Medical Devices; Exemption From Premarket Notification: Powered Patient Transport, All Other Powered Patient Transport, 31722-31724 [2021-12505]

Download as PDF 31722 Federal Register / Vol. 86, No. 113 / Tuesday, June 15, 2021 / Notices intended to support the approval of NADAs, ANADAs, or applications for conditional approval (for example, animal drug sponsor, test facility, developer, vendor, user of electronic data capture (EDC) and data visualization software, or study data quality control (QC) and quality assurance (QA) specialist). DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–N–0390] Lederle Laboratories et al.; Withdrawal of Approval of 12 Abbreviated New Drug Applications; Correction khammond on DSKJM1Z7X2PROD with NOTICES II. Other Issues for Consideration AGENCY: CVM seeks to continuously enhance review efficiency and interactions with the animal health industry. As part of our continued effort to engage with the animal health industry, we are interested in understanding more about the experiences and familiarity of those involved in animal drug development with the use of data exchange standards. We specifically request public comment regarding the questions below. When submitting comments, it would help us if commenters would identify their animal health industry sector (for example, animal drug sponsor, test facility, developer, vendor, user of EDC and data visualization software, or study data QC and QA specialist). We will consider the comments as we evaluate the potential use of study data exchange standards for animal studies submitted as part of the new animal drug approval process. 1. Which study data exchange standards are you currently using, if any, for the submission of study data to CVM; and which tools do you use to review, analyze, or validate the study data? 2. If study data exchange standards are included as part of your study data management process, when are they incorporated (for example, in protocol development, EDC database and case report form development, post-study processing)? 3. What are the potential benefits or anticipated challenges to the animal health industry of harmonizing CVM’s data exchange standards expectations with other FDA Centers’ expectations? 4. What can CVM do to help industry to be more prepared for, or to reduce the burden of implementing, the use of study data exchange standards? 5. What other comments do you have regarding the use of study data exchange standards for submission of study data to CVM? Dated: June 8, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–12503 Filed 6–14–21; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 17:02 Jun 14, 2021 Jkt 253001 Food and Drug Administration, HHS. ACTION: Notice; correction. The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on May 12, 2021. The document announced the withdrawal of approval of 12 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of June 11, 2021. The document indicated that FDA was withdrawing the approval of ANDA 060164, Nystatin Ointment, held by Lederle Laboratories. However, the document published with an incorrect application number for this product. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993–0002, 240– 402–6980, Martha.Nguyen@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In the Federal Register of Wednesday, May 12, 2021 (86 FR 26058), appearing on page 26058 in FR Doc. 2021–09980, the following correction is made: On page 26058, in the first column, in the first line in the table, the application number ‘‘060164’’ is corrected to read ‘‘061064’’. SUMMARY: Dated: June 8, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–12557 Filed 6–14–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–N–0493] Medical Devices; Exemption From Premarket Notification: Powered Patient Transport, All Other Powered Patient Transport AGENCY: Food and Drug Administration, HHS. ACTION: PO 00000 Notice. Frm 00030 Fmt 4703 Sfmt 4703 The Food and Drug Administration (FDA or Agency) is announcing that it has received a petition requesting exemption from the premarket notification requirements for the generic device type, powered patient transport, all other powered patient transport. These devices are motorized devices used to mitigate mobility impairment caused by injury or other disease by moving a person from one location or level to another, such as up and down flights of stairs. This device type does not include motorized threewheeled vehicles or wheelchairs, and is distinct from the device type, powered patient transport, powered patient stairway chair lifts, which is classified separately within the same regulation. FDA is publishing this notice to obtain comments in accordance with procedures established by the Federal Food, Drug, and Cosmetic Act (FD&C Act). DATES: Submit either electronic or written comments by August 16, 2021. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before August 16, 2021. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of August 16, 2021. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you E:\FR\FM\15JNN1.SGM 15JNN1 Federal Register / Vol. 86, No. 113 / Tuesday, June 15, 2021 / Notices khammond on DSKJM1Z7X2PROD with NOTICES do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2021–N–0493 for ‘‘Medical Devices; Exemption from Premarket Notification: Powered Patient Transport, All Other Powered Patient Transport.’’ Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff office between 9 a.m. and 4 p.m., Monday through Friday, 240–402–7500. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on 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 comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access VerDate Sep<11>2014 17:02 Jun 14, 2021 Jkt 253001 the information at: https:// www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to 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, 240–402–7500. FOR FURTHER INFORMATION CONTACT: Dan Reed, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1526, Silver Spring, MD 20993–0002, 240–402–4717. SUPPLEMENTARY INFORMATION: I. Regulatory Background Under section 513 of the FD&C Act (21 U.S.C. 360c), FDA classifies 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 safety and effectiveness. Pursuant to section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and the implementing regulations, part 807 (21 CFR part 807), persons who intend to market a new device are required to submit and obtain 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 to a legally marketed device that does not require premarket approval. On November 21, 1997, section 206 of the Food and Drug Administration Modernization Act (Pub. L. 105–115) added new section 510(m) to the FD&C Act. On December 13, 2016, section 3054 of the 21st Century Cures Act (Pub. L. 114–255) (Cures Act) amended section 510(m) of the FD&C Act. As amended, section 510(m)(1) of the FD&C Act requires FDA, within 90 days after enactment of the Cures Act and once every 5 years thereafter, 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. As amended by the Cures Act, section 510(m)(2) of the FD&C Act provides that, 1 calendar day after the date of publication of the final list mentioned in section 510(m)(1)(B), FDA may exempt a class II device from the requirement to submit a report under PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 31723 section 510(k) of the FD&C Act, upon its own initiative or receipt of a petition from an interested person, if FDA determines that a report under section 510(k) is not necessary to assure the safety and effectiveness of the device. To do so, FDA must publish in the Federal Register notice of its intent to exempt the device, or the petition, and provide a 60-calendar day period for public comment. Within 120 days after the issuance of this 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. The generic device type, powered patient transport is classified under § 890.5150 (21 CFR 890.5150). On March 4, 2013, in response to a petition, FDA created a separate classification for powered patient stairway chair lifts (§ 890.5150(a)), providing a conditional exemption from premarket notification for this device type, product code PCD (78 FR 14015). The classification change retained premarket notification requirements for all other powered patient transport, product code ILK (§ 890.5150(b)). 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’’ (available at http:// www.fda.gov/downloads/ MedicalDevices/DeviceRegulationand Guidance/Guidance6Documents/ UCM080199.pdf). As discussed in the guidance document, FDA generally considers the following factors to determine whether a report under section 510(k) is necessary for class II devices: (1) The device does not have a significant history of false or misleading claims or of 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 E:\FR\FM\15JNN1.SGM 15JNN1 31724 Federal Register / Vol. 86, No. 113 / Tuesday, June 15, 2021 / Notices 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 general limitations on exemptions. IV. Paperwork Reduction Act of 1995 While this notice contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501– 3521) is not required for this notice. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910–0120. Name of Committee: Center for Scientific Review Special Emphasis Panel; Renal/ Urological Small Business Activities. Date: July 8, 2021. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Santanu Banerjee, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institute of Health, 6701 Rockledge Drive, Room 2106, Bethesda, MD 20892, (301) 435–5947, banerjees5@mail.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Speech, Language and Communication. Date: July 9, 2021. Time: 11:00 a.m. to 8:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Sara Louise Hargrave, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institute of Health, 6701 Rockledge Drive, Room 3170, Bethesda, MD 20892, (301) 443–7193, hargravesl@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: June 7, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. Dated: June 10, 2021. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–12505 Filed 6–14–21; 8:45 am] [FR Doc. 2021–12510 Filed 6–14–21; 8:45 am] BILLING CODE 4164–01–P BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institutes of Health Center for Scientific Review; Notice of Closed Meetings National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings III. Proposed Class II Device Exemptions FDA has received the following petition requesting an exemption from premarket notification for a class II device: Sam DeMarco, Staff Regulatory Affairs Specialist, on behalf of Stryker Medical, 3800 E Centre Ave., Portage, MI 49002, for powered patient transport, all other powered patient transport, classified under § 890.5150(b). FDA seeks comment on the petition in accordance with section 510(m)(2) of the FD&C Act. khammond on DSKJM1Z7X2PROD with NOTICES applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant VerDate Sep<11>2014 17:02 Jun 14, 2021 Jkt 253001 Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; Investigator Initiated Extended Clinical Trial (R01); NIAID Clinical Trial Planning Grant (R34); NIAID Clinical Trial Implementation Cooperative Agreement (U01); NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44). Date: June 28, 2021. Time: 12:30 p.m. to 4:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, Room 3F58, Rockville, MD 20892 (Virtual Meeting). Contact Person: Mario Cerritelli, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, Room 3F58, Rockville, MD 20852, 240–669–5199, cerritem@ mail.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; Investigator Initiated Extended Clinical Trial (R01); NIAID Clinical Trial Planning Grant (R34); NIAID Clinical Trial Implementation Cooperative Agreement (U01); NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44). Date: June 29, 2021. Time: 11:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, Room 3F58, Rockville, MD 20892 (Virtual Meeting). Contact Person: Mario Cerritelli, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, Room 3F58, Rockville, MD 20852, 240–669–5199, cerritem@ mail.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Dated: June 9, 2021. Tyeshia M. Roberson, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–12451 Filed 6–14–21; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\15JNN1.SGM 15JNN1

