82 FR 51567 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Autosomal Recessive Carrier Screening Gene Mutation Detection System
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 214 (November 7, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 214 (November 7, 2017)
| Page Range | 51567-51570 | |
| FR Document | 2017-24162 |
[Federal Register Volume 82, Number 214 (Tuesday, November 7, 2017)] [Rules and Regulations] [Pages 51567-51570] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-24162] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2015-N-3455] Medical Devices; Exemption From Premarket Notification; Class II Devices; Autosomal Recessive Carrier Screening Gene Mutation Detection System AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is publishing an order to exempt autosomal recessive carrier screening gene mutation detection systems from the premarket notification requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in effect for autosomal recessive carrier screening gene mutation detection systems. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. FDA is also amending the codified language for the autosomal recessive carrier screening gene mutation detection system devices classification regulation to reflect this final determination. DATES: This order is effective November 7, 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. SUPPLEMENTARY INFORMATION: I. Statutory Background Section 510(k) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360(k)) and the implementing regulations, 21 CFR part 807 subpart E, require persons who intend to market a device to submit and obtain FDA clearance of a premarket notification (510(k)) containing information that allows FDA to determine whether the new device is ``substantially equivalent'' within the meaning of section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a legally marketed device that does not require premarket approval. On December 13, 2016, the 21st Century Cures Act (Pub. L. 114-255) (Cures Act) was signed into law. Section 3054 of the Cures Act amended section 510(m) of the FD&C Act. As amended, section 510(m)(2) provides that, 1 calendar day after the date of publication of the final list under paragraph (1)(B), FDA may exempt a class II device from the requirement to submit a report under section 510(k) of the FD&C Act, upon its own initiative or a petition of an interested person, if FDA determines that a 510(k) is not necessary to provide reasonable assurance of the safety and effectiveness of the device. This section requires FDA to publish in the Federal Register a notice of intent to exempt a device, or of the petition, and to provide a 60-calendar-day comment period. Within 120 days of publication of such notice, FDA must publish an order in the Federal Register that sets forth its final determination regarding the exemption of the device that was the subject of the notice. If FDA fails to respond to a petition under this section within 180 days of receiving it, the petition shall be deemed granted. II. Criteria for Exemption There are a number of factors FDA may consider to determine whether a 510(k) is necessary to provide reasonable assurance of the safety and effectiveness of a class II device. These factors are discussed in the January 21, 1998, Federal Register notice (63 FR 3142) and subsequently in the guidance the Agency issued on February 19, 1998, entitled ``Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff'' (referred to herein as the Class II 510(k) Exemption Guidance) (Ref. 1). III. Device Description On February 19, 2015, FDA completed its review of a De Novo request for classification of the 23andMe [[Page 51568]] Personal Genome Service (PGS) Carrier Screening Test for Bloom syndrome. FDA classified the 23andMe PGS Carrier Screening Test for Bloom syndrome, and substantially equivalent devices of this generic type, into class II (special controls) under the generic name ``Autosomal recessive carrier screening gene mutation detection system.'' This type of device is a qualitative in vitro molecular diagnostic system used for genotyping of clinically relevant variants in genomic DNA isolated from human specimens intended for prescription use or over-the-counter (OTC) use. The device is intended for autosomal recessive disease carrier screening in adults of reproductive age. The device is not intended for copy number variation, cytogenetic, or biochemical testing. FDA believes that 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 determining substantial equivalence for future devices within that type (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 a 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. In the Federal Register of October 27, 2015 (80 FR 65774), FDA published a notice (``October 2015 notice'') announcing its intent to exempt autosomal recessive carrier screening gene mutation detection system devices from premarket notification requirements, subject to certain limitations, and provided opportunity for interested persons to submit comments by November 27, 2015. After reviewing comments received (summarized in section IV), FDA is now providing its final determination for autosomal recessive carrier screening gene mutation detection system devices by exempting this type of device from premarket notification requirements, subject to certain limitations as identified in this notice. FDA is also amending the codified language for the autosomal recessive carrier screening gene mutation detection system devices classification regulation to reflect this final determination. Persons with pending 510(k) submissions for devices that