.
    Under section 519(f) of the act, the requirement for reporting 
corrections and removals applies to any manufacturer, importer, or 
distributor of a device, which would include a refurbisher and a 
reconditioner. Accordingly, if a refurbisher or refinisher of a device 
initiates a correction or removal, that refurbisher or reconditioner is 
responsible for reporting under part 806.
    12. Some comments stated that the reports of corrections and 
removals regulation should be written to exclude some medical devices 
which clearly pose no threat to the safety of the patient in case of 
label mixups.
    FDA believes that the request to exclude some medical devices which 
clearly pose no threat to the safety of the patient in case of label 
mixups is neither appropriate nor necessary. If a label mixup does not 
present a risk to the public health, no report is required.
    13. Comments suggested that the proposed regulation should be 
narrowed so as to focus more explicitly on those removals and 
corrections undertaken to mitigate the potential for serious illness or 
serious injury. Other comments stated that the threshold for reporting 
corrections and removals is too low.
    The agency believes that it is appropriate to narrow the scope of 
the regulation to focus more explicitly on those corrections and 
removals initiated to mitigate the potential for adverse health 
consequences. As discussed elsewhere in this regulation, FDA has 
revised the definition of ``risk to health'' (Sec. 806.2(j)) to enable 
the agency to focus its resources on more significant health problems.
    14. Comments said that FDA should add the following explicit 
examples of potential corrections and removals that are not intended to 
reduce a risk to health posed by the device or remedy a violation of 
the act: (1) When no injury has been, or is likely to be, associated 
with the event; (2) when a product has reached the end of its useful 
life; (3) when a device is returned to its original specifications due 
to extensive use; (4) when no cause for the device failure can be found 
following failure investigation; (5) where the withdrawal is for the 
purpose of retracting a new product line and/or upgrading the device to 
a more recent version; (6) where a request is made to return product 
for a complaint or MDR evaluation; or (7) when a device from a batch/
lot is needed to aid in the investigation of a complaint about the same 
batch/lot.
    The agency believes that it is not necessary to provide explicit 
examples of potential reports of corrections and removals that are not 
intended to reduce a risk to health posed by the device or remedy a 
violation of the act caused by the device that may present a risk to 
health. A firm may routinely correct or remove its devices in the 
marketplace or under its control for various reasons other than to 
reduce a risk to health or remedy a violation of the act that may 
present a risk to health. However, in response to these comments, FDA 
has added the definition of ``stock recovery'' at Sec. 806.2(l) and 
exempted actions meeting this definition from the reporting 
requirements at Sec. 806.1(b)(4). The definition of ``stock recovery'' 
in Sec. 806.2(l) tracks the definition in the voluntary recall 
provisions in Sec. 7.3(k). Only actions taken by a manufacturer can 
meet the definition of ``stock recovery.''
    15. Comments said that the scope of the March 1994 proposed rule 
should be broadened to include a definition of ``device enhancement''.
    The agency does not believe that it is necessary to define ``device 
enhancement''. If a correction or removal is initiated in order to 
enhance a device in the absence of a risk to health, no report is 
required. The central question is whether there is a risk to health and 
not whether the device is enhanced. Section 806.1(b) makes it clear 
that an action taken to improve a device in the absence of a risk to 
health is not a reportable event.
    16. Comments said that the requirement that only one report be 
submitted for each reportable event means that a reportable event is a 
specific correction or removal program for a defined population of 
devices rather than a correction or removal of an individual device. 
Other comments said that the proposed regulation appears to require 
reporting whenever a particular device is inspected, adjusted, or 
repaired in an identical way more than once even when the triggering 
events are random, are separated in time, and no program of repair or 
correction is in progress or is needed.
    FDA agrees that generally, a single correction or removal that 
involves more than one device requires only one report. However, when 
the triggering events for removals or corrections are the same but are 
separated in time, for example, when consecutive lots of a product with 
the same defect are not released at the same time, separate reports 
will have to be made for each event unless the timing is such that more 
than one event can be reported at once, given the time period for 
reporting in this regulation. FDA encourages manufacturers, 
distributors, and importers to consider whether it would be appropriate 
to extend removal or corrective actions performed in response to one 
event to other units of the same device or similar devices and, in some 
cases, this type of investigation may be required under part 820 (21 
CFR part 820). If multiple repairs of the same or similar devices are 
undertaken as part of a program of repair, the triggering incident and 
the entire program of repair can be submitted as one report. The agency 
will require amendments when additional devices, lots, and batches are 
being added to the same corrections or removal. This approach provides 
a more efficient and effective procedure for reporting actions that 
should be considered together. FDA has

