Medical Devices; Hematology and Pathology Devices; Classification of the Whole Slide Imaging System, 20-22 [2017-28262]

Download as PDF 20 Federal Register / Vol. 83, No. 1 / Tuesday, January 2, 2018 / Rules and Regulations 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 objections. The second copy, which will have the claimed confidential information redacted/ blacked out, will be available for public viewing and posted on https:// www.regulations.gov. Submit both copies to the Dockets Management Staff. 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 objections 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: https://www.fda.gov/ regulatoryinformation/dockets/ default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper objections received, go to https:// 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Chelsea Trull, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–402–6729, chelsea.trull@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background daltland on DSKBBV9HB2PROD with RULES In a document published in the Federal Register of May 30, 2017 (82 FR 24611), FDA announced that we had filed a food additive petition (animal use) (FAP 2301) submitted by BASF Corp., 100 Park Ave., Florham Park, NJ 07932. The petition proposed that the regulations for food additives permitted in feed and drinking water of animals be amended to provide for the safe use of formic acid as a feed acidifying agent in complete poultry feeds. II. Conclusion FDA concludes that the data establish the safety and utility of formic acid as an acidifying agent in complete poultry feeds and that the food additive regulations should be amended as set VerDate Sep<11>2014 21:22 Dec 29, 2017 Jkt 244001 forth in this document. This is not a significant regulatory action subject to Executive Order 12866. PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS III. Public Disclosure ■ In accordance with § 571.1(h) (21 CFR 571.1(h)), the petition and documents we considered and relied upon in reaching our decision to approve the petition will be made available for public disclosure (see FOR FURTHER INFORMATION CONTACT). As provided in § 571.1(h), we will delete from the documents any materials that are not available for public disclosure. IV. Environmental Impact The Agency has determined under 21 CFR 25.32(r) 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. V. Objections and Hearing Requests Any person who will be adversely affected by this regulation may file with the Dockets Management Staff (see ADDRESSES) either electronic or written objections. Each objection shall be separately numbered, and each numbered objection shall specify with particularity the provision of the regulation to which objection is made and the grounds for the objection. Each numbered objection on which a hearing is requested shall specifically so state. Failure to request a hearing for any particular objection shall constitute a waiver of the right to a hearing on that objection. Each numbered objection for which a hearing is requested shall include a detailed description and analysis of the specific factual information intended to be presented in support of the objection in the event that a hearing is held. Failure to include such a description and analysis for any particular objection shall constitute a waiver of the right to a hearing on the objection. Any objections received in response to the regulation may be seen in the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov. List of Subjects in 21 CFR Part 573 Animal feeds, Food additives. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 573 is amended as follows: PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 1. The authority citation for part 573 continues to read as follows: Authority: 21 U.S.C. 321, 342, 348. 2. In § 573.480, revise paragraph (b) introductory text and paragraph (b)(5)(iii)(B) to read as follows: ■ § 573.480 Formic acid. * * * * * (b) The additive is used or intended for use as a feed acidifying agent, to lower the pH, in complete swine and poultry feeds at levels not to exceed 1.2 percent of the complete feed. * * * * * (5) * * * (iii) * * * (B) Contact address and telephone number for reporting adverse reactions or to request a copy of the Safety Data Sheet (SDS). * * * * * Dated: December 26, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–28251 Filed 12–29–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 864 [Docket No. FDA–2017–N–6780] Medical Devices; Hematology and Pathology Devices; Classification of the Whole Slide Imaging System AGENCY: Food and Drug Administration, HHS. ACTION: Final order. The Food and Drug Administration (FDA or we) is classifying the whole slide imaging system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the whole slide imaging system’s classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens. SUMMARY: E:\FR\FM\02JAR1.SGM 02JAR1 Federal Register / Vol. 83, No. 1 / Tuesday, January 2, 2018 / Rules and Regulations This order is effective January 2, 2018. The classification was applicable on April 12, 2017. FOR FURTHER INFORMATION CONTACT: Steven Tjoe, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4550, Silver Spring, MD 20993–0002, 301–796–5866, steven.tjoe@fda.hhs.gov. SUPPLEMENTARY INFORMATION: DATES: I. Background Upon request, FDA has classified the whole slide imaging system as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients’ access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment. The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as ‘‘postamendments devices’’ because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (see 21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k) and part 807 (21 CFR part 807). FDA may also classify a device through ‘‘De Novo’’ classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105– 115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112–144). A device sponsor may utilize either procedure for De Novo classification. Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act. Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device. We believe this De Novo classification will enhance patients’ access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application in order to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining ‘‘substantial equivalence’’). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device. II. De Novo Classification On December 1, 2016, Philips Medical Systems Nederland B.V. submitted a request for De Novo classification of the Philips IntelliSite Pathology Solution (PIPS). FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act. We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device. Therefore, on April 12, 2017, FDA issued an order to the requester classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 864.3700. We have named the generic type of device the whole slide imaging system, and it is identified as an automated digital slide creation, viewing, and management system intended as an aid to the pathologist to review and interpret digital images of surgical pathology slides. The system generates digital images that would otherwise be appropriate for manual visualization by conventional light microscopy. FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1. TABLE 1—WHOLE SLIDE IMAGING SYSTEM RISKS AND MITIGATION MEASURES daltland on DSKBBV9HB2PROD with RULES Identified risk Mitigation measures/21 CFR Section Inaccurate or missing results leading to, for example, incorrect diagnosis. Delayed results ......................................................................................... VerDate Sep<11>2014 21:22 Dec 29, 2017 Jkt 244001 PO 00000 Frm 00021 Fmt 4700 General controls; Special control (1) Special control (2) General controls; Special control (1) Special control (2) Sfmt 4700 21 (21 CFR 864.3700(b)(1)); and, (21 CFR 864.3700(b)(2)). (21 CFR 864.3700(b)(1)); and, (21 CFR 864.3700(b)(2)). E:\FR\FM\02JAR1.SGM 02JAR1 22 Federal Register / Vol. 83, No. 1 / Tuesday, January 2, 2018 / Rules and Regulations FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act. III. Analysis of Environmental Impact The Agency has 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. IV. Paperwork Reduction Act of 1995 This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations. These collections of information 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 collections of information in the guidance document ‘‘De Novo Classification Process (Evaluation of Automatic Class III Designation)’’ have been approved under OMB control number 0910–0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910–0231; the collections of information in part 21 CFR 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910–0120; and the collections of information in 21 CFR parts 801 and 809, regarding labeling, have been approved under OMB control number 0910–0485. daltland on DSKBBV9HB2PROD with RULES 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 1. The authority citation for part 864 is revised to read as follows: ■ VerDate Sep<11>2014 21:22 Dec 29, 2017 Jkt 244001 Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 2. Add § 864.3700 to subpart D to read as follows: ■ § 864.3700 Whole slide imaging system. (a) Identification. The whole slide imaging system is an automated digital slide creation, viewing, and management system intended as an aid to the pathologist to review and interpret digital images of surgical pathology slides. The system generates digital images that would otherwise be appropriate for manual visualization by conventional light microscopy. (b) Classification. Class II (special controls). The special controls for this device are: (1) Premarket notification submissions must include the following information: (i) The indications for use must specify the tissue specimen that is intended to be used with the whole slide imaging system and the components of the system. (ii) A detailed description of the device and bench testing results at the component level, including for the following, as appropriate: (A) Slide feeder; (B) Light source; (C) Imaging optics; (D) Mechanical scanner movement; (E) Digital imaging sensor; (F) Image processing software; (G) Image composition techniques; (H) Image file formats; (I) Image review manipulation software; (J) Computer environment; and (K) Display system. (iii) Detailed bench testing and results at the system level, including for the following, as appropriate: (A) Color reproducibility; (B) Spatial resolution; (C) Focusing test; (D) Whole slide tissue coverage; (E) Stitching error; and (F) Turnaround time. (iv) Detailed information demonstrating the performance characteristics of the device, including, as appropriate: (A) Precision to evaluate intra-system and inter-system precision using a comprehensive set of clinical specimens with defined, clinically relevant histologic features from various organ systems and diseases. Multiple whole slide imaging systems, multiple sites, and multiple readers must be included. (B) Reproducibility data to evaluate inter-site variability using a comprehensive set of clinical specimens with defined, clinically relevant histologic features from various organ PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 systems and diseases. Multiple whole slide imaging systems, multiple sites, and multiple readers must be included. (C) Data from a clinical study to demonstrate that viewing, reviewing, and diagnosing digital images of surgical pathology slides prepared from tissue slides using the whole slide imaging system is non-inferior to using an optical microscope. The study should evaluate the difference in major discordance rates between manual digital (MD) and manual optical (MO) modalities when compared to the reference (e.g., main sign-out diagnosis). (D) A detailed human factor engineering process must be used to evaluate the whole slide imaging system user interface(s). (2) Labeling compliant with 21 CFR 809.10(b) must include the following: (i) The intended use statement must include the information described in paragraph (b)(1)(i) of this section, as applicable, and a statement that reads, ‘‘It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using this device.’’ (ii) A description of the technical studies and the summary of results, including those that relate to paragraphs (b)(1)(ii) and (iii) of this section, as appropriate. (iii) A description of the performance studies and the summary of results, including those that relate to paragraph (b)(1)(iv) of this section, as appropriate. (iv) A limiting statement that specifies that pathologists should exercise professional judgment in each clinical situation and examine the glass slides by conventional microscopy if there is doubt about the ability to accurately render an interpretation using this device alone. Dated: December 26, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–28262 Filed 12–29–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 878 [Docket No. FDA–2017–N–6596] Medical Devices; General and Plastic Surgery Devices; Classification of the Irrigating Wound Retractor Device AGENCY: Food and Drug Administration, HHS. E:\FR\FM\02JAR1.SGM 02JAR1