are now exempt from premarket notification, subject to the limitations, should withdraw their submissions. IV. Comments on the Proposed Exemption and FDA Response In response to the October 2015 notice announcing FDA's intent to exempt autosomal recessive carrier screening gene mutation detection system devices from premarket notification requirements, FDA received submissions from three commenters--a device industry manufacturer, a professional organization, and a health care organization--supporting an exemption from premarket notification for this type of device. To make it easier to identify comments and our responses, the word ``Comment'' and a comment number appear in parentheses before each comment's description, and the word ``Response'' in parentheses precedes each response. Similar comments are grouped together under the same number. Specific issues raised by the comments and the Agency's responses follow. (Comment 1) Two commenters requested that FDA clarify that the list of autosomal recessive carrier diseases included in the October 2015 notice is not exhaustive or expand the list of diseases and conditions covered by the exemption to include all diseases and conditions described in the scientific literature as inherited in an autosomal recessive manner. One commenter further requested that FDA clarify that the determination of the applicability of Sec. 866.5940 (21 CFR 866.5940) should be based upon scientific and clinical literature as to the autosomal recessive nature of the disease or condition. (Response) The diseases and conditions listed in table 1 of the October 2015 notice were based upon a limited review of the scientific and clinical literature at that time. After consideration of the public comments, FDA agrees that the autosomal recessive diseases and conditions listed in that table should be treated as illustrative, and not an exhaustive list. Based on FDA's review of current scientific and clinical literature, FDA would not consider screening for autosomal recessive carrier status by detection of clinically relevant gene mutations associated with a large variety of diseases and conditions, in addition to those listed in table 1 of the October 2015 notice, to constitute a different intended use from that of a legally marketed device in the generic type under Sec. 866.5940 for purposes of Sec. 866.9 (21 CFR 866.9). Because FDA agrees that the list of diseases and conditions provided in the October 2015 notice is not comprehensive, and that applicability of Sec. 866.5940 should be based upon scientific and clinical literature as to the autosomal recessive nature of a particular disease or condition, we are not providing a revised list in this final order. (Comment 2) One commenter requested clarification that Sec. 866.5940 applies to OTC carrier detection devices for the determination of carrier status by detection of clinically relevant gene mutations associated with cystic fibrosis. (Response) In the October 2015 notice, FDA stated ``[a] gene mutation detection system indicated for the determination of carrier status by detection of clinically relevant gene mutations associated with Cystic Fibrosis is not 510(k)-exempt since it is a class II device subject to premarket notification and special controls under 21 CFR 866.5900--Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection system.'' Similarly, in the final order announcing the classification of an autosomal recessive carrier screening gene mutation detection system into class II (80 FR 65626, October 27, 2015), FDA stated ``A gene mutation detection system indicated for the determination of carrier status by detection of clinically relevant gene mutations associated with cystic fibrosis is separately classified under 21 CFR 866.5900--Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection system (class II, special controls), and is thus not included in the de novo classification.'' However, after considering the comments regarding this exemption action, and after reviewing the devices that are classified as CTFR gene mutation detection systems under Sec. 866.5900 (21 CFR 866.5900), FDA is now clarifying that an OTC gene mutation detection system indicated for the determination of autosomal recessive carrier status by detection of clinically relevant gene mutations associated with cystic fibrosis (``OTC Cystic Fibrosis carrier screening test'') is included within the scope of the classification regulation for an autosomal recessive carrier screening gene mutation detection system (Sec. 866.5940) and this exemption action. At the time FDA classified a CFTR gene mutation detection system under Sec. 866.5900, we were not aware of any OTC Cystic Fibrosis carrier screening tests, and it was not our intent at the time to classify this test for OTC use. We also note that, to date, the only Cystic Fibrosis carrier screening tests that have been cleared by FDA under Sec. 866.5900 are for prescription use only. Finally, [[Page 51569]] FDA does not believe that the special controls under Sec. 866.5900(b) would reasonably assure the safety and effectiveness of OTC Cystic Fibrosis carrier screening tests, as such special controls were developed to be applicable to prescription use only tests. For example, when classifying a CFTR gene mutation detection system into class II, FDA determined that the special controls under Sec. 866.5900(b), in conjunction with general controls, provided a reasonable assurance of the safety and effectiveness of the device. One risk to health that FDA identified was that ``errors in interpretation of results may lead to improper clinical recommendations and medical patient