[[Page 27187]]

added a new Sec. 806.10(d) to provide for the submission of such 
amendments.
    17. One comment states that a ``bug list'' distributed by device 
manufacturers to customers advising them of problems associated with 
software equipment used to run work stations could be considered a 
correction to software.
    A manufacturer, importer, or distributor that undertakes a 
corrective or removal action for computer software that is considered a 
medical device must submit a report of such action to FDA. If the 
action is taken to reduce a risk to health or to remedy a violation of 
the act that could present a risk to health caused by computerized 
software that comes within the definition of a device, a report must be 
submitted; however, it is not likely that a ``bug list'' would be 
considered a removal. A ``bug list'' could be considered a correction 
if it constitutes relabeling, but again, would only be reportable if it 
was undertaken to reduce a risk to health or to remedy a violation of 
the act that could present a risk to health.
    18. Some comments stated that the definition of risk to health was 
too broad; that the definition of ``risk to health'' should not include 
the terms ``or error in the use of the device''; that the definition of 
``risk to health'' should include ``error in the use of the device''; 
and that to impose these additional documentation and reporting 
requirements upon manufacturers adds a significant regulatory burden.
    FDA agrees that the definition of risk to health in the March 1994 
proposed rule is too broad. The agency has revised the definition of 
``risk to health'' at Sec. 806.2(j) to mean (1) a reasonable 
probability that the use of, or exposure to, the product will cause 
serious adverse health consequences or death, or (2) that use of, or 
exposure to, the product may cause temporary or medically reversible 
adverse health consequences, or an outcome where the probability of 
serious adverse health consequences is remote. The practical effect of 
adopting this revised definition is to require reports of removals and 
corrections for those corrective actions that would be classified as 
class I or class II recalls under Sec. 7.3(m). Moreover, the agency 
intends for ``serious adverse health consequences'' to have the same 
meaning as ``serious injury'' under the MDR rule. At Sec. 803.3(aa)(1), 
the MDR rule defines serious injury to mean an illness or injury that 
(1) is life-threatening; (2) results in permanent impairment of a body 
function or permanent damage to a body structure; or (3) necessitates 
medical or surgical intervention to preclude permanent damage to a body 
structure.
    This definition allows FDA to allocate its resources efficiently 
and precludes an unnecessary burden on manufacturers of reporting 
requirements for extremely remote, trivial risks to the public health. 
However, a correction or removal undertaken to alleviate a risk to 
health as defined by Sec. 806.2(j) must be reported under this section 
even if caused by user error. Reports about corrections or removals 
based on user error are important to FDA's ability to evaluate the 
problems with devices and to take prompt action against potentially 
dangerous devices.
    19. Comments said that the phrase ``to remedy a violation of the 
act caused by the device which may present a risk to health'' should be 
further clarified.
    Action taken to remedy a violation of the act means any action 
taken to bring a device that was not in compliance with any provision 
of the act into compliance or to prevent a noncompliance before it 
occurs.
    20. Comments said that the definitions of the terms ``correction'' 
and ``removal'' are overly broad and would require reports to FDA of 
thousands of service reports when a medical device is repaired. 
Further, comments said that the definition of routine servicing is 
extremely vague and open to subjective interpretation, while others 
said that this definition was overly restricted and unrealistic.
    FDA believes that the definitions of the terms ``correction'' and 
``removal'' are appropriate in scope. It is important to emphasize 
that, under the final rule, a report to FDA is required only when a 
specific action is taken to reduce a risk to health or to remedy a 
violation of the act that could result in a risk to health. Section 
519(f)(3) of the act states that the terms ``correction'' and 
``removal'' do not include routine servicing. As defined in 
Sec. 806.2(k) an action is considered ``routine servicing'' if it is 
conducted in accordance with a maintenance schedule for a device, or if 
it is a repair, adjustment, or replacement of parts in response to 
normal wear and tear of a device. An action is required to be reported 
only if it is specifically initiated to reduce a risk to health or 
remedy a violation of the act that could result in a risk to health. 
Under Sec. 806.1(b)(2), routine servicing is exempt from the reporting 
requirements of this regulation.
    21. Comments said that the definition of consignee is overly broad.
    FDA does not agree with these comments. FDA believes that the 
definition of ``consignee'' should be sufficiently broad to protect the 
public health. A correction or removal need only reach the level of 
consignee appropriate for the situation.
    22. A comment said that FDA should clarify the definition of ``U.S. 
designated agent''.
    The term ``U.S. designated agent'' was first introduced in the MDR 
regulation (Sec. 803.3(n)). In the Federal Register of July 23, 1996 
(61 FR 38346), FDA stayed the effective date of the U.S. designated 
agent provisions of the MDR rule and announced that it intended to 
reconsider reporting by foreign manufacturers and issue a new proposal 
in the near future. In keeping with that announcement, FDA has deleted 
the definition of ``U.S. designated agent'' that appeared in the March 
1994 proposed rule at Sec. 806.2(g)(4), from the reports of corrections 
and removals regulation. Foreign firms meeting the definition of 
``manufacturer,'' ``distributor,'' or ``importer'' are responsible for 
submitting their own reports of corrections and removals involving 
devices imported into the United States. Failure to do so will result 
in their devices being adulterated under section 502(t) of the act (21 
U.S.C. 352(t)) and may cause their devices to be refused admission for 
import under section 801(a) of the act (21 U.S.C. 381(a)).
    23. One comment stated that FDA should make the recordkeeping 
requirements advisory rather than mandatory. Another comment stated 
that the preamble is confusing in that it implies without stating that 
entities must supply justification for when reporting is not required.
    FDA disagrees with these comments. Section 519(f) of the act 
directs FDA to issue regulations to require reporting and recordkeeping 
of correction and removal actions. Section 519(f)(1) of the act 
requires manufacturers, distributors, and importers to keep records of 
those corrections and removals that are not required to be reported to 
FDA (see S. Rept. 513, 101st Cong., 2d sess. 23 (1990)). Section 
806.20(c)(4) requires explicitly that entities include the 
justification for not reporting a correction or removal in the records 
required by this rule. These records will be used by FDA to audit the 
manufacturer's determination that a report of correction or removal was 
not required. Similarly, Sec. 820.198 requires manufacturers to keep 
records of evaluations of complaints whether or not they are reportable 
under the MDR regulation.
    24. Several comments stated that the 10-calendar days in 
Sec. 806.10(b) within which to submit a report of a correction or 
removal is not enough time. Some