Agencies

[Federal Register Volume 83, Number 1 (Tuesday, January 2, 2018)]
[Rules and Regulations]
[Pages 20-22]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-28262]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 864

[Docket No. FDA-2017-N-6780]


Medical Devices; Hematology and Pathology Devices; Classification 
of the Whole Slide Imaging System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

SUMMARY: The Food and Drug Administration (FDA or we) is classifying 
the whole slide imaging system into class II (special controls). The 
special controls that apply to the device type are identified in this 
order and will be part of the codified language for the whole slide 
imaging system's classification. We are taking this action because we 
have determined that classifying the device into class II (special 
controls) will provide a reasonable assurance of safety and 
effectiveness of the device. We believe this action will also enhance 
patients' access to beneficial innovative devices, in part by reducing 
regulatory burdens.

[[Page 21]]


DATES: This order is effective January 2, 2018. The classification was 
applicable on April 12, 2017.

FOR FURTHER INFORMATION CONTACT: Steven Tjoe, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4550, Silver Spring, MD 20993-0002, 301-796-5866, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the whole slide imaging system as 
class II (special controls), which we have determined will provide a 
reasonable assurance of safety and effectiveness. In addition, we 
believe this action will enhance patients' access to beneficial 
innovation, in part by reducing regulatory burdens by placing the 
device into a lower device class than the automatic class III 
assignment.
    The automatic assignment of class III occurs by operation of law 
and without any action by FDA, regardless of the level of risk posed by 
the new device. Any device that was not in commercial distribution 
before May 28, 1976, is automatically classified as, and remains 
within, class III and requires premarket approval unless and until FDA 
takes an action to classify or reclassify the device (see 21 U.S.C. 
360c(f)(1)). We refer to these devices as ``postamendments devices'' 
because they were not in commercial distribution prior to the date of 
enactment of the Medical Device Amendments of 1976, which amended the 
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to 
classify or reclassify a device into class I or II. We may issue an 
order finding a new device to be substantially equivalent under section 
513(i) of the FD&C Act (see 21 U.S.C. 360c(i)) to a predicate device 
that does not require premarket approval. We determine whether a new 
device is substantially equivalent to a predicate by means of the 
procedures for premarket notification under section 510(k) of the FD&C 
Act (21 U.S.C. 360(k) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification, 
a common name for the process authorized under section 513(f)(2) of the 
FD&C Act. Section 207 of the Food and Drug Administration Modernization 
Act of 1997 established the first procedure for De Novo classification 
(Pub. L. 105-115). Section 607 of the Food and Drug Administration 
Safety and Innovation Act modified the De Novo application process by 
adding a second procedure (Pub. L. 112-144). A device sponsor may 
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device 
that has not previously been classified. After receiving an order from 
FDA classifying the device into class III under section 513(f)(1) of 
the FD&C Act, the person then requests a classification under section 
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k) 
and then a request for classification, if the person determines that 
there is no legally marketed device upon which to base a determination 
of substantial equivalence, that person requests a classification under 
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required 
to classify the device by written order within 120 days. The 
classification will be according to the criteria under section 
513(a)(1) of the FD&C Act. Although the device was automatically placed 
