Document ID: FDA-2016-N-0406-0014
Agency: fda
Document Type: Rule
Title: Medical Devices: Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories
Posted Date: 2018-05-18T04:00Z

[Federal Register Volume 83, Number 97 (Friday, May 18, 2018)]
[Rules and Regulations]
[Pages 23212-23218]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10610]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 864

[Docket No. FDA-2016-N-0406]

Medical Devices; Hematology and Pathology Devices; Classification 
of Blood Establishment Computer Software and Accessories

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
issuing a final rule to classify blood establishment computer software 
(BECS) and BECS accessories (regulated under product code MMH) into 
class II (special controls). FDA has identified special controls for 
BECS and BECS accessories that are necessary to provide a reasonable 
assurance of safety and effectiveness. FDA is also giving notice that 
the Agency does not intend to exempt BECS and BECS accessories from 
premarket notification requirements of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act).

DATES: This rule is effective June 18, 2018.

ADDRESSES: For access to the docket to read background documents or 
comments received, go to https://www.regulations.gov and insert the 
docket number found in brackets in the heading of this final rule into 
the ``Search'' box and follow the prompts, and/or go to the Dockets 
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jessica Walker Udechukwu, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 
240-402-7911.

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Executive Summary
    A. Purpose of the Final Rule
    B. Summary of the Major Provisions of the Final Rule
    C. Legal Authority
    D. Costs and Benefits
II. Background
    A. Need for the Regulation/History of This Rulemaking
    B. Summary of Comments to the Proposed Rule
III. Legal Authority
IV. Comments on the Proposed Rule and FDA Response
    A. Introduction
    B. Specific Comments and FDA Response
V. Effective Date
VI. Economic Analysis of Impacts
VII. Analysis of Environmental Impact
VIII. Paperwork Reduction Act of 1995
IX. Federalism
X. Consultation and Coordination With Indian Tribal Governments
XI. References

I. Executive Summary

A. Purpose of the Final Rule

    FDA is classifying BECS and BECS accessories into class II (special 
controls). The Agency believes that the special controls established 
and imposed by this final rule, together with the general controls, 
will provide reasonable assurance of the safety and effectiveness of 
these devices. In this final rule, FDA is also revising the definition 
of BECS accessories from the definition in the proposed rule and 
responding to comments received on the proposed rule. Lastly, FDA is 
giving notice that the Agency does not intend to exempt BECS and BECS 
accessories from the premarket notification requirements of the FD&C 
Act.

B. Summary of the Major Provisions of the Final Rule

    In this final rule, FDA is classifying BECS and BECS accessories 
into class II (special controls). This rule creates Sec.  864.9165 in 
21 CFR part 864, subpart J, to include the identification and 
classification of BECS and BECS accessories. The classification of BECS 
and BECS accessories is consistent with the FDA Blood Product Advisory 
Committee (BPAC) recommendation that the devices be classified as class 
II (special controls) devices with premarket review.

C. Legal Authority

    We are issuing this final rule under section 513(a)(1)(B) of the 
FD&C Act (21 U.S.C. 360c(a)(1)(B)). FDA has the authority under this 
provision of the FD&C Act to issue a regulation to establish special 
controls for class II

[[Page 23213]]

devices for which general controls by themselves are insufficient to 
provide reasonable assurance of safety and effectiveness of the device, 
and for which there is sufficient information to establish special 
controls to provide such assurance. Under this authority, FDA is 
establishing special controls for BECS and BECS accessories.

D. Costs and Benefits

    FDA is finalizing this regulation to classify BECS and BES 
accessories into class II (special controls). Because this final rule 
would not impose significant new obligations on manufacturers, this 
regulation is not anticipated to result in any significant new 
compliance costs and the economic impact is expected to be minimal.

