81 FR 68295 - Medical Devices; Exemption From Premarket Notification; Method, Metallic Reduction, Glucose (Urinary, Nonquantitative) Test System in a Reagent Tablet Format
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 192 (October 4, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 192 (October 4, 2016)
| Page Range | 68295-68297 | |
| FR Document | 2016-23901 |
[Federal Register Volume 81, Number 192 (Tuesday, October 4, 2016)] [Rules and Regulations] [Pages 68295-68297] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-23901] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 862 [Docket No. FDA-2016-P-0159] Medical Devices; Exemption From Premarket Notification; Method, Metallic Reduction, Glucose (Urinary, Nonquantitative) Test System in a Reagent Tablet Format AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is publishing an order denying a petition requesting exemption from the premarket notification requirements for method, metallic reduction, glucose (urinary, nonquantitative) devices that are in a reagent tablet format and are classified as class II devices as urinary glucose (nonquantitative) test system (hereinafter referred to as ''copper reduction tablet test''). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia. FDA is publishing this order in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA). DATES: This order is effective October 4, 2016. FOR FURTHER INFORMATION CONTACT: Sheila Connors, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4620, Silver Spring, MD 20993-0002, 301- 796-6181, [email protected]. SUPPLEMENTARY INFORMATION: I. Statutory Background Under section 513 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c), FDA must classify devices into one of three regulatory classes: Class I, class II, or class III. FDA classification of a device is determined by the amount of regulation necessary to provide a reasonable assurance of the safety and effectiveness of the device. Under the Medical Device Amendments of 1976 (1976 amendments) (Pub. L. 94-295), as amended by the Safe Medical Devices Act of 1990 (Pub. L. 101-629), devices are to be classified into class I (general controls) if there is information showing that the general controls of the FD&C Act are sufficient to assure safety and effectiveness; into class II (special controls) if general controls, by themselves, are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide such assurance; and into class III (premarket approval) if there is insufficient information to support classifying a device into class I or class II and the device is a life-sustaining or life-supporting device, or is for a use which is of substantial importance in preventing impairment of human health, or presents a potential unreasonable risk of illness or injury. Section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and the implementing regulations (21 CFR part 807) require persons who intend to market a device intended for human use to submit a premarket notification (510(k)) to FDA containing information that allows FDA to determine whether the device is ``substantially equivalent'' within the meaning of section 513(i) of the FD&C Act to a legally marketed device that does not require premarket approval. On November 21, 1997, the President signed into law FDAMA (Pub. L. 105-115). Section 206 of FDAMA, in part, added section 510(m) to the FD&C Act. Section 510(m)(1) of the FD&C Act requires FDA, within 60 days after enactment of FDAMA, to publish in the Federal Register a list of each type of class II device that does not require a report under section 510(k) of the FD&C Act to provide reasonable assurance of safety and effectiveness. Section 510(m) of the FD&C Act further provides that a 510(k) will no longer be required for these devices upon the date of publication of the list in the Federal Register. FDA published that list in the Federal Register of January 21, 1998 (63 FR 3142). Section 510(m)(2) of the FD&C Act provides that 1 day after the date of publication of the list under section 510(m)(1), FDA may exempt a class II device on its own initiative or upon 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. [[Page 68296]] 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 30- day comment period. Within 120 days of publication of this document, FDA must publish in the Federal Register 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. FDA classified the urinary glucose (nonquantitative) test system into class II effective July 30, 1987 (52 FR 16102 at 16122, May 1, 1987). The classification for urinary glucose (nonquantitative) test system is at Sec. 862.1340 (21 CFR 862.1340). The urinary glucose (nonquantitative) test system is identified as a device that is intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia. Devices under this classification regulation require premarket notification under section 510(k) of the FD&C Act. 