[[Page 27188]]

comments stated that the agency should clarify when a correction or 
removal is considered to be ``initiated''.
    FDA agrees with these comments. In order to allow sufficient time 
for preparation of complete reports, FDA has extended the reporting 
period to 10-working days. This will allow for a sufficient time for 
reporting when holidays or weekends intervene. However, the agency 
recognizes that, on rare occasions, a manufacturer or distributor will 
not be able to gather all the information required by Sec. 806.10 to 
complete a report. Therefore, FDA has revised the regulation by 
including Sec. 806.10(b)(13) to allow manufacturers and distributors to 
identify information that is not available, provided that they state 
when it will be available.
    Although the SMDA does not specifically define the term 
``initiation'' or ``initiating'', FDA believes that the initiation or 
initiating of a correction or removal is that moment in time when a 
firm makes the first contact within or outside the firm that begins the 
correction or removal action.
    25. One comment stated that the information manufacturers would be 
required to report is far in excess of that which FDA needs for a 
reporting program, especially in light of the many other controls and 
reporting programs already in effect that require companies to maintain 
records and/or make reports about the same type of information. Another 
comment stated that the criteria for submission of reports of 
corrections and removals are too subjective and may be difficult to 
apply in actual practice.
    FDA agrees with these comments and, as noted above, has narrowed 
the definition of ``risk to health.'' The final rule, as revised, 
applies basically the criteria for class I and class II recalls used 
successfully by FDA for more than 20 years under part 7.
    26. One comment stated that a form for reporting corrections and 
removals would be useful, particularly if it served as a checklist of 
required information but allowed flexibility in providing the 
information. The comment also stated that it would be helpful if 
electronic or disc submissions were possible. One comment stated that a 
form would be impractical as it would not allow the flexibility 
necessary to accommodate various needs. One comment developed and 
submitted a form for use by the agency.
    In the March 1994 proposed rule, FDA solicited comments regarding 
whether it would be desirable to develop a form to collect reports of 
correction and removal data. FDA has determined that a form is not 
necessary. FDA believes that industry and the agency have more 
flexibility without a form without sacrificing good information 
management practices.
    In the Federal Register of March 20, 1997 (62 FR 13430), FDA 
published a final rule that will, under certain circumstances, permit 
the submission of electronic records, electronic signatures, and 
handwritten signatures executed to electronic records as generally 
equivalent to paper records and handwritten signatures executed on 
paper. The rule will apply to records that are called for in title 21 
of the Code of Federal Regulations (CFR) when submitted in electronic 
form. The intended effect of the March 1994 proposed rule is to permit 
use of electronic technologies in a manner that is consistent with 
FDA's overall mission and that preserves the integrity of the agency's 
enforcement activities.
    27. One comment stated that a manufacturer may be admitting product 
liability if the manufacturer is required to submit a report for a 
correction or removal of a device when the regulation requiring the 
report is based upon ``risk to health''. The comment stated that the 
proposed regulation should be amended to allow a manufacturer to 
disclaim the admission of risk to health associated with a device by 
the mere submission of this required report.
    In response to the comment, FDA has added Sec. 806.10(e) to the 
final rule stating that a report of information submitted by a 
manufacturer, distributor, or importer (and any release by FDA of that 
report or information) does not necessarily reflect a conclusion by the 
manufacturer, importer, distributor, or FDA that the report or 
information constitutes an admission that the device caused or 
contributed to a death or serious injury. A manufacturer, distributor, 
or importer need not admit, and may deny, that the report or 
information submitted under this section constitutes an admission that 
the device caused or contributed to a death or serious injury.
    28. Some comments stated that the term ``complete'' is subjective 
and should be deleted from Sec. 806.10(c)(7), which required ``A 
complete description of the event(s) giving rise to the information 
reported and the corrective or removal actions that have been, and are 
expected to be, taken'' (emphasis added), and Sec. 806.20(b)(3), which 
required ``A complete description of the event giving rise to the 
information reported and the corrective or removal action that has 
been, and is expected to be taken.''
    FDA agrees with these comments. The term ``complete'' has been 
deleted from these sections of the regulation.
    29. One comment stated that the word ``inspection'' should be 
deleted from the definition of correction. According to this comment, 
the act of inspecting is not, per se, an event which corrects a device. 
The comment said that, while an action of correction could result from 
an inspection event, the process of determining if a correction is 
warranted should not be a reportable event under part 806.
    FDA agrees an inspection that is conducted before a determination 
that a public health risk exists is not a reportable event. However, 
FDA believes that an inspection that is initiated as a result of a 
public health risk is a correction. The term ``inspection (including 
patient monitoring)'' is included in the definition of ``correction'' 
in Sec. 7.3. FDA has in the past classified firms' inspections that 
were conducted to determine which device contained a defective 
component as recall actions, especially when a firm failed to maintain 
adequate records to determine which devices were manufactured with a 
possible defect, or which consignees received defective devices.
    30. Some comments stated that the proposed requirement with regard 
to the number scheme for ``C'' (correction) and ``R'' (removal) type 
reports is not clear. Another comment stated that FDA has exceeded the 
scope of its statutory authority in mandating a specific reporting 
format for reports of corrections and removals. Other comments stated 
that manufacturers should be provided with the option of designating 
their own report numbers. Another comment stated that requiring the 
creation of an 18 character alpha-numeric field for computer data bases 
to identify, track, and retrieve associated information in the 
correction or removal report number section adds unnecessary additional 
requirements to the recordkeeping task for manufacturers, and that 
perhaps the existing unique sequence number that each manufacturer uses 
to identify their product complaints should be adequate.
    FDA believes that the number scheme for ``C'' (corrections) and 
``R'' (removal) type reports should be clarified, and has clarified the 
numbering system in Sec. 806.10(c)(1). FDA does not believe that it has 
exceeded its statutory authority. A uniform numbering system for 
reports of corrections and removals will assist the agency, in filing, 
organizing, and retrieving reports of corrections and removals. By 
facilitating the agency's orderly processing of reports, a uniform 
numbering system will ensure the agency's prompt and efficient 
attention to the information submitted. Moreover,