management.'' The special controls concerning generation of test results, interpretation of test results, and precautions for interpretation of the test results were developed only for prescription use only tests with health care providers in mind (see Section 6--Device Description; Test Results/ Reporting, Section 10--Labeling; Interpretation of Results, and Section 10--Labeling; Precautions for interpretations of the ``Class II Special Controls Guidance Document: CFTR Gene Mutation Detection Systems'' (October 26, 2005) (Ref. 2). Therefore, FDA is clarifying that with regard to gene mutation detection systems indicated for the determination of carrier status by detection of clinically relevant gene mutations associated with cystic fibrosis, the classification regulation Sec. 866.5900 is only applicable to prescription use only tests. FDA is further clarifying that we would not consider a gene mutation detection system indicated for use as an OTC device for the determination of carrier status by detection of clinically relevant gene mutations associated with cystic fibrosis to constitute a different intended use from that of a legally marketed device in the generic type Sec. 866.5940 for purposes of Sec. 866.9(a). As such, OTC Cystic Fibrosis carrier screening tests are within the scope of the classification regulation for an autosomal recessive carrier screening gene mutation detection system (Sec. 866.5940) and are included within the scope of this action. (Comment 3) One commenter requested that the exemption be expanded to include carrier screening for X-linked conditions. The commenter further requested that the exemption be expanded to allow for the reporting of diagnostic results. (Response) The October 2015 notice and this final order concern the exemption from premarket notification of autosomal recessive carrier screening gene mutation detection systems in the generic type Sec. 866.5940. Devices within the scope of the Sec. 866.5940 regulation for autosomal recessive carrier screening gene mutation detection systems are intended for autosomal recessive carrier screening in adults of reproductive age. The requested indications for carrier screening for X-linked conditions and for reporting of diagnostic results are outside the scope of the Sec. 866.5940 regulation. As this final order concerns only exemption of devices within the Sec. 866.5940 regulation, the request to expand the exemption to include carrier screening for X-linked conditions or for the reporting of diagnostic results is outside the scope of this action. (Comment 4) The three commenters were generally supportive of the regulation and special controls established for the device type, including for the special controls that relate to genetic counseling (e.g., Sec. 866.5940(b)(1) and (b)(4)(iii)(A)). Two commenters requested FDA provide additional recommendations that relate to the special control requirements related to genetic counseling. (Response) FDA appreciates the comments supporting the regulation and special controls established for the device type. FDA believes that the class II special controls established for the device type, along with the applicable general controls, provides reasonable assurance of the safety and effectiveness of the device type. FDA notes that while the comments received did not propose specific amendments to the special control requirements, such discussion is outside the scope of the October 2015 notice and this final order, which concerns the exemption from premarket notification of autosomal recessive carrier screening gene mutation detection systems in the generic type Sec. 866.5940. V. Exemption for Autosomal Recessive Carrier Screening Gene Mutation Detection System Devices FDA has assessed the need for 510(k) clearance for this type of device by considering the factors discussed in the January 21, 1998, Federal Register notice (63 FR 3142) and subsequently in the Class II 510(k) Exemption Guidance, as previously discussed in the October 2015 notice, and has determined they weigh in favor of 510(k) exemption, subject to certain limitations discussed later in this order. Therefore, for the reasons set forth in the Federal Register of October 27, 2015, and as informed by the comments received and FDA's understanding and experience with autosomal recessive carrier screening gene detection systems, FDA has determined that premarket notification is not necessary to assure the safety and effectiveness of autosomal recessive carrier screening gene detection systems, so long as the limitations on exemption described later in this document are not met. VI. Limitations on Exemption This exemption from 510(k) for an autosomal recessive carrier screening gene mutation detection system applies only to those devices that have existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type, or, in the case of in vitro diagnostic devices, for which a misdiagnosis, as a result of using the device, would not be associated with high morbidity or mortality. Therefore, a manufacturer of an autosomal recessive carrier screening gene mutation detection system would still be required to submit a premarket notification to FDA before introducing a device or delivering it for introduction into commercial distribution when the device meets any of the conditions described in Sec. 866.9, except Sec. 866.9(c)(2) to the extent it may include an autosomal recessive carrier screening gene mutation detection system, for the reasons explained in the October 2015 notice. Specifically, an autosomal recessive carrier screening gene mutation detection system is not exempt from the premarket notification requirement