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 guidance the Agency issued on February 19, 1998, entitled ``Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff'' (Ref. 1). Accordingly, FDA generally considers the following factors to determine whether premarket notification is necessary: (1) The device does not have a significant history of false or misleading claims or risks associated with inherent characteristics of the device; (2) characteristics of the device necessary for its safe and effective performance are well established; (3) changes in the device that could affect safety and effectiveness will either (a) be readily detectable by users by visual examination or other means such as routine testing, before causing harm, or (b) not materially increase the risk of injury, incorrect diagnosis, or ineffective treatment; and (4) any changes to the device would not be likely to result in a change in the device's classification. FDA may also consider that, even when exempting devices, these devices would still be subject to the limitations on exemptions. III. Petition On January 7, 2016, FDA received a petition requesting an exemption from premarket notification requirements for copper reduction tablet tests that are classified as class II devices under Sec. 862.1340, urinary glucose (nonquantitative) test system, from Evelyn Mirza, Biorex Labs, LLC. (See Docket No. FDA-2016-P-0159). On March 24, 2016 (81 FR 15728), FDA published a notice in the Federal Register announcing that this petition had been received and provided an opportunity for interested persons to submit comments on the petition by April 25, 2016, in accordance with section 510(m)(2) of the FD&C Act. FDA received no comments regarding this petition. FDA has completed review of the previously referenced petition and assessed the need for 510(k) clearance for copper reduction tablet test against the criteria laid out in section II. For the reasons described in section IV, FDA has determined that premarket notification is necessary to provide a reasonable assurance of the safety and effectiveness of the copper reduction tablet tests classified under Sec. 862.1340 and assigned the classification product code JIM. Accordingly, FDA responded to the petition by letter dated July 1, 2016, denying the petition within the 180-day timeframe under section 510(m)(2) of the FD&C Act. (See Docket No. FDA-2016-P-0159.) IV. Order After reviewing the petition, FDA has determined that the petition failed to provide information to demonstrate that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. Accordingly, FDA is denying the previously referenced petition for exemption from the premarket notification requirements. With regard to the first factor (section II, Criteria for Exemption), although there have been no medical device reports reported to the Agency in recent years, there have been numerous reports to the Agency \1\ and in medical literature of risks associated with the inherent characteristics of this device, including possible device- associated deaths, serious injuries, and malfunctions such as burns, explosions of the product bottle due to heat, and consumption of the device. For instance, there have been reports in the medical literature of patients consuming the tablets because of their similarity to pills, which has led to poisoning and one report of a death. Therefore, FDA does not agree with the petitioner that the use of the device is well established without any reports of patient or user injury, or that the device does not have a significant history of risks associated with inherent characteristics of the device. --------------------------------------------------------------------------- \1\ For more information, see Medical Device Reporting (MDR) database at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM. --------------------------------------------------------------------------- Additionally, failure to observe the reaction at all times after the tablet has been added to the sample is another risk associated with the inherent characteristics of the device. This can lead to a false- negative result and result in improper patient management, which can lead to serious injury or possibly death. The petition failed to demonstrate how the device's inherent risks can be mitigated or controlled without premarket notification to provide a reasonable assurance of the safety and effectiveness of the device. With regard to the second factor, the petition stated that a copper reduction tablet test can be used to evaluate pediatric patients for possible hereditary metabolic disorders through detection of reducing substances. For example, although all States require mandatory newborn screening for genetic metabolic defects, clinical laboratories may still use this device as a screening test on pediatric urine samples if there are any suspicions of metabolic disease prior to receiving newborn screening results or if the newborn