
[Federal Register Volume 81, Number 40 (Tuesday, March 1, 2016)]
[Proposed Rules]
[Pages 10553-10557]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04411]



[[Page 10553]]

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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: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
proposing to classify the blood establishment computer software (BECS) 
and BECS accessories into class II (special controls). FDA is 
identifying proposed 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 (the FD&C 
Act). FDA is publishing in this document the recommendations of the 
Blood Product Advisory Committee regarding the classification of these 
devices. After considering public comments on the proposed 
classification, FDA will publish a final regulation classifying these 
device types.

DATES: Submit either electronic or written comments by May 31, 2016. 
Please see section IV of this document for the proposed effective date 
of a final rule that may issue based on this proposal.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-N-0406 for ``Medical Devices; Hematology and Pathology 
Devices; Classification of Blood Establishment Computer Software and 
Accessories.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at http://www.regulations.gov or at the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jessica T. Walker, 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: 

I. Background

A. Statutory and Regulatory Authorities

    The FD&C Act (21 U.S.C. 301 et seq.), as amended by the Medical 
Device Amendments of 1976, establishes a comprehensive system for the 
regulation of medical devices intended for human use. Section 513 of 
the FD&C Act (21 U.S.C. 360c) 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; 
or 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

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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 
issue 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 Medical Device 
Amendments of 1976 (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 for 
comment, along with a proposed regulation classifying the device; 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.

B. Regulatory History of the Devices

    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.
    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 medical device amendments, including 
the Blood Inventory Management System by Computer Sciences Corporation 
and the Donor Deferral Registry developed by the American National Red 
Cross. Between 1996 and December 2015, FDA has cleared 220 BECS and 
BECS accessories under the 510(k) program.
    In 1998, FDA sought recommendations from the Blood Product Advisory 
Committee (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. Consequently, the Panel recommended that these 
devices be classified into class II (special controls) with premarket 
review. FDA is not aware of new information that has arisen since this 
Panel meeting that would provide a basis for different recommendations 
or findings. The recommendations of the Panel are summarized in Section 
II.

II. Panel Recommendation

    This section summarizes the Panel's deliberations on December 3, 
2014.

A. Identification

    FDA proposed the following definition of BECS and BECS accessory to 
the Panel for their consideration: BECS and BECS accessories are 
devices used in the manufacture of blood and blood components to assist 
in the prevention of disease in humans by identifying unsuitable blood 
donors by: (1) Preventing the release of unsuitable blood and blood 
components for transfusion or for further manufacturing into products 
for human treatment or diagnosis; (2) performing compatibility testing 
between donor and recipient; and (3) performing positive identification 
of patients and blood components. A BECS accessory expands or modifies 
the function of the BECS and/or indications for use of the BECS device. 
These devices are intended for use with or capable of functioning with 
BECS for the purpose of augmenting or supplementing the BECS 
performance.

B. Recommended Classification of the Panel

    The Panel recommended that BECS and BECS accessories be classified 
into class II (special controls) with premarket review, and that FDA 
revise the proposed definition of a BECS accessory. The consensus of 
the Panel was that class II classification (special controls) and 
premarket review would provide reasonable assurance of safety and 
effectiveness of these devices and that there is sufficient information 
to establish special controls to provide such assurance for BECS and 
BECS accessories.
    The Panel considered the following valid scientific evidence to 
make their recommendations regarding the safety and effectiveness of 
the device under its conditions of use. Specifically, the Panel 
considered the history of safety and effectiveness of BECS and BECS 
accessories over many years of use in

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blood establishments; the results of an FDA review of the scientific 
literature; medical device reports (MDRs) of adverse events or 
malfunctions; device recalls; and a summary of FDA's extensive 
inspectional and regulatory experiences with BECS and BECS accessories.
    The Panel also commented on the proposed definition of BECS 
accessories: ``A BECS accessory expands or modifies the function of the 
BECS and/or indications for use of the BECS device.'' These devices are 
intended for use with or capable of functioning with BECS for the 
purpose of augmenting or supplementing the BECS performance. The Panel 
recommended that FDA clarify which added functionalities would be 
considered a BECS accessory and, therefore, subject to regulations as a 
class II device with special controls.