if such device: (1) Has an intended use that is different from the intended use of a legally marketed device in that generic type; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only; or (2) operates using a different fundamental scientific technology than that used by a legally marketed device in that generic type; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using a DNA probe or nucleic acid hybridization or amplification technology rather than culture or immunoassay technology; or (3) is an in vitro device that is intended: for use in the diagnosis, monitoring or screening of neoplastic diseases with the exception of immunohistochemical devices; for measuring an analyte which serves as a surrogate marker for screening, diagnosis, or monitoring of life threatening diseases, such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction, or to monitor therapy; for assessing the [[Page 51570]] risk of cardiovascular diseases; for use in diabetes management; for identifying or inferring the identity of a microorganism directly from clinical material; for detection of antibodies to microorganisms other than immunoglobulin G (IgG) and IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma; for noninvasive testing; or for near-patient testing (point of care). Exemption from the requirement of premarket notification does not exempt a device from other applicable regulatory controls under the FD&C Act, including the applicable general and special controls. Indeed, FDA's decision to grant 510(k) exemption for these devices is based, in part, on the special controls, in combination with general controls, providing sufficiently rigorous mitigations for the risks identified for this generic type. This exemption from 510(k), subject to the limitations described above, is immediately in effect for autosomal recessive carrier screening gene mutation detection systems. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with Federal regulation. Specifically, regulated industry will no longer have to invest time and resources in premarket notifications, including preparation of documents and data for submission to FDA, payment of user fees associated with 510(k) submissions, and responding to questions and requests for additional information from FDA during 510(k) review for devices in this exempted type. 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 notice refers to previously approved collections of information found in 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 21 CFR part 807, subpart, E have been approved under OMB control number 0910-0120 and the collections of information in 21 CFR parts 801 and 809 have been approved under OMB control number 0910-0485. IX. 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; they are also available electronically at https://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. FDA Guidance, ``Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff,'' February 19, 1998, available at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf. 2. FDA Guidance for Industry and FDA Staff ``Class II Special Controls Guidance Document: CFTR Gene Mutation Detection Systems,'' October 26, 2005, available at: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071104.pdf. List of Subjects in 21 CFR Part 866 Biologics, Laboratories, Medical devices. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 866 is amended as follows: PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES 0 1. The authority citation for part 866 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 0 2. In Sec. 866.5940, revise paragraph (b) introductory text to read as follows: Sec. 866.5940 Autosomal recessive carrier screening gene mutation detection system. * * * * * (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in Sec. 866.9, except Sec. 866.9(c)(2). Autosomal recessive carrier screening gene mutation detection system must comply with the following special controls: * * * * * Dated: November 1, 2017. Lauren Silvis, Chief of Staff. [FR Doc. 2017-24162 Filed 11-6-17; 8:45 am] BILLING CODE 4164-01-P
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range of age and educational levels and lead to prophylactic screening, SUPPLEMENTARY INFORMATION:
have no prior experience with the test confirmatory procedures, or treatments
I. Statutory Background
or its manufacturer. These factors shall that may incur morbidity or mortality to
be well defined in the inclusion and the patient; Section 510(k) of the Federal Food,
exclusion criteria. (iii) Assessing the presence of genetic Drug, and Cosmetic Act (the FD&C Act)
(ii) All sources of bias must be variants that impact the metabolism, (21 U.S.C. 360(k)) and the implementing
predefined and accounted for in the exposure, response, risk of adverse regulations, 21 CFR part 807 subpart E,
study results with regard to both events, dosing, or mechanisms of require persons who intend to market a
responders and non-responders. prescription or over-the-counter device to submit and obtain FDA
(iii) The testing must follow a format medications; or clearance of a premarket notification
where users have limited time to (iv) Assessing the presence of (510(k)) containing information that
complete the studies (such as an onsite deterministic autosomal dominant allows FDA to determine whether the
survey format and a one-time visit with variants. new device is ‘‘substantially equivalent’’
a cap on the maximum amount of time within the meaning of section 513(i) of
Dated: November 1, 2017.
that a participant has to complete the the FD&C Act (21 U.S.C. 360c(i)) to a
Lauren Silvis, legally marketed device that does not
tests).