screening results do not match the clinical state of the newborn. Although further diagnostic testing may be performed to confirm the result(s), physicians may immediately treat the newborn relying solely on the result of this test while awaiting the results for any followup diagnostic tests. False negative results also present a safety and effectiveness concern because followup diagnostic testing may not be performed, leading to the failure to start needed treatment for the newborn. The petition also stated that this device is used in the diagnosis, monitoring, and treatment of metabolic disorders such as diabetes mellitus. However, the petition failed to demonstrate that a premarket submission is not necessary to provide a reasonable assurance of the safety and effectiveness of the device for such uses, and FDA does not agree that the characteristics of the device necessary for its safe and effective use are well established. With regard to the third factor, FDA also does not agree that changes in the device that could affect safety and effectiveness will either be readily detectable or not materially increase [[Page 68297]] risks. For example, available quality control materials may contain glucose but do not contain other reducing sugars (e.g., galactose, lactose). Therefore, such materials might not readily detect an issue with the device's safety or effectiveness in detecting other reducing sugars, before causing harm. The petition provided insufficient information to support the position that changes in the device that could affect safety and effectiveness will either be readily detectable or not materially increase risks. Moreover, changes in the device that could affect safety and effectiveness might materially increase the risk of injury, incorrect diagnosis, or ineffective treatment given the device type's intended uses. The petition also did not provide information to the contrary. The petition did not provide any information regarding the fourth factor. In addition to these four factors, FDA considers the ``limitations on exemption.'' Manufacturers of any commercially distributed device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA prior to marketing the device when any of the limitations of exemption are exceeded. The general limitations of exemption from premarket notification contained in Sec. 862.9 (21 CFR 862.9) are broadly applicable to in vitro diagnostic (IVD) devices classified under part 862 (21 CFR part 862). Under Sec. 862.9, the exemption from the premarket notification requirements applies, in the case of IVD devices, only to those devices under part 862 for which misdiagnosis, as a result of using the device, would not be associated with high morbidity or mortality. FDA has previously assessed that this limitation is exceeded, and a premarket notification is necessary to provide a reasonable assurance of the safety and effectiveness of an IVD device, when such device is intended for use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism (Sec. 862.9(c)(2)) or intended for use in diabetes management (Sec. 862.9(c)(5)). The copper reduction tablet test described in the petition is intended for such uses and would likely exceed the limitations just described. Accordingly, for all of the foregoing reasons, the petition failed to demonstrate that a premarket submission is not necessary to provide a reasonable assurance of the safety and effectiveness of the device intended for such uses. Therefore, FDA is issuing this order denying the petition requesting exemption for a method, metallic reduction, glucose (urinary, nonquantitative) test system in a reagent tablet format that is intended to measure glucosuria (glucose in urine) from the premarket notification requirements. Manufacturers of this device type must continue to submit and receive FDA clearance of a 510(k) before marketing their device, as well as comply with all other applicable requirements under the FD&C Act. V. Reference The following reference is on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at http://www.regulations.gov. FDA has verified the Web site address, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. 1. ``Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff,'' February 1998, available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf. Dated: September 28, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-23901 Filed 10-3-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 192 / Tuesday, October 4, 2016 / Rules and Regulations 68295
exemption from the premarket February 1998, available at http:// class III. FDA classification of a device
notification requirements applies, in the www.fda.gov/downloads/ is determined by the amount of
case of IVD devices, only to those MedicalDevices/ regulation necessary to provide a
devices under part 862 for which DeviceRegulationandGuidance/ reasonable assurance of the safety and
GuidanceDocuments/UCM080199.pdf.