C. Risks to Health and Special Controls

    As required by section 513(f)(1)(A) of the FD&C Act, FDA provided 
to the Panel the following summary of valid scientific evidence 
regarding the benefits and risks of BECS and BECS accessories. In the 
1990s, during establishment inspections, FDA investigators observed 
numerous problems with BECS, including software programs that posed 
significant risks to health, such as the potential for release for 
transfusion of blood and blood components found to be reactive when 
tested with assays for Human Immunodeficiency Virus. During the 
inspections, FDA found that unsuitable blood and blood components had 
been released and distributed as a result of improperly designed 
software.
    From 1996 to 2014, FDA received 201 MDRs for BECS and BECS 
accessories. The majority (86 percent) of the MDRs were for device 
malfunctions. In addition, one death and nine injuries were reported. 
The reported patient death was not attributed to the BECS. The 
information provided in the reports of the nine injuries was 
insufficient to accurately identify the nature of the injuries or the 
attribution to BECS. The remaining reports included events classified 
in various categories such as user error, operational problems, and 
labeling.
    Similarly, from 2006 to 2013, BECS manufacturers initiated 56 
voluntary device recalls. The deviations included programming errors, 
inadequate design requirements, and incorrect implementation of the 
design. The potential consequences of the BECS deviations included 
presenting donors with incorrect donor history questionnaires, failing 
to save certain test results in donor records, and failing to identify 
donors as deferred. The recalls were classified as class II and class 
III. A class II recall is a situation in which use of or exposure to a 
violative product may cause temporary or medically reversible adverse 
health consequences or where the probability of serious adverse health 
consequences is remote. A class III recall is a situation in which use 
of or exposure to a violative product is not likely to cause adverse 
health consequences. No recalls were classified as class I, a situation 
in which there is reasonable probability that the use of or exposure to 
a violative product will cause serious adverse health consequences or 
death.
    FDA presented the following risks to health associated with BECS 
and BECS accessories: (1) Transfusion reaction or death from the 
inadvertent release and transfusion of incompatible blood or blood 
components; (2) transfusion injury from the transfusion of inaccurately 
labeled and/or stored blood components; (3) transfusion injury or death 
from the release of blood components from otherwise ineligible donors 
(for example, the transmission of infectious diseases from the 
inadvertent release of blood components that have tested positive for 
transfusion-transmitted disease agents); and (4) donor injury from 
inappropriate or excessive donation of blood or blood components.
    FDA also proposed the measures described in table 1 to mitigate the 
risks to health associated with BECS and BECS accessories. The Panel 
agreed that the risks to health and mitigation measures identified by 
FDA and summarized in table 1 are applicable to BECS and BECS 
accessories.
    FDA next presented the following special controls for the Panel's 
considerations: (1) Software performance and functional requirements 
are provided in the premarket submission including detailed design 
specifications (e.g., algorithms or control characteristics, alarms, 
device limitations, and safety requirements); (2) verification and 
validation testing and hazard analysis are to be performed and provided 
in the premarket submission; (3) labeling includes software 
limitations, unresolved anomalies, annotated with an explanation of the 
impact on safety or effectiveness, revision history, and hardware and 
peripheral specifications; (4) traceability matrix performed and 
provided in the premarket submission; and (5) performance testing is 
performed and provided in the premarket submission, as necessary to 
ensure the safety and effectiveness of the system, and when adding new 
functional requirements, (e.g., electrical safety, electromagnetic 
compatibility, or wireless coexistence).
    The Panel members generally agreed with the special controls 
proposed by FDA. One Panel member commented that requiring the 
performance of verification and validation and hazard analysis is not 
sufficient without defining what type of testing is necessary, and 
expressed particular concern regarding the acceptable level of 
verification for BECS. Another member asked whether many of the 
proposed special controls should be considered general controls for the 
purposes of software manufacturing considering the evolution of 
technology.