(iv) Users must be randomly assigned Chief of Staff. require premarket approval.
to study arms. Test reports in the user [FR Doc. 2017–24159 Filed 11–6–17; 8:45 am] On December 13, 2016, the 21st
comprehension study given to users BILLING CODE 4164–01–P Century Cures Act (Pub. L. 114–255)
must define the target condition being (Cures Act) was signed into law. Section
tested and related symptoms, explain 3054 of the Cures Act amended section
the intended use and limitations of the DEPARTMENT OF HEALTH AND 510(m) of the FD&C Act. As amended,
test, explain the relevant ethnicities in HUMAN SERVICES section 510(m)(2) provides that, 1
regard to the variant tested, explain calendar day after the date of
genetic health risks and relevance to the Food and Drug Administration publication of the final list under
user’s ethnicity, and assess participants’ paragraph (1)(B), FDA may exempt a
ability to understand the following 21 CFR Part 866 class II device from the requirement to
comprehension concepts: The test’s [Docket No. FDA–2015–N–3455] submit a report under section 510(k) of
limitations, purpose, appropriate action, the FD&C Act, upon its own initiative or
test results, and other factors that may Medical Devices; Exemption From a petition of an interested person, if
have an impact on the test results. Premarket Notification; Class II FDA determines that a 510(k) is not
(v) Study participants must be Devices; Autosomal Recessive Carrier necessary to provide reasonable
untrained, be naı̈ve to the test subject of Screening Gene Mutation Detection assurance of the safety and effectiveness
the study, and be provided the labeling System of the device. This section requires FDA
prior to the start of the user AGENCY: Food and Drug Administration, to publish in the Federal Register a
comprehension study. HHS. notice of intent to exempt a device, or
(vi) The user comprehension study of the petition, and to provide a 60-
must meet the predefined primary ACTION: Final order. calendar-day comment period. Within
endpoint criteria, including a minimum SUMMARY: The Food and Drug 120 days of publication of such notice,
of a 90 percent or greater overall Administration (FDA or Agency) is FDA must publish an order in the
comprehension rate (i.e., selection of the publishing an order to exempt Federal Register that sets forth its final
correct answer) for each comprehension autosomal recessive carrier screening determination regarding the exemption
concept. Other acceptance criteria may gene mutation detection systems from of the device that was the subject of the
be acceptable depending on the concept the premarket notification requirements, notice. If FDA fails to respond to a
being tested. Meeting or exceeding this subject to certain limitations. This petition under this section within 180
overall comprehension rate exemption from 510(k), subject to days of receiving it, the petition shall be
demonstrates that the materials certain limitations, is immediately in deemed granted.
presented to the user are adequate for effect for autosomal recessive carrier
over-the-counter use. II. Criteria for Exemption
screening gene mutation detection
(vii) The analysis of the user There are a number of factors FDA
systems. This exemption will decrease
comprehension results must include may consider to determine whether a
regulatory burdens on the medical
results regarding reports that are 510(k) is necessary to provide
device industry and will eliminate
provided for each gene/variant/ethnicity reasonable assurance of the safety and
private costs and expenditures required
tested, statistical methods used to effectiveness of a class II device. These
to comply with certain Federal
analyze all data sets, and completion factors are discussed in the January 21,
regulations. FDA is also amending the
rate, non-responder rate, and reasons for 1998, Federal Register notice (63 FR
codified language for the autosomal
nonresponse/data exclusion. A 3142) and subsequently in the guidance
recessive carrier screening gene
summary table of comprehension rates the Agency issued on February 19, 1998,
mutation detection system devices
regarding comprehension concepts (e.g., entitled ‘‘Procedures for Class II Device
classification regulation to reflect this
purpose of test, test results, test Exemptions from Premarket
final determination.
limitations, ethnicity relevance for the Notification, Guidance for Industry and
DATES: This order is effective November CDRH Staff’’ (referred to herein as the
test results, etc.) for each study report
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must be included. 7, 2017. Class II 510(k) Exemption Guidance)
(4) The intended use of the device FOR FURTHER INFORMATION CONTACT: (Ref. 1).