[[Page 27189]]

as discussed above in response to comment 26, the agency has published 
a rule that will permit electronic submissions of some reports. A 
uniform numbering system will greatly simplify the storage and 
retrieval of electronic reports.
    31. One comment stated that the current practice is for 
manufacturers or distributors reporting a recall action to report to 
the FDA district office in the area where the manufacturer's or 
distributor's site conducting the recall is located. The comment stated 
that a report of correction or removal should be submitted to the FDA 
district office with jurisdiction over the location of the manufacturer 
that is conducting the correction/removal action. Some comments stated 
that the reports of corrections and removals should be submitted to the 
FDA district office in which the facility coordinating the correction 
or removal is located. Other comments stated that reports should be 
made to FDA headquarters rather than to each district office.
    FDA believes that reports of corrections and removals should be 
sent to the district office for the district in which the reporting 
facility is located, whether it is the distributor's site, 
manufacturing site, or the corporate office. The district office in the 
reporting facility's district will have direct contact with the 
reporting firm, as it does now with recalling firms, and will therefore 
be able to monitor the firm's actions more easily, and in a timely 
fashion. Manufacturers, distributors, and importers are expected to 
follow company policy for submission of reports of actions involving 
multiple operations. For foreign firms, reports should be made to the 
district office of the district in which any initial distributor of the 
device in the United States is located.
    32. One comment stated that the March 1994 proposed rule will 
impose significant costs on manufacturers and distributors of medical 
devices. Some comments stated that the projection of no more than 800 
reports per year grossly underestimates the likely number. Other 
comments stated that the cost is underestimated.
    FDA has revised aspects of the final rule, in particular the 
definition of ``risk to health,'' as discussed above. FDA believes that 
these revisions substantially narrow the definition of reportable 
events. Based on the number of voluntary recalls reported to FDA since 
1990 and the number of unreported recalls identified through FDA's 
investigations, the estimate provided in the March 1994 proposed rule 
for 800 reports should be adjusted slightly upward to 880. The agency 
typically uncovers 40 unreported events annually. FDA's estimates are 
discussed in more detail in sections IV and V of this document. FDA 
believes that the information it has used to project the number of 
reports is reliable and that 800 to 880 reports is a rational, well-
justified estimate of the number of reports the agency will receive.
    33. Some comments expressed concern over confidentiality of the 
reports of corrections and removals submitted to FDA. For the most 
part, comments recommended that FDA delete the names, addressees, and 
telephone numbers of consignees prior to public disclosure of reports 
of corrections and removals.
    FDA is aware of confidentiality concerns. For the most part, FDA is 
required under the Freedom of Information Act (FOIA) (5 U.S.C. 552), to 
make reports of corrections and removals publicly available. The public 
availability of such reports is governed by the FOIA and part 20 (21 
CFR part 20). Before a report is made publicly available in accordance 
with the FOIA and part 20, FDA will delete from the report information 
whose disclosure would constitute an invasion of personal privacy (see 
5 U.S.C. 552(b)(6); Sec. 20.63), or information that constitutes trade 
secret or confidential commercial or financial information (see 5 
U.S.C. 552(b)(4); Sec. 20.61). The public availability of the reports 
required by this regulation is discussed in Sec. 806.40.