misdiagnosis, as a result of using the effectiveness of the device. Under the
device, would not be associated with Dated: September 28, 2016. Medical Device Amendments of 1976
high morbidity or mortality. FDA has Leslie Kux, (1976 amendments) (Pub. L. 94–295), as
previously assessed that this limitation Associate Commissioner for Policy. amended by the Safe Medical Devices
is exceeded, and a premarket [FR Doc. 2016–23899 Filed 10–3–16; 8:45 am] Act of 1990 (Pub. L. 101–629), devices
notification is necessary to provide a BILLING CODE 4164–01–P are to be classified into class I (general
reasonable assurance of the safety and controls) if there is information showing
effectiveness of an IVD device, when that the general controls of the FD&C
such device is intended for use in DEPARTMENT OF HEALTH AND Act are sufficient to assure safety and
screening or diagnosis of familial or HUMAN SERVICES effectiveness; into class II (special
acquired genetic disorders, including controls) if general controls, by
inborn errors of metabolism Food and Drug Administration themselves, are insufficient to provide
(§ 862.9(c)(2)) or intended for use in reasonable assurance of safety and
diabetes management (§ 862.9(c)(5)). 21 CFR Part 862 effectiveness, but there is sufficient
The petition argued that the copper information to establish special controls
[Docket No. FDA–2016–P–0159]
reduction tablet test is not intended for to provide such assurance; and into
use in screening or diagnosis of familial Medical Devices; Exemption From class III (premarket approval) if there is
and acquired genetic disorders, Premarket Notification; Method, insufficient information to support
including inborn errors of metabolism, Metallic Reduction, Glucose (Urinary, classifying a device into class I or class
or for use in diabetes management. Nonquantitative) Test System in a II and the device is a life-sustaining or
However, as explained previously, FDA Reagent Tablet Format life-supporting device, or is for a use
disagrees and believes that the copper which is of substantial importance in
reduction tablet test described in the AGENCY: Food and Drug Administration, preventing impairment of human
petition is intended for such uses and HHS. health, or presents a potential
would likely exceed the limitations ACTION: Final order. unreasonable risk of illness or injury.
previously mentioned. Section 510(k) of the FD&C Act (21
Accordingly, for all of the foregoing SUMMARY: The Food and Drug U.S.C. 360(k)) and the implementing
reasons, the petition failed to Administration (FDA) is publishing an regulations (21 CFR part 807) require
demonstrate that a premarket order denying a petition requesting persons who intend to market a device
submission is not necessary to provide exemption from the premarket intended for human use to submit a
a reasonable assurance of the safety and notification requirements for method, premarket notification (510(k)) to FDA
effectiveness of the device intended for metallic reduction, glucose (urinary, containing information that allows FDA
such uses. Therefore, FDA is issuing nonquantitative) devices that are in a to determine whether the device is
this order denying the petition reagent tablet format and are classified ‘‘substantially equivalent’’ within the
requesting exemption for a method, as class II devices as urinary glucose meaning of section 513(i) of the FD&C
metallic reduction, glucose (urinary, (nonquantitative) test system Act to a legally marketed device that
nonquantitative) test system in a reagent (hereinafter referred to as ’’copper does not require premarket approval.
tablet format that is intended to measure reduction tablet test’’). Urinary glucose On November 21, 1997, the President
glucosuria (glucose in urine) from the (nonquantitative) measurements are signed into law FDAMA (Pub. L. 105–
premarket notification requirements. used in the diagnosis and treatment of 115). Section 206 of FDAMA, in part,
Manufacturers of this device type must carbohydrate metabolism disorders added section 510(m) to the FD&C Act.
continue to submit and receive FDA including diabetes mellitus, Section 510(m)(1) of the FD&C Act
clearance of a 510(k) before marketing hypoglycemia, and hyperglycemia. FDA requires FDA, within 60 days after
their device, as well as comply with all is publishing this order in accordance enactment of FDAMA, to publish in the
other applicable requirements under the with procedures established by the Food Federal Register a list of each type of
FD&C Act. and Drug Administration Modernization class II device that does not require a
Act of 1997 (FDAMA). report under section 510(k) of the FD&C
V. Reference Act to provide reasonable assurance of
The following reference is on display DATES: This order is effective October 4,
safety and effectiveness. Section 510(m)
in the Division of Dockets Management 2016. of the FD&C Act further provides that a
(HFA–305), Food and Drug FOR FURTHER INFORMATION CONTACT: 510(k) will no longer be required for
Administration, 5630 Fishers Lane, Rm. Sheila Connors, Center for Devices and these devices upon the date of
1061, Rockville, MD 20852, and is Radiological Health (CDRH), Food and publication of the list in the Federal
available for viewing by interested Drug Administration, 10903 New Register. FDA published that list in the
persons between 9 a.m. and 4 p.m., Hampshire Ave., Bldg. 66, Rm. 4620, Federal Register of January 21, 1998 (63
Monday through Friday; it is also Silver Spring, MD 20993–0002, 301– FR 3142).
