81 FR 52441 - Deciding When To Submit a 510(k) for a Software Change to an Existing Device; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 152 (August 8, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 152 (August 8, 2016)
| Page Range | 52441-52443 | |
| FR Document | 2016-18714 |
[Federal Register Volume 81, Number 152 (Monday, August 8, 2016)] [Notices] [Pages 52441-52443] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-18714] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0453] Deciding When To Submit a 510(k) for a Software Change to an Existing Device; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Deciding When to Submit a 510(k) for a Software Change to an Existing Device.'' FDA is issuing this draft guidance document to clarify when a software change in a legally marketed medical device would require that a manufacturer submit a premarket notification (510(k)) to FDA. This draft guidance is not final nor is it in effect at this time. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by November 7, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: [[Page 52442]] Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2011-D-0453 for ``Deciding When to Submit a 510(k) for a Software Change to an Existing Device.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. An electronic copy of the guidance document is available for download from the Internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the draft guidance document entitled ``Deciding When to Submit a 510(k) for a Software Change to an Existing Device'' to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002; or to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: Linda Ricci, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1314, Silver Spring, MD 20993-0002, 301-796-6325, [email protected]; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402- 7911. SUPPLEMENTARY INFORMATION: I. Background A premarket notification (510(k)) is required when a legally marketed device subject to 510(k) requirements is about to be significantly changed or modified in design, components, method of manufacture, or intended use. Significant changes or modifications are those that could significantly affect the safety or effectiveness of the device, or those that constitute major changes or modifications in the intended use of the device (21 CFR 807.81(a)(3)). This guidance, when finalized, will aid manufacturers of medical devices who intend to make a software modification to a 510(k)-cleared device or a preamendments device subject to 510(k) (i.e., ``existing devices'') during the process of deciding whether the software modification exceeds the regulatory threshold of Sec. 807.81(a)(3) for submission and clearance of a new 510(k). This draft guidance specifically addresses software design and technology modifications. This draft guidance does not apply to software for which the Agency has stated in guidance that it does not intend to enforce compliance with applicable regulatory controls (see, e.g., ``Mobile Medical Applications: Guidance for Industry and FDA Staff,'' issued February 9, 2015, available on the Internet at http://www.fda.gov/downloads/MedicalDevices/.../UCM263366.pdf). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document entitled ``Deciding When to Submit a 510(k) for a Change to an Existing Device,'' to aid manufacturers of medical devices who intend to make non-software changes to an existing device during the process of deciding whether the modification exceeds the regulatory threshold of Sec. 807.81(a)(3) for submission and clearance of a new 510(k). II. Significance of Guidance This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on when to submit a 510(k) for a software change to an existing device. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. III. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the Internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or http://www.regulations.gov. Persons unable to download an electronic copy of ``Deciding When to Submit a 510(k) for a Software Change to an Existing Device'' may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1500055 to identify the guidance you are requesting. [[Page 52443]] IV. Paperwork Reduction Act of 1995 This draft guidance 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 820 are approved under OMB control number 0910-0073; the collections of information in 21 CFR part 807, subpart E are approved under OMB control number 0910-0120; the collections of information in 21 CFR part 803 are approved under OMB control number 0910-0437; and the collections of information in 21 CFR parts 801 are approved under OMB control number 0910-0485. Dated: August 2, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-18714 Filed 8-5-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Notices 52441
21 CFR 10.25(a) and 10.30. Section effectiveness reasons, the Agency will FDA has become aware that the drug
314.161(d) provides that if FDA initiate proceedings that could result in products listed in the table in this
determines that a listed drug was the withdrawal of approval of the document are no longer being marketed.
withdrawn from sale for safety or ANDAs that refer to the listed drug.
Active ingre- Dosage form/
Application No. Drug name Strength(s) Applicant
dient(s) route
NDA 007961 ....... BENTYL ........... Dicyclomine Hy- 10 milligrams (mg)/5 milliliters Syrup; Oral ....... Aptalis Pharma US, Inc.
drochloride (mL).
(HCl).
NDA 011721 ....... NEPTAZANE ... Methazolamide 25 mg; 50 mg ............................. Tablet; Oral ...... Lederle Laboratories.