II. Enforcement

    Violations of this rule, which is issued under the authority of 
sections 502, 510, 519, 520, 701, and 704 of the act (21 U.S.C. 
sections 352, 360, 360i, 360j, 371, and 374), will result in committing 
one or more of the following violations of section 301 of the act:
    1. Section 301(e) of the act (21 U.S.C. 331(e)), which prohibits, 
among other things, the failure to establish or maintain any record, or 
make any report, required under section 519 of the act or the refusal 
to permit officers or employees designated by FDA to have access to or 
verification or copying of any such required record.
    2. Section 301(f) of the act, which prohibits the refusal to permit 
entry or inspection as authorized by section 704 of the act (21 U.S.C. 
374). Section 704(e) of the act requires every person required under 
section 519 of the act to maintain records and every person who is in 
charge or custody of such records, upon request of an officer or 
employee designated by FDA, to permit such officer or employee to have 
access to, and copy and verify, such records.
    3. Section 301(q) of the act, which prohibits, among other things, 
the failure or refusal to furnish any material or information required 
by or under section 519 of the act or the submission of such a report 
that is false or misleading in any respect.
    In addition, section 502(t)(2) of the act deems a device to be 
misbranded if there was a failure or refusal to furnish any material or 
information required by or under section 519 of the act respecting the 
device. Section 301(a), (b), (c), (g), and (k) of the act prohibit 
several actions with respect to misbranded devices. Persons who violate 
section 301 of the act may be restrained, under section 302 of the act 
(21 U.S.C. 332), or may be imprisoned or fined under section 303 of the 
act (21 U.S.C. 333). FDA may also seize misbranded devices under 
section 304 of the act (21 U.S.C. 334).
    The SMDA also added section 303(f) to the act, which provides for 
the first time that any person who fails to demonstrate substantial 
compliance with section 519(f) of the act may be subject to civil 
penalties. These penalties do not apply to any person who commits minor 
violations of section 519(f) of the act with respect to correction 
reports, if such person demonstrates substantial compliance with 
section 519(f). A civil penalty may not exceed $15,000 for a single 
violation, and may not exceed $1,000,000 for all such violations 
adjudicated in a single proceeding.

III. Environmental Impact

    The agency has determined that this action falls within the 
category of actions described in 21 CFR 25.24(a)(8) which do not 
individually or cumulatively have a significant effect on the human 
environment. Therefore, neither an environmental assessment nor an 
environmental impact statement is required.

IV. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612). 
Executive Order 12866 directs agencies to assess all costs and benefits 
of available regulatory alternatives, and when regulation is necessary, 
to select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity. The agency believes that 
this final rule is consistent with the regulatory philosophy and 
principles identified in the Executive Order. If a rule has a 
significant

[[Page 27190]]

economic impact on a substantial number of small entities, the 
Regulatory Flexibility Act requires agencies to analyze regulatory 
options that would minimize any significant impact of the rule on small 
entities.
    The final rule requires medical device manufacturers, importers, 
and distributors to report promptly to FDA any correction or removal of 
a device undertaken to reduce a risk to health posed by the device or 
to remedy a violation of the act that could present a risk to health 
caused by the device. FDA currently receives, as voluntary reports 
under part 7, an estimated 800 reports of corrections and removals each 
year and typically uncovers an additional 40 unreported events. 
Factoring in an additional 40 reports that FDA does not uncover, FDA 
estimates that it will receive about 880 reports of corrections and 
removals under Sec. 806.10 annually and that entities will be required 
to keep records of an additional 440 events. There are more than 20,000 
manufacturers, importers, and distributors of medical devices subject 
to this rule. The large majority of entities will not be required to 
submit any reports in any particular year, and, most likely, only the 
largest entities would be required to report more than 1 or 2 events in 
any year. Because of the relatively small incremental increase in 
reporting and recordkeeping required by this rule and the relatively 
modest costs attendant upon that increase, the Commissioner of Food and 
Drugs certifies that the final rule will not have a significant 
economic impact on a substantial number of small entities. The factual 
basis for this certification is the estimate that the implementation of 
the corrections and removals provision will require approximately 880 
reports per year and recordkeeping of approximately 440 events. 
Therefore, under the Regulatory Flexibility Act, no further analysis is 
required. FDA has sent its certification and the factual basis for it 
set out above to the Chief Counsel for Advocacy, Small Business 
Administration.

V. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The title, 
description, and respondent description of the information collection 
provisions are shown below with an estimate of the annual reporting and 
recordkeeping burden. Included in the estimate is the time for 
reviewing instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing the 
collection of information.
    Title: Reports of Corrections and Removals for Manufacturers, 
Importers, and Distributors of Medical Devices.
    Description: This regulation establishes the procedures for 
implementing the reports of corrections and removals provisions of the 
SMDA. The purpose of this regulation is to protect the public health by 
permitting FDA to promptly receive information about devices that have 
been corrected or removed to avert a risk to health or to remedy a 
violation of the act that could present a risk to health. The 
collection of this information is required by section 519(f) of the 
act.
    Description of Respondents: Businesses or other for profit 
organizations.

                                   Table 1.--Estimated Annual Reporting Burden                                  
----------------------------------------------------------------------------------------------------------------
                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
----------------------------------------------------------------------------------------------------------------
806.10                                880               1             880              10           8,800       
----------------------------------------------------------------------------------------------------------------


                                 Table 2.--Estimated Annual Recordkeeping Burden                                
----------------------------------------------------------------------------------------------------------------
                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper                 
----------------------------------------------------------------------------------------------------------------
806.20                                440               1             440              10           4,400       
----------------------------------------------------------------------------------------------------------------
There are no capital or operating and maintenance costs expected as a result of this final rule.                

    Although the March 1994 proposed rule provided a 90-day comment 
period under the Paperwork Reduction Act of 1980, and this final rule 
is based on comments received, the proposed rule has not been 
previously available to OMB for review. FDA invites comments on: (1) 
Whether the proposed collection of information is necessary for the 
proper performance of FDA's functions, including whether the 
information will have practical utility; (2) the accuracy of FDA's 
estimate of the burden of the proposed collection of information, 
including the validity of the methodology and assumptions used; (3) 
ways to enhance the quality, utility, and clarity of the information to 
be collected; and (4) ways to minimize the burden of the collection of 
information on respondents, including through use of automated 
collection techniques, when appropriate, and other forms of information 
technology.
    Although the reporting burden estimate in the March 1994 proposed 
rule was 8,000 hours, based on an evaluation of the agency's recent 
experience with the voluntary recall rule and the MDR rule, FDA now 
estimates that the annual reporting burden for respondents in 
Sec. 806.10 is 8,800 hours. The adjusted total estimated annual 
recordkeeping burden is now 4,400 hours (Table 1).
    Individuals and organizations desiring to submit comments regarding 
FDA's burden estimates or any aspects of the information collection 
provisions of the final rule should do so by July 18, 1997. These 
comments should be directed to FDA's Dockets Management Branch (address 
above).
    At the close of the 60-day comment period, FDA will review the 
comments received, revise the information collection provisions as 
necessary, and submit these provisions to OMB for review. FDA will 
publish a notice in the Federal Register when the information 
collection provisions are submitted to OMB, and an opportunity for 
public comment to OMB will be provided at that time. Prior to the 
effective date of this final rule, FDA will publish a notice in the 
Federal Register of OMB's

[[Page 27191]]

decision to approve, modify, or disapprove the information collection 
provisions. An agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays 
a currently valid OMB control number.

List of Subjects in 21 CFR Part 806

    Corrections and removals, Medical devices, Reporting and 
recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
806 is added to read as follows:

PART 806--MEDICAL DEVICE CORRECTIONS AND REMOVALS

Subpart A--General Provisions

Sec.
806.1  Scope.
806.2  Definitions.

Subpart B--Reports and Records

806.10  Reports of corrections and removals.
806.20  Records of corrections and removals not required to be 
reported.
806.30  FDA access to records.
806.40  Public availability of reports.

    Authority: Secs. 502, 510, 519, 520, 701, and 704 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 352, 360, 360i, 360j, 371, 
374).

Subpart A--General Provisions


Sec. 806.1  Scope.

    (a) This part implements the provisions of section 519(f) of the 
Federal Food, Drug, and Cosmetic Act (the act) requiring device 
manufacturers and distributors, including importers, to report promptly 
to the Food and Drug Administration (FDA) certain actions concerning 
device corrections and removals, and to maintain records of all 
corrections and removals regardless of whether such corrections and 
removals are required to be reported to FDA.
    (b) The following actions are exempt from the reporting 
requirements of this part:
    (1) Actions undertaken by device manufacturers and distributors, 
including importers, to improve the performance or quality of a device 
but that do not reduce a risk to health posed by the device or remedy a 
violation of the act caused by the device.
    (2) Market withdrawals as defined in Sec. 806.2(h).
    (3) Routine servicing as defined in Sec. 806.2(k).
    (4) Stock recoveries as defined in Sec. 806.2(l).


Sec. 806.2  Definitions.