II. Background

    The FD&C Act (21 U.S.C. 301 et seq.), as amended by the Medical 
Device Amendments of 1976 (1976 Amendments), establishes a 
comprehensive system for the regulation of medical devices intended for 
human use. Section 513 of the FD&C Act establishes three categories 
(classes) of devices depending on the regulatory controls needed to 
provide reasonable assurance of their safety and effectiveness. The 
three categories of devices are class I (general controls), class II 
(special controls), and class III (premarket approval).
    Class I devices are those devices for which the general controls of 
the FD&C Act (controls authorized by or under sections 501, 502, 510, 
516, 518, 519, or 520 or any combination of such sections) are 
sufficient to provide reasonable assurance of safety and effectiveness 
of the device. Class I also includes those devices for which 
insufficient information exists to determine that general controls are 
sufficient to provide reasonable assurance of safety and effectiveness 
or to establish special controls to provide such assurance, but because 
the devices are not purported or represented to be for a use in 
supporting or sustaining human life or for a use which is of 
substantial importance in preventing impairment of human health, and do 
not present a potential unreasonable risk of illness or injury, are to 
be regulated by general controls (section 513(a)(1)(A) of the FD&C 
Act). Class II devices are those devices for which general controls by 
themselves are insufficient to provide reasonable assurance of safety 
and effectiveness, but for which there is sufficient information to 
establish special controls to provide such assurance, including the 
promulgation of performance standards, postmarket surveillance, patient 
registries, development and dissemination of guidelines, 
recommendations, and other appropriate actions the Agency deems 
necessary to provide such assurance (section 513(a)(1)(B) of the FD&C 
Act). Class III devices are those devices for which insufficient 
information exists to determine that general controls and special 
controls would provide a reasonable assurance of safety and 
effectiveness, and are purported or represented for a use in supporting 
or sustaining human life or for a use which is of substantial 
importance in preventing impairment of human health, or present a 
potential unreasonable risk of illness or injury (section 513(a)(1)(C) 
of the FD&C Act).
    Under section 513(d)(1) of the FD&C Act, devices that were in 
commercial distribution before the enactment of the 1976 amendments, 
May 28, 1976 (generally referred to as ``preamendments devices''), are 
classified after FDA: (1) Receives a recommendation from a device 
classification panel (an FDA advisory committee); (2) publishes the 
panel's recommendation, along with a proposed regulation classifying 
the device, and provides an opportunity for interested persons to 
submit comments; and (3) publishes a final regulation classifying the 
device.
    FDA has classified most preamendments devices under these 
procedures, relying upon valid scientific evidence as described in 
section 513(a)(3) of the FD&C Act and 21 CFR 860.7(c), to determine 
that there is reasonable assurance of the safety and effectiveness of a 
device under its conditions of use.
    Devices that were not in commercial distribution before May 28, 
1976 (generally referred to as ``postamendments devices''), are 
classified automatically by section 513(f) of the FD&C Act into class 
III without any FDA rulemaking process. Those devices remain in class 
III and require premarket approval, unless and until: (1) FDA 
classifies or reclassifies the device into class I or II or (2) FDA 
issues an order finding the device to be substantially equivalent, in 
accordance with section 513(i) of the FD&C Act, to a predicate device 
that does not require premarket approval.
    The Agency determines whether new devices are substantially 
equivalent to previously marketed devices by means of premarket 
notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 
360(k)) and part 807 of the regulations (21 CFR part 807).
    A person may market a preamendments device that has been classified 
into class III through premarket notification procedures without 
submission of a premarket approval application (PMA) until FDA issues a 
final order under section 515(b) of the FD&C Act (21 U.S.C. 360e(b)) 
requiring premarket approval.

A. Need for the Regulation/History of This Rulemaking

    After the enactment of the 1976 amendments, FDA began to identify 
and classify all preamendments devices in accordance with section 
513(b) of the FD&C Act. BECS and BECS accessories are preamendments 
devices. The first BECS 510(k) premarket notification was cleared by 
FDA on August 26, 1996. Information Data Management, Inc., submitted 
premarket notifications for their Components & Distribution Information 
System and Donor Management Information System. These devices were 
compared to systems marketed prior to the 1976 amendments, including 
the Blood Inventory Management System by Computer Sciences Corp. and 
the Donor Deferral Registry developed by the American National Red 
Cross. Between 1996 and the time FDA drafted the proposed rule in 
December 2015, FDA had cleared 220 BECS and BECS accessories under the 
510(k) program. BECS and BECS accessories are regulated under product 
code MMH.
    In 1998, FDA sought recommendations from the BPAC, serving as a 
Device Classification Panel, on the classification of BECS. The Device 
Classification Panel recommended regulating BECS as a class II device 
with premarket review (Ref. 1). The classification of BECS was not 
finalized following the Device Classification Panel's recommendation in 
1998 because of competing priorities.
    On December 3, 2014, the BPAC, serving as a Device Classification 
Panel (the Panel), again convened to discuss the classification of BECS 
and BECS accessories (Ref. 2). The Panel discussed the risks to health 
associated with BECS and BECS accessories, the classification of BECS 
and BECS accessories, and, if classified as class II devices, the 
special controls that would be required for these devices. The Panel 
agreed that general controls were not sufficient to provide a 
reasonable assurance of safety and effectiveness of BECS and BECS 
accessories. The Panel believed that BECS and BECS accessories 
presented a potential unreasonable risk of illness, injury, or death, 
and that sufficient information exists to establish special controls 
for these devices.