within class III, the De Novo classification is considered to be the 
initial classification of the device.
    We believe this De Novo classification will enhance patients' 
access to beneficial innovation, in part by reducing regulatory 
burdens. When FDA classifies a device into class I or II via the De 
Novo process, the device can serve as a predicate for future devices of 
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a 
result, other device sponsors do not have to submit a De Novo request 
or premarket approval application in order to market a substantially 
equivalent device (see 21 U.S.C. 360c(i), defining ``substantial 
equivalence''). Instead, sponsors can use the less-burdensome 510(k) 
process, when necessary, to market their device.

II. De Novo Classification

    On December 1, 2016, Philips Medical Systems Nederland B.V. 
submitted a request for De Novo classification of the Philips 
IntelliSite Pathology Solution (PIPS). FDA reviewed the request in 
order to classify the device under the criteria for classification set 
forth in section 513(a)(1) of the FD&C Act. We classify devices into 
class II if general controls by themselves are insufficient to provide 
reasonable assurance of safety and effectiveness, but there is 
sufficient information to establish special controls that, in 
combination with the general controls, provide reasonable assurance of 
the safety and effectiveness of the device for its intended use (see 21 
U.S.C. 360c(a)(1)(B)). After review of the information submitted in the 
request, we determined that the device can be classified into class II 
with the establishment of special controls. FDA has determined that 
these special controls, in addition to the general controls, will 
provide reasonable assurance of the safety and effectiveness of the 
device.
    Therefore, on April 12, 2017, FDA issued an order to the requester 
classifying the device into class II. FDA is codifying the 
classification of the device by adding 21 CFR 864.3700. We have named 
the generic type of device the whole slide imaging system, and it is 
identified as an automated digital slide creation, viewing, and 
management system intended as an aid to the pathologist to review and 
interpret digital images of surgical pathology slides. The system 
generates digital images that would otherwise be appropriate for manual 
visualization by conventional light microscopy.
    FDA has identified the following risks to health associated 
specifically with this type of device and the measures required to 
mitigate these risks in table 1.

    Table 1--Whole Slide Imaging System Risks and Mitigation Measures
------------------------------------------------------------------------
                                            Mitigation measures/21 CFR
            Identified risk                          Section
------------------------------------------------------------------------
Inaccurate or missing results leading    General controls;
 to, for example, incorrect diagnosis.   Special control (1) (21 CFR
                                          864.3700(b)(1)); and,
                                         Special control (2) (21 CFR
                                          864.3700(b)(2)).
Delayed results........................  General controls;
                                         Special control (1) (21 CFR
                                          864.3700(b)(1)); and,
                                         Special control (2) (21 CFR
                                          864.3700(b)(2)).
------------------------------------------------------------------------


[[Page 22]]

    FDA has determined that special controls, in combination with the 
general controls, address these risks to health and provide reasonable 
assurance of safety and effectiveness. For a device to fall within this 
classification, and thus avoid automatic classification in class III, 
it would have to comply with the special controls named in this final 
order. The necessary special controls appear in the regulation codified 
by this order. This device is subject to premarket notification 
requirements under section 510(k) of the FD&C Act.