Agencies

[Federal Register Volume 86, Number 113 (Tuesday, June 15, 2021)]
[Notices]
[Pages 31722-31724]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-12505]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0493]


Medical Devices; Exemption From Premarket Notification: Powered 
Patient Transport, All Other Powered Patient Transport

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
that it has received a petition requesting exemption from the premarket 
notification requirements for the generic device type, powered patient 
transport, all other powered patient transport. These devices are 
motorized devices used to mitigate mobility impairment caused by injury 
or other disease by moving a person from one location or level to 
another, such as up and down flights of stairs. This device type does 
not include motorized three-wheeled vehicles or wheelchairs, and is 
distinct from the device type, powered patient transport, powered 
patient stairway chair lifts, which is classified separately within the 
same regulation. FDA is publishing this notice to obtain comments in 
accordance with procedures established by the Federal Food, Drug, and 
Cosmetic Act (FD&C Act).

DATES: Submit either electronic or written comments by August 16, 2021.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before August 16, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of August 16, 2021. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

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

[[Page 31723]]

do not wish to be made available to the public, submit the comment as a 
written/paper submission and in the manner detailed (see ``Written/
Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2021-N-0493 for ``Medical Devices; Exemption from Premarket 
Notification: Powered Patient Transport, All Other Powered Patient 
Transport.'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff office between 
9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on 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 comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to 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, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Dan Reed, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1526, Silver Spring, MD 20993-0002, 240-402-4717.

SUPPLEMENTARY INFORMATION:

I. Regulatory Background

    Under section 513 of the FD&C Act (21 U.S.C. 360c), FDA classifies 
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 safety and 
effectiveness. Pursuant to section 510(k) of the FD&C Act (21 U.S.C. 
360(k)) and the implementing regulations, part 807 (21 CFR part 807), 
persons who intend to market a new device are required to submit and 
obtain 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 to a legally marketed device that does not require 
premarket approval.
    On November 21, 1997, section 206 of the Food and Drug 
Administration Modernization Act (Pub. L. 105-115) added new section 
510(m) to the FD&C Act. On December 13, 2016, section 3054 of the 21st 
Century Cures Act (Pub. L. 114-255) (Cures Act) amended section 510(m) 
of the FD&C Act. As amended, section 510(m)(1) of the FD&C Act requires 
FDA, within 90 days after enactment of the Cures Act and once every 5 
years thereafter, 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.
    As amended by the Cures Act, section 510(m)(2) of the FD&C Act 
provides that, 1 calendar day after the date of publication of the 
final list mentioned in section 510(m)(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 receipt of a petition from an 
interested person, if FDA determines that a report under section 510(k) 
is not necessary to assure the safety and effectiveness of the device. 
To do so, FDA must publish in the Federal Register notice of its intent 
to exempt the device, or the petition, and provide a 60-calendar day 
period for public comment. Within 120 days after the issuance of this 
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.
    The generic device type, powered patient transport is classified 
under Sec.  890.5150 (21 CFR 890.5150). On March 4, 2013, in response 
to a petition, FDA created a separate classification for powered 
patient stairway chair lifts (Sec.  890.5150(a)), providing a 
conditional exemption from premarket notification for this device type, 
product code PCD (78 FR 14015). The classification change retained 
premarket notification requirements for all other powered patient 
transport, product code ILK (Sec.  890.5150(b)).

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'' (available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Guidance6Documents/UCM080199.pdf).
    As discussed in the guidance document, FDA generally considers the 
following factors to determine whether a report under section 510(k) is 
necessary for class II devices: (1) The device does not have a 
significant history of false or misleading claims or of 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

[[Page 31724]]

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 general limitations on exemptions.

III. Proposed Class II Device Exemptions

    FDA has received the following petition requesting an exemption 
from premarket notification for a class II device: Sam DeMarco, Staff 
Regulatory Affairs Specialist, on behalf of Stryker Medical, 3800 E 
Centre Ave., Portage, MI 49002, for powered patient transport, all 
other powered patient transport, classified under Sec.  890.5150(b). 
FDA seeks comment on the petition in accordance with section 510(m)(2) 
of the FD&C Act.

IV. Paperwork Reduction Act of 1995

    While this notice contains no collection of information, it does 
refer to previously approved FDA collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this notice. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in part 807, subpart E, regarding premarket notification 
submissions, have been approved under OMB control number 0910-0120.

    Dated: June 7, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-12505 Filed 6-14-21; 8:45 am]
BILLING CODE 4164-01-P