[[Page 23214]]

Consequently, the Panel recommended that these devices be classified 
into class II (special controls) with premarket review.
    After considering the recommendations of the Panel and the valid 
scientific evidence, including the published literature, medical device 
reports, recall information, and FDA's extensive inspection and 
regulatory experiences with these device types (Ref. 3), FDA published 
a proposed rule in the Federal Register of March 1, 2016 (81 FR 10553), 
to classify BECS and BECS accessories into class II (special controls) 
with premarket review. In the proposed rule, FDA identified the risks 
to health and the mitigation measures for BECS and BECS accessories. 
FDA assessed the risks to health for BECS accessories and found these 
risks to be the same as BECS and, therefore, proposed to classify the 
BECS as the parent device and BECS accessories together. FDA is not 
aware of any new information that has arisen since this Panel meeting 
and the publication of the proposed rule that would provide a basis for 
different recommendations or findings. FDA believes general controls by 
themselves are insufficient to provide reasonable assurance of safety 
and effectiveness for these devices and that there is sufficient 
information to establish special controls to provide such assurance. 
FDA believes that special controls, in addition to general controls, 
would provide a reasonable assurance of the safety and effectiveness of 
BECS and BECS accessories and would, therefore, mitigate risks as 
summarized in table 1.

     Table 1--Health Risks and Mitigation Measures for BECS and BECS
                               Accessories
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        Identified risks to health               Mitigation measures
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Transfusion reaction or death.............  Performance and functional
                                             requirements.
Transmission of infectious disease........  Performance and testing.
Donor health risk from too frequent or      Labeling.
 inappropriate donation.
------------------------------------------------------------------------

    The special controls that were proposed for BECS and BECS 
accessories--specifically performance and functional requirements, 
device verification and validation, hazard analysis, traceability 
matrix, performance testing, and labeling--collectively ensure that the 
manufacturer performs and documents the activities necessary to 
decrease the risk of malfunction that could result in adverse events. 
Further, appropriate labeling ensures that the user of the device is 
provided clear instructions for use, including the limitations of the 
device, to reduce the risk of user error that could result in the risks 
to health associated with these devices.
    Section 510(m) of the FD&C Act provides that a class II device may 
be exempted from the premarket notification requirements under section 
510(k) of the FD&C Act, if the Agency determines that premarket 
notification is not necessary to assure the safety and effectiveness of 
the device. The Agency does not intend to exempt BECS and BECS 
accessories from 510(k) premarket notification as allowed under section 
510(m) of the FD&C Act. FDA believes premarket notification is 
necessary for these devices to assure their safety and effectiveness.

B. Summary of Comments to the Proposed Rule

    Most of the comments expressed support for the proposed rule and 
agreed with the proposed classification of BECS and BECS accessories as 
class II devices and the proposed special controls. Two commenters 
disagreed with the proposed classification of BECS and BECS accessories 
into class II. Several comments requested clarification of the 
definition of BECS accessory. Several commenters requested 
clarification on the proposed special controls.

III. Legal Authority

    We are issuing this final rule under section 513(a)(1)(B) of the 
FD&C Act. FDA has the authority under this provision of the FD&C Act to 
issue a regulation to establish special controls for class II devices 
for which general controls by themselves are insufficient to provide 
reasonable assurance of safety and effectiveness, but there is 
sufficient information to establish special controls to provide such 
assurance. Under this authority, FDA is establishing special controls 
for the class II devices for BECS and BECS accessories.

IV. Comments on the Proposed Rule and FDA Response

A. Introduction

    In response to the proposed rule (81 FR 10553) to classify BECS and 
BECS accessories into class II, we received seven comment letters by 
the close of the comment period, each containing one or more comments 
on one or more issues. We received comments from a blood establishment, 
two trade organizations representing the blood and plasma industries, 
one device manufacturer, one anonymous response, one private citizen, 
and one public health research organization.
    We describe and respond to the comments in section IV.B. We have 
numbered each comment to help distinguish between different comments. 
We have grouped similar comments together under the same number, and, 
in some cases, we have separated different issues discussed in the same 
comment and designated them as distinct comments for purposes of our 
responses. The number assigned to each comment or comment topic is 
purely for organizational purposes and does not signify the comment's 
value or importance or the order in which comments were received.