III. Analysis of Environmental Impact

    The Agency has 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.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to 
previously approved collections of information found in other FDA 
regulations. These collections of information 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 collections of information in 
the guidance document ``De Novo Classification Process (Evaluation of 
Automatic Class III Designation)'' have been approved under OMB control 
number 0910-0844; the collections of information in 21 CFR part 814, 
subparts A through E, regarding premarket approval, have been approved 
under OMB control number 0910-0231; the collections of information in 
part 21 CFR 807, subpart E, regarding premarket notification 
submissions, have been approved under OMB control number 0910-0120; and 
the collections of information in 21 CFR parts 801 and 809, regarding 
labeling, have been approved under OMB control number 0910-0485.

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 is revised to read as follows:

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


0
2. Add Sec.  864.3700 to subpart D to read as follows:


Sec.  864.3700  Whole slide imaging system.

    (a) Identification. The whole slide imaging system is an automated 
digital slide creation, viewing, and management system intended as an 
aid to the pathologist to review and interpret digital images of 
surgical pathology slides. The system generates digital images that 
would otherwise be appropriate for manual visualization by conventional 
light microscopy.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Premarket notification submissions must include the following 
information:
    (i) The indications for use must specify the tissue specimen that 
is intended to be used with the whole slide imaging system and the 
components of the system.
    (ii) A detailed description of the device and bench testing results 
at the component level, including for the following, as appropriate:
    (A) Slide feeder;
    (B) Light source;
    (C) Imaging optics;
    (D) Mechanical scanner movement;
    (E) Digital imaging sensor;
    (F) Image processing software;
    (G) Image composition techniques;
    (H) Image file formats;
    (I) Image review manipulation software;
    (J) Computer environment; and
    (K) Display system.
    (iii) Detailed bench testing and results at the system level, 
including for the following, as appropriate:
    (A) Color reproducibility;
    (B) Spatial resolution;
    (C) Focusing test;
    (D) Whole slide tissue coverage;
    (E) Stitching error; and
    (F) Turnaround time.
    (iv) Detailed information demonstrating the performance 
characteristics of the device, including, as appropriate:
    (A) Precision to evaluate intra-system and inter-system precision 
using a comprehensive set of clinical specimens with defined, 
clinically relevant histologic features from various organ systems and 
diseases. Multiple whole slide imaging systems, multiple sites, and 
multiple readers must be included.
    (B) Reproducibility data to evaluate inter-site variability using a 
comprehensive set of clinical specimens with defined, clinically 
relevant histologic features from various organ systems and diseases. 
Multiple whole slide imaging systems, multiple sites, and multiple 
readers must be included.
    (C) Data from a clinical study to demonstrate that viewing, 
reviewing, and diagnosing digital images of surgical pathology slides 
prepared from tissue slides using the whole slide imaging system is 
non-inferior to using an optical microscope. The study should evaluate 
the difference in major discordance rates between manual digital (MD) 
and manual optical (MO) modalities when compared to the reference 
(e.g., main sign-out diagnosis).
    (D) A detailed human factor engineering process must be used to 
evaluate the whole slide imaging system user interface(s).
    (2) Labeling compliant with 21 CFR 809.10(b) must include the 
following:
    (i) The intended use statement must include the information 
described in paragraph (b)(1)(i) of this section, as applicable, and a 
statement that reads, ``It is the responsibility of a qualified 
pathologist to employ appropriate procedures and safeguards to assure 
the validity of the interpretation of images obtained using this 
device.''
    (ii) A description of the technical studies and the summary of 
results, including those that relate to paragraphs (b)(1)(ii) and (iii) 
of this section, as appropriate.
    (iii) A description of the performance studies and the summary of 
results, including those that relate to paragraph (b)(1)(iv) of this 
section, as appropriate.
    (iv) A limiting statement that specifies that pathologists should 
exercise professional judgment in each clinical situation and examine 
the glass slides by conventional microscopy if there is doubt about the 
ability to accurately render an interpretation using this device alone.

    Dated: December 26, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-28262 Filed 12-29-17; 8:45 am]
 BILLING CODE 4164-01-P


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