     Table 1--Health Risks and Mitigation Measures for BECS and BECS
                               Accessories
------------------------------------------------------------------------
        Identified risks to health               Mitigation measures
------------------------------------------------------------------------
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.
------------------------------------------------------------------------

III. Proposed Classification and FDA's Findings

    After considering the recommendations of the Panel and the valid 
scientific evidence, including the published literature, MDRs, recall 
information, and FDA's extensive inspection and regulatory experiences 
with these device types (Ref. 3), FDA proposes to classify BECS and 
BECS accessories into class II (special controls) with premarket 
review. 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 the risk to patients of transfusion reaction or 
death and transmission of infectious disease and risks to donors 
because of inappropriate donations.
    The special controls proposed for BECS and BECS accessories, 
specifically performance and functional requirements, device 
verification and validation, hazards analysis,

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traceability, and performance testing, collectively ensure that the 
manufacturer performs and documents the activities necessary to 
decrease the risk of malfunction that could result in the adverse 
events noted above. 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.
    FDA has amended the proposed definition of BECS accessories 
consistent with the recommendation of the Panel and made other minor 
edits to the definition of BECS and the special controls presented to 
the Panel in the proposed regulation.
    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.

IV. Proposed Effective Date

    FDA proposes that any final regulation based on this proposal 
become effective 30 days after its date of publication in the Federal 
Register.

V. 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.

VI. Analysis of Impacts

    We have examined the impacts of the proposed rule under Executive 
Order 12866, Executive Order 13563, 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). We 
believe that this proposed rule is not a significant regulatory action 
as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because the proposed regulation is consistent with 
historical regulatory oversight given to this type of device, we 
propose to certify that the proposed 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 proposing ``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 $144 million, using the most current (2014) Implicit 
Price Deflator for the Gross Domestic Product. This proposed rule would 
not result in an expenditure in any year that meets or exceeds this 
amount.
    This rule proposes to classify BECS and BECS accessories into Class 
II devices with special controls and subject to premarket review. The 
proposed special controls for these devices are necessary to provide a 
reasonable assurance of safety and effectiveness. FDA has cleared 220 
BECS and BECS accessories under the 510(k) program consistent with the 
recommendations in the FDA guidance, ``Guidance for the Content of 
Premarket Submissions for Software Contained in Medical Devices,'' 
dated May 2005 (Ref. 4). As current practice, manufacturers already 
conform to the risk mitigations that are being proposed as special 
controls for BECS and BECS accessories, so 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 510(k) 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 proposed 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 proposed 
rule, if finalized, will impose no additional regulatory burdens.

VII. Paperwork Reduction Act

    This proposed 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 subpart 801 have been approved 
under OMB control number 0910-0485. Therefore, FDA tentatively 
concludes that the proposed requirements in this document are not 
subject to review by OMB because they do not constitute a ``new 
collection of information'' under the PRA.

VIII. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday; 
they are also available electronically at http://www.regulations.gov. 
FDA has verified the Web site addresses, as of the date this document 
publishes in the Federal Register, but Web sites are subject to change 
over time.

1. Blood Product Advisory Committee Meeting transcript--March 20, 
1998 (http://www.fda.gov/ohrms/dockets/ac/98/transcpt/3391t2.pdf).
2. Blood Product Advisory Committee Meeting transcript--December 3, 
2014 (http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/ucm386681.htm).
3. FDA Executive Summary. Blood Products Advisory Committee 
Meeting--December 3, 2014 (http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/ucm427392.htm).
4. Guidance for Industry and FDA Staff: Guidance for the Content of 
Premarket Submissions for Software Contained in Medical Devices, May 
2005, http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm089543.htm.

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, FDA proposes 
to amend part 864 as follows:

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PART 864--HEMATOLOGY AND PATHOLOGY DEVICES

0
1. The authority citation for 21 CFR part 864 continues to read as 
follows:

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

0
2. In subpart J, add Sec.  864.9165 to read as follows:


Sec.  864.9165  Blood establishment computer software and accessories.

    (a) Identification. Blood establishment computer software (BECS) 
and BECS accessories are devices 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. A BECS accessory is 
intended for use with BECS to augment its performance 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).

    Dated: February 24, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04411 Filed 2-29-16; 8:45 am]
BILLING CODE 4164-01-P