B. Specific Comments and FDA Response

    (Comment 1) One comment suggested that FDA has failed to establish 
that BECS and BECS accessories present an ``unreasonable'' risk of 
illness or injury.
    (Response 1) We disagree. As presented to the Panel on December 3, 
2014, in the 1990s during establishment inspection observations, it was 
revealed that unsuitable blood and blood components had been released 
and distributed as a result of improperly designed software. This posed 
potential unreasonable risks to health such as transfusion reaction, 
injury or death, and transmission of infectious disease. These 
observations resulted in warning letters and recalls of the unsuitable 
blood and blood components, as well as warning letters and recalls of 
the defective software. Furthermore, as BECS programs became 
increasingly complex, FDA investigators found that validation solely by 
the end user of the device was proving impractical, and was 
insufficient to assure software performance. Therefore, FDA determined 
that there were potential unreasonable risks to health associated with 
BECS and convened the Panel in December 2014. The Panel considered the 
scientific evidence presented at the meeting and recommended that BECS 
and BECS accessories be classified into

[[Page 23215]]

class II (special controls) with premarket review. After considering 
the recommendations of the Panel and the valid scientific evidence, 
including the published literature, medical device reports, recall 
information, and FDA's extensive inspection and regulatory experiences 
with these device types (Ref. 3), FDA proposed that BECS and BECS 
accessories be classified into class II (special controls) with 
premarket review. In the proposed rule, FDA proposed that special 
controls, in addition to general controls, would provide a reasonable 
assurance of the safety and effectiveness of BECS and BECS accessories 
and would, therefore, mitigate the risks to patients of transfusion 
reaction or death and transmission of infectious disease and risks to 
donors because of inappropriate donations. FDA is not aware of any new 
information that has arisen since this Panel meeting and the 
publication of the proposed rule that would provide a basis for 
different recommendations or findings. Accordingly, this final rule 
classifies BECS and BECS accessories into class II (special controls) 
with premarket review.
    (Comment 2) One comment recommended that the rule should detail the 
requirements for verification and validation.
    (Response 2) The final rule includes verification and validation 
testing as a special control. FDA issued the guidance entitled 
``General Principles of Software Validation; Final Guidance for 
Industry and FDA Staff'' on January 11, 2002, which outlines general 
validation principles and recommendations that are considered 
applicable to the validation of medical device software, or the 
validation of software used to design, develop, or manufacture medical 
devices (Ref. 4). BECS manufacturers can follow the recommendations in 
this guidance to help ensure appropriate validation testing of their 
device. FDA believes that the recommendations in this guidance support 
the requirements in the Quality System Regulation (21 CFR part 820), 
and can assist manufacturers in meeting the requirements for 
verification and validation testing as a special control.
    (Comment 3) Multiple comments requested clarification of the 
definition of BECS accessories.
    (Response 3) FDA agrees that clarification of BECS accessories is 
needed. To provide greater clarity we have revised the identification 
language in the classification regulation. Under the final rule, a BECS 
accessory is defined as a device intended for use with BECS to augment 
its performance or to expand or modify its indications for use. In 
response to comments, we are providing examples of BECS accessories.
    The following examples are BECS accessories:
     A software device that queries a BECS to find blood 
components and donors that meet specific requirements, e.g., Human 
Leukocyte Antigen and Cytomegalovirus status and allows the selections 
of the most suitable blood component for the recipient and, in doing 
so, expands the indications for use of the BECS.
     A software device that augments the performance and 