    As used in this part:
    (a) ``Act'' means the Federal Food, Drug, and Cosmetic Act.
    (b) ``Agency'' or ``FDA'' means the Food and Drug Administration.
    (c) ``Consignee'' means any person or firm that has received, 
purchased, or used a device subject to correction or removal.
    (d) ``Correction'' means the repair, modification, adjustment, 
relabeling, destruction, or inspection (including patient monitoring) 
of a device without its physical removal from its point of use to some 
other location.
    (e) ``Correction or removal report number'' means the number that 
uniquely identifies each report submitted.
    (f) ``Distributor'' means any person, including any person who 
imports a device into the United States, who furthers the marketing of 
a device from the original place of manufacture to the person who makes 
final delivery or sale to the ultimate user, but who does not repackage 
or otherwise change the container, wrapper, or labeling of the device 
or device package.
    (g) ``Manufacturer'' means any person who manufactures, prepares, 
propagates, compounds, assembles, or processes a device by chemical, 
physical, biological, or other procedures. The term includes any person 
who:
    (1) Repackages or otherwise changes the container, wrapper, or 
labeling of a device in furtherance of the distribution of the device 
from the original place of manufacture to the person who makes final 
delivery or sale to the ultimate user or consumer;
    (2) Initiates specifications for devices that are manufactured by a 
second party for subsequent distribution by the person initiating the 
specifications; or
    (3) Manufactures components or accessories which are devices that 
are ready to be used and are intended to be commercially distributed 
and are intended to be used as is, or are processed by a licensed 
practitioner or other qualified person to meet the needs of a 
particular patient.
    (h) ``Market withdrawal'' means a correction or removal of a 
distributed device that involves a minor violation of the act that 
would not be subject to legal action by FDA or that involves no 
violation of the act, e.g., normal stock rotation practices.
    (i) ``Removal'' means the physical removal of a device from its 
point of use to some other location for repair, modification, 
adjustment, relabeling, destruction, or inspection.
    (j) ``Risk to health'' means
    (1) A reasonable probability that use of, or exposure to, the 
product will cause serious adverse health consequences or death; or
    (2) That use of, or exposure to, the product may cause temporary or 
medically reversible adverse health consequences, or an outcome where 
the probability of serious adverse health consequences is remote.
    (k) ``Routine servicing'' means any regularly scheduled maintenance 
of a device, including the replacement of parts at the end of their 
normal life expectancy, e.g., calibration, replacement of batteries, 
and responses to normal wear and tear. Repairs of an unexpected nature, 
replacement of parts earlier than their normal life expectancy, or 
identical repairs or replacements of multiple units of a device are not 
routine servicing.
    (l) ``Stock recovery'' means the correction or removal of a device 
that has not been marketed or that has not left the direct control of 
the manufacturer, i.e., the device is located on the premises owned, or 
under the control of, the manufacturer, and no portion of the lot, 
model, code, or other relevant unit involved in the corrective or 
removal action has been released for sale or use.

Subpart B--Reports and Records


Sec. 806.10  Reports of corrections and removals.

    (a) Each device manufacturer, importer, or distributor shall submit 
a written report to FDA of any correction or removal of a device 
initiated by such manufacturer or distributor if the correction or 
removal was initiated:
    (1) To reduce a risk to health posed by the device; or
    (2) To remedy a violation of the act caused by the device which may 
present a risk to health unless the information has already been 
provided as set forth in paragraph (f) of this section or the 
corrective or removal action is exempt from the reporting requirements 
under Sec. 806.1(b).
    (b) The manufacturer, importer, or distributor shall submit any 
report required by paragraph (a) of this section within 10-working days 
of initiating such correction or removal. The report shall be submitted 
to the appropriate FDA district office listed in Sec. 5.115 of this 
chapter. A foreign manufacturer or owner or operator of devices must 
submit reports of corrective or removal actions.
    (c) The manufacturer, importer, or distributor shall include the 
following information in the report:
    (1) The seven digit registration number of the entity responsible 
for

[[Page 27192]]