available electronically at http:// 796–6181, Sheila.Connors@fda.hhs.gov. Section 510(m)(2) of the FD&C Act
asabaliauskas on DSK3SPTVN1PROD with RULES
www.regulations.gov. FDA has verified SUPPLEMENTARY INFORMATION: provides that 1 day after the date of
the Web site address, as of the date this publication of the list under section
document publishes in the Federal I. Statutory Background 510(m)(1), FDA may exempt a class II
Register, but Web sites are subject to Under section 513 of the Federal device on its own initiative or upon
change over time. Food, Drug, and Cosmetic Act (the petition of an interested person, if FDA
1. ‘‘Procedures for Class II Device FD&C Act) (21 U.S.C. 360c), FDA must determines that a 510(k) is not necessary
Exemptions from Premarket Notification, classify devices into one of three to provide reasonable assurance of the
Guidance for Industry and CDRH Staff,’’ regulatory classes: Class I, class II, or safety and effectiveness of the device.
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![Federal Register / Vol. 81, No. 192 / Tuesday, October 4, 2016 / Rules and Regulations 68297
risks. For example, available quality requesting exemption for a method, DATES: Effective Date: November 3,
control materials may contain glucose metallic reduction, glucose (urinary, 2016.
but do not contain other reducing sugars nonquantitative) test system in a reagent FOR FURTHER INFORMATION CONTACT: Paul
(e.g., galactose, lactose). Therefore, such tablet format that is intended to measure Webster, Director, Financial
materials might not readily detect an glucosuria (glucose in urine) from the Management Division, Office of Block
issue with the device’s safety or premarket notification requirements. Grant Assistance, Office of Community
effectiveness in detecting other reducing Manufacturers of this device type must Planning and Development, Department
sugars, before causing harm. The continue to submit and receive FDA of Housing and Urban Development,
petition provided insufficient clearance of a 510(k) before marketing 451 7th Street, SW., Room 7180,
information to support the position that their device, as well as comply with all Washington, DC 20410; telephone
changes in the device that could affect other applicable requirements under the number 202–402–4563 (this is not a toll-
safety and effectiveness will either be FD&C Act. free number). Individuals with speech
readily detectable or not materially
V. Reference or hearing impairments may access this
increase risks. Moreover, changes in the
number through TTY by calling the toll-
device that could affect safety and The following reference is on display free Federal Relay Service at 800–877–
effectiveness might materially increase in the Division of Dockets Management 8339. FAX inquiries (but not comments)
the risk of injury, incorrect diagnosis, or (HFA–305), Food and Drug may be sent to Mr. Webster at 202–708–
ineffective treatment given the device Administration, 5630 Fishers Lane, Rm. 1798 (this is not a toll-free number).
type’s intended uses. The petition also 1061, Rockville, MD 20852, and is
did not provide information to the SUPPLEMENTARY INFORMATION:
available for viewing by interested
contrary. The petition did not provide persons between 9 a.m. and 4 p.m., I. Background
any information regarding the fourth Monday through Friday; it is also The Consolidated and Further
factor. available electronically at http://
In addition to these four factors, FDA Continuing Appropriations Act, 2015
www.regulations.gov. FDA has verified (Public Law 113–235, approved
considers the ‘‘limitations on the Web site address, as of the date this
exemption.’’ Manufacturers of any December 16, 2014) (2015
document publishes in the Federal Appropriations Act) provided that ‘‘the
commercially distributed device for Register, but Web sites are subject to
which FDA has granted an exemption Secretary shall collect fees from
change over time. borrowers . . . to result in a credit
from the requirement of premarket
1. ‘‘Procedures for Class II Device subsidy cost of zero for guaranteeing’’
notification must still submit a
Exemptions from Premarket Notification, Section 108 loans. The Continuing
premarket notification to FDA prior to Guidance for Industry and CDRH Staff,’’
marketing the device when any of the Appropriations Act, 2016 (Public Law
February 1998, available at http://
limitations of exemption are exceeded. 114–53, approved September 30, 2015)
www.fda.gov/downloads/
The general limitations of exemption MedicalDevices/ continued the 2015 provision. This
from premarket notification contained DeviceRegulationandGuidance/ continued funding act was followed by
in § 862.9 (21 CFR 862.9) are broadly GuidanceDocuments/UCM080199.pdf. The Consolidated Appropriations Act,
applicable to in vitro diagnostic (IVD) 2016, Public Law 114–133, approved
Dated: September 28, 2016.