expands the indications for use of the BECS by providing biometric 
technology to identify a blood donor.
     A software device that augments the performance of the 
BECS by providing algorithms for donor or transfusion management.
    The following examples are not BECS accessories:
     An interface that merely transmits data from an external 
device to the BECS such as billing information or inventory information 
to stock units in the blood bank is not a BECS accessory. These 
functionalities are not related to the indications for use of a BECS 
and do not alter the data of the BECS; thus, such an interface would 
not meet the definition of a BECS accessory.
     An interface from a blood pressure device to the BECS that 
performs a straight transfer of blood pressure information but does not 
modify the medical data before or during the transfer is not a BECS 
accessory. The data transfer itself does not expand the indications for 
use of the BECS; it merely transfers data without manipulation of the 
data or addition of logic function. Thus, it would not meet the 
definition of a BECS accessory.
     An interface between two BECS systems that is a straight 
transfer of information and where the interface software does not 
modify the medical data before or during the transfer does not meet the 
definition of a BECS accessory because it is not used to augment the 
performance of the BECS or to expand or modify its indications for use.
     An interface that merely transfers data from the BECS to 
another device simply for donor appointments is not a BECS accessory. 
It does not meet the definition of a BECS accessory because it is not 
used to augment the performance of the BECS or to expand or modify its 
indications for use (it is simply transferring data from the BECS).
    (Comment 4) One comment recommended that we distinguish a BECS 
accessory from Medical Device Data Systems (MDDS).
    (Response 4) A BECS accessory is a device used with BECS to augment 
the performance or expand or modify the indications for use of the 
BECS. Like BECS, BECS accessories are not MDDS because they are 
intended to do more than simply transfer, store, or display medical 
device data or convert medical device data from one format to another 
format in accordance with a preset specification.
    Section 3060 of the 21st Century Cures Act (Cures Act), Pub. L. 
114-255 (2016), amended the FD&C Act to add section 520(o) (21 U.S.C. 
360j(o)), which describes certain software functions, including 
functions performed by MDDS, that are excluded from the definition of 
device in section 201(h) of the FD&C Act (21 U.S.C. 321(h)). Section 
3060 of the Cures Act further states that section 520(o) of the FD&C 
Act shall not be construed to limit FDA's authority to regulate 
software used in the manufacture and transfusion of blood and blood 
components to assist in the prevention of disease in humans. Therefore, 
BECS and BECS accessories are not covered by section 520(o)(1)(D) of 
the FD&C Act, and FDA regulates BECS and BECS accessories as devices.
    (Comment 5) One comment asked if software intended for the 
maintenance of data that blood establishments use in making decisions 
regarding the suitability of donors and the release of blood components 
for transfusion or further manufacture would be classified as BECS.
    (Response 5) Software that uses the stored data for the purposes of 
identifying ineligible donors, preventing the release of unsuitable 
blood and blood components for transfusion or for further manufacture, 
performing compatibility testing between donor and recipient, or 
performing positive identification of patients and blood components at 
the point of transfusion would meet the definition of BECS. Software 
intended for electronic storage of medical data without interpreting or 
analyzing the data or altering the functions or parameters of any 
connected medical device would not meet the definition of BECS.
    (Comment 6) One comment stated that the definition of BECS does not 
cover middleware applications used to send data from a device used in 
blood collection centers to a Donor Management System and asked for 
clarification regarding the regulation of such products.
    (Response 6) Middleware applications that only transfer medical 
data from one medical device to another medical