must not include the following Steven Tjoe, Center for Devices and
Radiological Health, Food and Drug III. Device Description
indications for use:
(i) Prenatal testing; Administration, 10903 New Hampshire On February 19, 2015, FDA
(ii) Determining predisposition for Ave., Bldg. 66, Rm. 4550, Silver Spring, completed its review of a De Novo
cancer where the result of the test may MD 20993–0002, 301–796–5866. request for classification of the 23andMe
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Personal Genome Service (PGS) Carrier IV. Comments on the Proposed based upon scientific and clinical
Screening Test for Bloom syndrome. Exemption and FDA Response literature as to the autosomal recessive
FDA classified the 23andMe PGS Carrier In response to the October 2015 notice nature of a particular disease or
Screening Test for Bloom syndrome, announcing FDA’s intent to exempt condition, we are not providing a
and substantially equivalent devices of autosomal recessive carrier screening revised list in this final order.
this generic type, into class II (special (Comment 2) One commenter
gene mutation detection system devices
controls) under the generic name requested clarification that § 866.5940
from premarket notification
‘‘Autosomal recessive carrier screening applies to OTC carrier detection devices
requirements, FDA received
gene mutation detection system.’’ This for the determination of carrier status by
submissions from three commenters—a
type of device is a qualitative in vitro detection of clinically relevant gene
device industry manufacturer, a
molecular diagnostic system used for mutations associated with cystic
professional organization, and a health
genotyping of clinically relevant fibrosis.
care organization—supporting an (Response) In the October 2015
variants in genomic DNA isolated from exemption from premarket notification
human specimens intended for notice, FDA stated ‘‘[a] gene mutation
for this type of device. detection system indicated for the
prescription use or over-the-counter To make it easier to identify
(OTC) use. The device is intended for determination of carrier status by
comments and our responses, the word detection of clinically relevant gene
autosomal recessive disease carrier ‘‘Comment’’ and a comment number
screening in adults of reproductive age. mutations associated with Cystic
appear in parentheses before each Fibrosis is not 510(k)-exempt since it is
The device is not intended for copy comment’s description, and the word
number variation, cytogenetic, or a class II device subject to premarket
‘‘Response’’ in parentheses precedes notification and special controls under
biochemical testing. each response. Similar comments are 21 CFR 866.5900—Cystic fibrosis
FDA believes that De Novo grouped together under the same transmembrane conductance regulator
classification will enhance patients’ number. Specific issues raised by the (CFTR) gene mutation detection
access to beneficial innovation, in part comments and the Agency’s responses system.’’ Similarly, in the final order
by reducing regulatory burdens. When follow. announcing the classification of an
FDA classifies a device into class I or II (Comment 1) Two commenters autosomal recessive carrier screening
via the De Novo process, the device can requested that FDA clarify that the list gene mutation detection system into
serve as a predicate for determining of autosomal recessive carrier diseases class II (80 FR 65626, October 27, 2015),
substantial equivalence for future included in the October 2015 notice is FDA stated ‘‘A gene mutation detection
devices within that type (see 21 U.S.C. not exhaustive or expand the list of system indicated for the determination
360c(f)(2)(B)(i)). As a result, other diseases and conditions covered by the of carrier status by detection of
device sponsors do not have to submit exemption to include all diseases and clinically relevant gene mutations
a De Novo request or a premarket conditions described in the scientific associated with cystic fibrosis is
approval application in order to market literature as inherited in an autosomal separately classified under 21 CFR
a substantially equivalent device (see 21 recessive manner. One commenter 866.5900—Cystic fibrosis
U.S.C. 360c(i), defining ‘‘substantial further requested that FDA clarify that transmembrane conductance regulator
equivalence’’). Instead, sponsors can use the determination of the applicability of (CFTR) gene mutation detection system
the less-burdensome 510(k) process, § 866.5940 (21 CFR 866.5940) should be (class II, special controls), and is thus
when necessary, to market their device. based upon scientific and clinical not included in the de novo
In the Federal Register of October 27, literature as to the autosomal recessive classification.’’