submission of the report of corrective or removal action (if 
applicable), the month, day, and year that the report is made, and a 
sequence number (i.e., 001 for the first report, 002 for the second 
report, 003 etc.), and the report type designation ``C'' or ``R''. For 
example, the complete number for the first correction report submitted 
on June 1, 1997, will appear as follows for a firm with the 
registration number 1234567: 1234567-6/1/97-001-C. The second 
correction report number submitted by the same firm on July 1, 1997, 
would be 1234567-7/1/97-002-C etc. For removals, the number will appear 
as follows: 1234567-6/1/97-001-R and 1234567-7/1/97-002-R, etc. Firms 
that do not have a seven digit registration number may use seven zeros 
followed by the month, date, year, and sequence number (i.e. 0000000-6/
1/97-001-C for corrections and 0000000-7/1/97-001-R for removals). 
Reports received without a seven digit registration number will be 
assigned a seven digit central file number by the district office 
reviewing the reports.
    (2) The name, address, and telephone number of the manufacturer, 
importer, or distributor and the name, title, address, and telephone 
number of the manufacturer, importer, or distributor's representative 
responsible for conducting the device correction or removal.
    (3) The brand name and the common name, classification name, or 
usual name of the device and the intended use of the device.
    (4) Marketing status of the device, i.e., any applicable premarket 
notification number, premarket approval number, or indication that the 
device is a preamendments device, and the device listing number. A 
manufacturer, importer, or distributor that does not have an FDA 
establishment registration number shall indicate in the report whether 
it has ever registered with FDA.
    (5) The model, catalog, or code number of the device and the 
manufacturing lot or serial number of the device or other 
identification number.
    (6) The manufacturer's name, address, telephone number, and contact 
person if different from that of the person submitting the report.
    (7) A description of the event(s) giving rise to the information 
reported and the corrective or removal actions that have been, and are 
expected to be taken.
    (8) Any illness or injuries that have occurred with use of the 
device. If applicable, include the medical device report numbers.
    (9) The total number of devices manufactured or distributed subject 
to the correction or removal and the number in the same batch, lot, or 
equivalent unit of production subject to the correction or removal.
    (10) The date of manufacture or distribution and the device's 
expiration date or expected life.
    (11) The names, addresses, and telephone numbers of all domestic 
and foreign consignees of the device and the dates and number of 
devices distributed to each such consignee.
    (12) A copy of all communications regarding the correction or 
removal and the names and addresses of all recipients of the 
communications not provided in accordance with paragraph (c)(11) of 
this section.
    (13) If any required information is not immediately available, a 
statement as to why it is not available and when it will be submitted.
    (d) If, after submitting a report under this part, a manufacturer, 
distributor, or importer determines that the same correction or removal 
should be extended to additional lots or batches of the same device, 
the manufacturer, distributor, or importer shall within 10-working days 
of initiating the extension of the correction or removal, amend the 
report by submitting an amendment citing the original report number 
assigned according to paragraph (c)(1) of this section, all of the 
information required by paragraph (c)(2), and any information required 
by paragraphs (c)(3) through (c)(12) of this section that is different 
from the information submitted in the original report. The 
manufacturer, distributor, or importer shall also provide a statement 
in accordance with paragraph (c)(13) of this section for any required 
information that is not readily available.
    (e) A report submitted by a manufacturer, distributor, or importer 
under this section (and any release by FDA of that report or 
information) does not necessarily reflect a conclusion by the 
manufacturer, distributor, importer, or FDA that the report or 
information constitutes an admission that the device caused or 
contributed to a death or serious injury. A manufacturer, distributor, 
or importer need not admit, and may deny, that the report or 
information submitted under this section constitutes an admission that 
the device caused or contributed to a death or serious injury.
    (f) No report of a correction or removal is required under this 
part, if a report of the correction or removal is required and has been 
submitted under parts 803, 804, or 1004 of this chapter.


Sec. 806.20  Records of corrections and removals not required to be 
reported.

    (a) Each device manufacturer, importer, or distributor who 
initiates a correction or removal of a device that is not required to 
be reported to FDA under Sec. 806.10 shall keep a record of such 
correction or removal.
    (b) Records of corrections and removals not required to be reported 
to FDA under Sec. 806.10 shall contain the following information:
    (1) The brand name, common or usual name, classification, name and 
product code if known, and the intended use of the device.
    (2) The model, catalog, or code number of the device and the 
manufacturing lot or serial number of the device or other 
identification number.
    (3) A description of the event(s) giving rise to the information 
reported and the corrective or removal action that has been, and is 
expected to be taken.
    (4) Justification for not reporting the correction or removal 
action to FDA, which shall contain conclusions and any followups, and 
be reviewed and evaluated by a designated person.
    (5) A copy of all communications regarding the correction or 
removal.
    (c) The manufacturer, importer, or distributor shall retain all 
records required under this section for a period of 2 years beyond the 
expected life of the device, even if the manufacturer, importer, or 
distributor has ceased to manufacture, import, or distribute the 
device. Records required to be maintained under paragraph (b) of this 
section must be transferred to the new manufacturer, importer, or 
distributor of the device and maintained for the required period of 
time.


Sec. 806.30  FDA access to records.

    Each device manufacturer, importer, or distributor required under 
this part to maintain records concerning corrections or removals and 
every person who is in charge or custody of such records shall, upon 
request of an officer or employee designated by FDA and under section 
704(e) of the act, permit such officer or employee at all reasonable 
times to have access to, and to copy and verify, such records and 
reports.


Sec. 806.40  Public availability of reports.

    (a) Any report submitted under this part is available for public 
disclosure in accordance with part 20 of this chapter.
    (b) Before public disclosure of a report, FDA will delete from the 
report:
    (1) Any information that constitutes trade secret or confidential 
commercial or financial information under Sec. 20.61 of this chapter; 
and

[[Page 27193]]

    (2) Any personnel, medical, or similar information, including the 
serial numbers of implanted devices, which would constitute a clearly 
unwarranted invasion of personal privacy under Sec. 20.63 of this 
chapter or 5 U.S.C. 552(b)(6); provided, that except for the 
information under Sec. 20.61 of this chapter or 5 U.S.C. 552(b)(4), FDA 
will disclose to a patient who requests a report all the information in 
the report concerning that patient.

    Dated: May 9, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-13064 Filed 5-16-97; 8:45 am]
BILLING CODE 4160-01-F