[[Page 23216]]

device and do not augment the performance or expand or modify the 
indications for use of the BECS would not meet the definition of a BECS 
accessory.
    (Comment 7) One comment questioned whether beta testing should be 
included as a special control.
    (Response 7) The final regulation includes verification and 
validation testing as a special control. Verification and validation 
testing should include beta testing which can be performed in a user 
environment or simulated user environment.
    The guidance document entitled ``General Principles of Software 
Validation; Final Guidance for Industry and FDA Staff'' issued January 
11, 2002 (Ref. 4), provides recommendations on software validation.
    (Comment 8) One comment asked FDA to clarify its expectations with 
respect to the development and presentation of a traceability matrix.
    (Comment 8) FDA has provided recommendations for developing a 
traceability matrix in the document entitled, ``Guidance for Industry 
and FDA Staff: Guidance for the Content of Premarket Submissions for 
Software Contained in Medical Devices,'' issued May 11, 2005 (Ref. 5).
    (Comment 9) One comment recommended we review BECS and BECS 
accessories through the PMA (class III) approval process since there 
have been injuries and deaths associated with these devices. The 
comment also stated that there is not sufficient information to 
establish class II special controls for the devices.
    (Response 9) Although BECS and BECS accessories are currently 
unclassified, FDA has regulated these devices for more than 20 years, 
and during this time period, FDA has applied standards for class II 
devices in reviewing 510(k)s for these devices. No deaths or serious 
injuries have been attributed to the malfunction of the device. As 
described in FDA's Executive Summary to the BPAC meeting of December 3, 
2014 (Ref. 3), valid scientific evidence, including the published 
literature, medical device reports, recall information, and FDA's 
extensive inspection and regulatory experiences with these device 
types, supports classifying BECS and BECS accessories into Class II 
with special controls. After considering this evidence, the Panel 
recommended classification of BECS and BECS accessories as a Class II 
device with special controls. After considering the recommendations of 
the Panel and the valid scientific evidence, FDA proposed that BECS and 
BECS accessories be classified into class II (special controls) with 
premarket review. In the proposed rule, FDA proposed that special 
controls, in addition to general controls, would provide a reasonable 
assurance of the safety and effectiveness of BECS and BECS accessories 
and would, therefore, mitigate the risks to patients of transfusion 
reaction or death and transmission of infectious disease and risks to 
donors because of inappropriate donations. FDA is not aware of any new 
information that has arisen since this Panel meeting and the 
publication of the proposed rule that would provide a basis for 
different recommendations or findings. Accordingly, this final rule 
classifies BECS and BECS accessories into class II (special controls) 
with premarket review. For additional information on premarket 
submissions, please refer to the following guidance documents: 
``Guidance for Industry and FDA Staff: Guidance for the Content of 
Premarket Submissions for Software Contained in Medical Devices,'' 
issued May 11, 2005 (Ref. 5), and ``Deciding When to Submit a 510(k) 
for a Software Change to an Existing Device: Guidance for Industry and 
FDA Staff,'' issued October 25, 2017 (Ref. 6).
    (Comment 10) One comment stated that the proposed rule lacked a 
cost/benefit discussion on the proposed classification.
    (Response 10) Sections I.D. and VI. of this rule discusses FDA's 
economic analysis of impacts of the final rule. As discussed in the 
proposed rule and in sections I.D. and VI. of this final rule, under 
current practice, manufacturers already conform to the special controls 
for BECS and BECS accessories. This rule would essentially formalize 
current practice, and will not result in any additional associated 
costs or benefits.
    (Comment 11) One comment stated that the Center for Devices and 
Radiological Health in FDA has identified Sanguin Medusa 2000 with the 
product code MMH; and it is listed as being cleared September 29, 1994, 
which predates the first FDA cleared 510(k) for BECS identified in the 
proposed rule.
    (Response 11) While this comment is outside the scope of the 
proposed rule, we appreciate the comment and will ensure that proper 
product codes are assigned to this product, which is not a BECS or BECS 
accessory.

V. Effective Date

    This final rule will become effective 30 days after its publication 
in the Federal Register.

VI. Economic Analysis of Impacts

    We have examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, Executive Order 13771, the 
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded 
Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 
13563 direct us 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). Executive Order 13771 
requires that the costs associated with significant new regulations 
``shall, to the extent permitted by law, be offset by the elimination 
of existing costs associated with at least two prior regulations.'' We 
believe that this final rule is not a significant regulatory action as 
defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because this rule is consistent with historical regulatory 
oversight given to this type of device, and would not impose any 
additional regulatory burdens, we certify that the final rule will not 
have a significant economic impact on a substantial number of small 
entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before issuing ``any rule that includes 
any Federal mandate that may result in the expenditure by State, local, 
and tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more (adjusted annually for inflation) in any one 
year.'' The current threshold after adjustment for inflation is $148 
million, using the most current (2016) Implicit Price Deflator for the 
Gross Domestic Product. This final rule would not result in an 
expenditure in any year that meets or exceeds this amount.
    This rule classifies BECS and BECS accessories into class II 
devices with special controls and subject to premarket review. The 
special controls for these devices are necessary to provide a 
reasonable assurance of safety and effectiveness. Between 1996 and the 
time that FDA drafted the proposed rule in December 2015, FDA had 
cleared 220 BECS and BECS accessories under the 510(k) program, 
consistent with the recommendations in the FDA guidance, ``Guidance for 
Industry and FDA Staff;

[[Page 23217]]

Guidance for the Content of Premarket Submissions for Software 
Contained in Medical Devices,'' issued May 11, 2005 (Ref. 5). As 
current practice, manufacturers already conform to the recommended 
controls for BECS and BECS accessories. This rule would essentially 
formalize current practice and will not result in any additional 
associated costs. Likewise, this classification will not result in any 
significant changes in how premarket notifications for the affected 
devices are submitted or prepared by manufacturers or in how they are 
reviewed by FDA. Therefore, compliance with the special controls for 
this device would not yield significant new costs for affected 
manufacturers. Because the classification of these devices to class II 
(special controls) would not impose significant new obligations on 
manufacturers, the Agency concludes that the rule will impose no 
additional regulatory burdens.