2015 (80 FR 65774), FDA published a nature of the disease or condition. However, after considering the
notice (‘‘October 2015 notice’’) (Response) The diseases and comments regarding this exemption
announcing its intent to exempt conditions listed in table 1 of the action, and after reviewing the devices
autosomal recessive carrier screening October 2015 notice were based upon a that are classified as CTFR gene
gene mutation detection system devices limited review of the scientific and mutation detection systems under
from premarket notification clinical literature at that time. After § 866.5900 (21 CFR 866.5900), FDA is
requirements, subject to certain consideration of the public comments, now clarifying that an OTC gene
limitations, and provided opportunity FDA agrees that the autosomal recessive mutation detection system indicated for
for interested persons to submit diseases and conditions listed in that the determination of autosomal
comments by November 27, 2015. After table should be treated as illustrative, recessive carrier status by detection of
reviewing comments received and not an exhaustive list. Based on clinically relevant gene mutations
(summarized in section IV), FDA is now FDA’s review of current scientific and associated with cystic fibrosis (‘‘OTC
providing its final determination for clinical literature, FDA would not Cystic Fibrosis carrier screening test’’) is
autosomal recessive carrier screening consider screening for autosomal included within the scope of the
gene mutation detection system devices recessive carrier status by detection of classification regulation for an
by exempting this type of device from clinically relevant gene mutations autosomal recessive carrier screening
premarket notification requirements, associated with a large variety of gene mutation detection system
subject to certain limitations as diseases and conditions, in addition to (§ 866.5940) and this exemption action.
identified in this notice. FDA is also those listed in table 1 of the October At the time FDA classified a CFTR
amending the codified language for the 2015 notice, to constitute a different gene mutation detection system under
autosomal recessive carrier screening intended use from that of a legally § 866.5900, we were not aware of any
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gene mutation detection system devices marketed device in the generic type OTC Cystic Fibrosis carrier screening
classification regulation to reflect this under § 866.5940 for purposes of § 866.9 tests, and it was not our intent at the
final determination. Persons with (21 CFR 866.9). Because FDA agrees that time to classify this test for OTC use. We
pending 510(k) submissions for devices the list of diseases and conditions also note that, to date, the only Cystic
that are now exempt from premarket provided in the October 2015 notice is Fibrosis carrier screening tests that have
notification, subject to the limitations, not comprehensive, and that been cleared by FDA under § 866.5900
should withdraw their submissions. applicability of § 866.5940 should be are for prescription use only. Finally,
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![51570 Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Rules and Regulations
risk of cardiovascular diseases; for use 809 have been approved under OMB Dated: November 1, 2017.
in diabetes management; for identifying control number 0910–0485. Lauren Silvis,
or inferring the identity of a Chief of Staff.
microorganism directly from clinical IX. References
[FR Doc. 2017–24162 Filed 11–6–17; 8:45 am]
material; for detection of antibodies to The following references are on BILLING CODE 4164–01–P
microorganisms other than display in the Dockets Management
immunoglobulin G (IgG) and IgG assays Staff (see ADDRESSES) and are available
when the results are not qualitative, or for viewing by interested persons
are used to determine immunity, or the DEPARTMENT OF COMMERCE
between 9 a.m. and 4 p.m., Monday
assay is intended for use in matrices United States Patent and Trademark
through Friday; they are also available
other than serum or plasma; for Office
electronically at https://
noninvasive testing; or for near-patient
testing (point of care). www.regulations.gov. FDA has verified
the Web site addresses, as of the date 37 CFR Part 42
Exemption from the requirement of
premarket notification does not exempt this document publishes in the Federal [Docket No. PTO–P–2016–0029]
a device from other applicable Register, but Web sites are subject to
regulatory controls under the FD&C Act, change over time. RIN 0651–AD10
including the applicable general and 1. FDA Guidance, ‘‘Procedures for Class II Rule on Attorney-Client Privilege for
special controls. Indeed, FDA’s decision Device Exemptions from Premarket Trials Before the Patent Trial and
to grant 510(k) exemption for these Notification, Guidance for Industry and Appeal Board
devices is based, in part, on the special CDRH Staff,’’ February 19, 1998,
controls, in combination with general available at https://www.fda.gov/ AGENCY: Patent Trial and Appeal Board,
controls, providing sufficiently rigorous downloads/MedicalDevices/ United States Patent and Trademark
mitigations for the risks identified for DeviceRegulationandGuidance/ Office, U.S. Department of Commerce.
this generic type. GuidanceDocuments/UCM080199.pdf. ACTION: Final rule.