devices classified under part 862 (21 December 18, 2015) (2016
Leslie Kux,
CFR part 862). Under § 862.9, the Appropriations Act), which had
Associate Commissioner for Policy. identical language regarding Section 108
exemption from the premarket
[FR Doc. 2016–23901 Filed 10–3–16; 8:45 am] credit subsidy to the 2015
notification requirements applies, in the
case of IVD devices, only to those BILLING CODE 4164–01–P Appropriations Act. The fiscal year
devices under part 862 for which 2017 HUD appropriations bills under
misdiagnosis, as a result of using the consideration in the House of
device, would not be associated with DEPARTMENT OF HOUSING AND Representatives (H.R. 5394), and the
high morbidity or mortality. FDA has URBAN DEVELOPMENT Senate (S. 2844) also have identical
previously assessed that this limitation language regarding the credit subsidy
is exceeded, and a premarket 24 CFR Part 570 for the Section 108 Program, and it is
notification is necessary to provide a expected that, when enacted, the final
reasonable assurance of the safety and [Docket No. FR–5767–N–05] fiscal year 2017 appropriations act will
effectiveness of an IVD device, when as well.
RIN 2506–AC35 On November 3, 2015, HUD
such device is intended for use in
screening or diagnosis of familial or Section 108 Loan Guarantee Program: published a final rule (80 FR 67626)
acquired genetic disorders, including Announcement of Fee To Cover Credit following a February 5, 2015 proposed
inborn errors of metabolism Subsidy Costs rule (80 FR 6470) that amended the
(§ 862.9(c)(2)) or intended for use in Section 108 Program regulations at 24
diabetes management (§ 862.9(c)(5)). AGENCY: Office of the Assistant CFR part 570 to establish additional
The copper reduction tablet test Secretary for Community Planning and procedures, including procedures for
described in the petition is intended for Development, HUD. determining the amount of the fee and
such uses and would likely exceed the ACTION: Announcement of fee. for a 30-day public comment process
limitations just described. when HUD adopts changes to the
asabaliauskas on DSK3SPTVN1PROD with RULES
Accordingly, for all of the foregoing SUMMARY: This document announces the assumptions underlying the fee
reasons, the petition failed to fee that HUD will collect from calculation or if the fee structure itself
demonstrate that a premarket borrowers of loans guaranteed under raises new considerations for borrowers.
submission is not necessary to provide HUD’s Section 108 Loan Guarantee HUD is required to collect fees from
a reasonable assurance of the safety and Program (Section 108 Program) to offset Section 108 borrowers when necessary
effectiveness of the device intended for the credit subsidy costs of the to offset the credit subsidy costs to the
such uses. Therefore, FDA is issuing guaranteed loans pursuant to Federal government to guarantee
this order denying the petition commitments awarded in FY 2017. Section 108 loans. Following
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Document Created: 2016-10-04 03:04:03
Document Modified: 2016-10-04 03:04:03
| 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 October 4, 2016. | |
| Contact | Sheila Connors, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4620, Silver Spring, MD 20993-0002, 301- 796-6181, [email protected] | |
| FR Citation | 81 FR 68295 |
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