VII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.34(b) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VIII. Paperwork Reduction Act of 1995

    This final rule refers to previously approved collections of 
information that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 
3501-3520). The collections of information in 21 CFR part 807, subpart 
E, have been approved under OMB control number 0910-0120, and the 
collections of information in 21 CFR part 801 have been approved under 
OMB control number 0910-0485.

IX. Federalism

    We have analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. We have determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, we conclude that the rule 
does not contain policies that have federalism implications as defined 
in the Executive Order and, consequently, a federalism summary impact 
statement is not required.

X. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this rule in accordance with the principles set 
forth in Executive Order 13175. We have determined that the rule does 
not contain policies that have substantial direct effects on one or 
more Indian Tribes, on the relationship between the Federal Government 
and Indian Tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian Tribes. Accordingly, we 
conclude that the rule does not contain policies that have tribal 
implications as defined in the Executive Order and, consequently, a 
tribal summary impact statement is not required.

XI. References

    The following references are on display in the Dockets Management 
Staff (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m. Monday through Friday. FDA has 
verified the website addresses, as of the date this document publishes 
in the Federal Register, but websites are subject to change over time.

1. Blood Products Advisory Committee Meeting transcript, March 20, 
1998 (http://www.fda.gov/ohrms/dockets/ac/98/transcpt/3391t2.pdf).
2. Blood Products Advisory Committee Meeting transcript, December 3, 
2014 (https://wayback.archive-it.org/7993/20170111180042/http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/ucm386681.htm).
3. FDA Executive Summary. Blood Products Advisory Committee Meeting, 
December 3, 2014 (https://wayback.archive-it.org/7993/20170111180042/ http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/ucm386681.htm).
4. General Principles of Software Validation; Final Guidance for 
Industry and FDA Staff, January 11, 2002 (https://www.fda.gov/downloads/MedicalDevices/.../ucm085371.pdf).
5. Guidance for Industry and FDA Staff: Guidance for the Content of 
Premarket Submissions for Software Contained in Medical Devices, May 
11, 2005 (https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm089593.pdf).
6. Deciding When to Submit a 510(k) for a Software Change to an 
Existing Device: Guidance for Industry and FDA Staff, October 25, 
2017 (https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm514737.pdf).

List of Subjects in 21 CFR Part 864

    Blood, Medical devices, Packaging and containers.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
864 is amended as follows:

PART 864--HEMATOLOGY AND PATHOLOGY DEVICES

0
1. The authority citation for part 864 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  864.9165 to subpart J to read as follows:

Sec.  864.9165   Blood establishment computer software and accessories.

    (a) Identification. Blood establishment computer software (BECS) is 
a device used in the manufacture of blood and blood components to 
assist in the prevention of disease in humans by identifying ineligible 
donors, by preventing the release of unsuitable blood and blood 
components for transfusion or for further manufacturing into products 
for human treatment or diagnosis, by performing compatibility testing 
between donor and recipient, or by performing positive identification 
of patients and blood components at the point of transfusion to prevent 
transfusion reactions. This generic type of device may include a BECS 
accessory, a device intended for use with BECS to augment the 
performance of the BECS or to expand or modify its indications for use.
    (b) Classification. Class II (special controls). The special 
controls for these devices are:
    (1) Software performance and functional requirements including 
detailed design specifications (e.g., algorithms or control 
characteristics, alarms, device limitations, and safety requirements).
    (2) Verification and validation testing and hazard analysis must be 
performed.
    (3) Labeling must include:
    (i) Software limitations;
    (ii) Unresolved anomalies, annotated with an explanation of the 
impact on safety or effectiveness;
    (iii) Revision history; and
    (iv) Hardware and peripheral specifications.
    (4) Traceability matrix must be performed.
    (5) Performance testing to ensure the safety and effectiveness of 
the system must be performed, including when adding new functional 
requirements (e.g., electrical safety, electromagnetic compatibility, 
or wireless coexistence).

[[Page 23218]]

    Dated: May 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10610 Filed 5-17-18; 8:45 am]
 BILLING CODE 4164-01-P