This exemption from 510(k), subject 2. FDA Guidance for Industry and FDA Staff
to the limitations described above, is ‘‘Class II Special Controls Guidance SUMMARY: This final rule on attorney-
immediately in effect for autosomal Document: CFTR Gene Mutation client privilege amends the existing
recessive carrier screening gene Detection Systems,’’ October 26, 2005, rules relating to the United States Patent
mutation detection systems. This available at: https://www.fda.gov/ and Trademark Office (Office or
exemption will decrease regulatory downloads/MedicalDevices/ USPTO) trial practice for inter partes
burdens on the medical device industry DeviceRegulationandGuidance/ review, post-grant review, the
and will eliminate private costs and GuidanceDocuments/ucm071104.pdf. transitional program for covered
expenditures required to comply with business method patents, and derivation
Federal regulation. Specifically, List of Subjects in 21 CFR Part 866
proceedings that implemented
regulated industry will no longer have Biologics, Laboratories, Medical provisions of the Leahy-Smith America
to invest time and resources in devices. Invents Act (‘‘AIA’’) providing for trials
premarket notifications, including before the Office.
preparation of documents and data for Therefore, under the Federal Food, DATES: This rule is effective on
submission to FDA, payment of user Drug, and Cosmetic Act and under December 7, 2017.
fees associated with 510(k) submissions, authority delegated to the Commissioner
FOR FURTHER INFORMATION CONTACT:
and responding to questions and of Food and Drugs, 21 CFR part 866 is
amended as follows: Edward Elliott, Attorney Advisor, by
requests for additional information from
telephone at (571) 272–7024 or by email
FDA during 510(k) review for devices in
PART 866—IMMUNOLOGY AND at edward.elliott@uspto.gov.
this exempted type.
MICROBIOLOGY DEVICES SUPPLEMENTARY INFORMATION:
VII. Analysis of Environmental Impact Executive Summary: Purpose: This
We have determined under 21 CFR ■ 1. The authority citation for part 866 final rule clarifies situations where
25.34(b) that this action is of a type that continues to read as follows: privilege is recognized for
does not individually or cumulatively communications between clients and
Authority: 21 U.S.C. 351, 360, 360c, 360e, their domestic or foreign patent
have a significant effect on the human
360j, 360l, 371. attorneys and patent agents.
environment. Therefore, neither an
environmental assessment nor an ■ 2. In § 866.5940, revise paragraph (b) Background
environmental impact statement is introductory text to read as follows:
required. In February 2015, the USPTO held a
§ 866.5940 Autosomal recessive carrier roundtable and solicited comments on
VIII. Paperwork Reduction Act of 1995 screening gene mutation detection system. attorney-client privilege issues. See
This notice refers to previously * * * * * Notice of Roundtable and Request for
approved collections of information Comments on Domestic and
found in FDA regulations. These (b) Classification. Class II (special International Issues Related to
collections of information are subject to controls). The device is exempt from the Privileged Communications Between
review by the Office of Management and premarket notification procedures in Patent Practitioners and Their Clients,
subpart E of part 807 of this chapter
nshattuck on DSK9F9SC42PROD with RULES
Budget (OMB) under the Paperwork 80 FR 3953 (Jan. 26, 2015). As part of
Reduction Act of 1995 (44 U.S.C. 3501– subject to the limitations in § 866.9, that process, the USPTO requested
3520). The collections of information in except § 866.9(c)(2). Autosomal comments on whether communications
21 CFR part 807, subpart, E have been recessive carrier screening gene between patent applicants or owners
approved under OMB control number mutation detection system must comply with their U.S. patent agents or foreign
0910–0120 and the collections of with the following special controls: patent practitioners should be
information in 21 CFR parts 801 and * * * * * recognized as privileged to the same
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Document Created: 2018-10-25 10:25:49
Document Modified: 2018-10-25 10:25:49
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final order. | |
| Dates | This order is effective November 7, 2017. | |
| 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. | |
| FR Citation | 82 FR 51567 | |
| CFR Associated | Biologics; Laboratories and Medical Devices |
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