NDA 016418 ....... INDERAL ......... Propranolol HCl 10 mg; 20 mg; 40 mg; 60 mg .... Tablet; Oral ...... Wyeth Pharmaceuticals, Inc., a
subsidiary of Pfizer Inc.
NDA 021410 ....... AVANDAMET ... Metformin HCl; 500 mg/Equivalent to (EQ) 2 mg Tablet; Oral ...... SmithKline Beecham (Cork) Ltd,
Rosiglitazone base; 500 mg/EQ 4 mg base; Ireland.
Maleate. 1 g/EQ 2 mg base; 1 g/EQ 4
mg base.
NDA 021494 ....... AXID ................. Nizatidine ......... 15 mg/mL ................................... Solution; Oral ... Braintree Laboratories, Inc.
NDA 050505 ....... GARAMYCIN ... Gentamicin Sul- EQ 2 mg base/mL ...................... Injectable; Schering-Plough Corp.
fate. Intrathecal.
ANDA 061716 .... GARAMYCIN ... Gentamicin Sul- EQ 1 mg base/mL; EQ 40 mg Injectable; Injec- Schering-Plough Corp.
fate. base/mL. tion.
ANDA 061739 .... GARAMYCIN ... Gentamicin Sul- EQ 10 mg base/mL .................... Injectable; Injec- Schering-Plough Corp.
fate. tion.
ANDA 080745 .... ARISTOCORT Triamcinolone 0.5% ........................................... Ointment; Top- Astellas Pharma US, Inc.
and Acetonide. ical.
ARISTOCOR-
T A.
ANDA 083944 .... KENALOG ........ Triamcinolone 0.5% ........................................... Ointment; Top- Delcor Asset Corp.
Acetonide. ical.
FDA has reviewed its records and, DEPARTMENT OF HEALTH AND ADDRESSES: You may submit comments
under § 314.161, has determined that HUMAN SERVICES as follows:
the drug products listed in this Electronic Submissions
document were not withdrawn from Food and Drug Administration
sale for reasons of safety or Submit electronic comments in the
[Docket No. FDA–2011–D–0453]
effectiveness. Accordingly, the Agency following way:
will continue to list the drug products Deciding When To Submit a 510(k) for • Federal eRulemaking Portal: http://
listed in this document in the a Software Change to an Existing www.regulations.gov. Follow the
Device; Draft Guidance for Industry instructions for submitting comments.
‘‘Discontinued Drug Product List’’
and Food and Drug Administration Comments submitted electronically,
section of the Orange Book. The
Staff; Availability including attachments, to http://
‘‘Discontinued Drug Product List’’ www.regulations.gov will be posted to
identifies, among other items, drug AGENCY: Food and Drug Administration, the docket unchanged. Because your
products that have been discontinued HHS. comment will be made public, you are
from marketing for reasons other than ACTION: Notice of availability. solely responsible for ensuring that your
safety or effectiveness. comment does not include any
Approved ANDAs that refer to the SUMMARY: The Food and Drug confidential information that you or a
NDAs and ANDAs listed in this Administration (FDA or Agency) is third party may not wish to be posted,
document are unaffected by the announcing the availability of the draft such as medical information, your or
guidance entitled ‘‘Deciding When to anyone else’s Social Security number, or
discontinued marketing of the products
Submit a 510(k) for a Software Change confidential business information, such
subject to those NDAs and ANDAs.
to an Existing Device.’’ FDA is issuing as a manufacturing process. Please note
Additional ANDAs that refer to these this draft guidance document to clarify
products may also be approved by the that if you include your name, contact
when a software change in a legally information, or other information that
Agency if they comply with relevant marketed medical device would require
legal and regulatory requirements. If identifies you in the body of your
that a manufacturer submit a premarket comments, that information will be
FDA determines that labeling for these notification (510(k)) to FDA. This draft posted on http://www.regulations.gov.
drug products should be revised to meet guidance is not final nor is it in effect • If you want to submit a comment
current standards, the Agency will at this time. with confidential information that you
advise ANDA applicants to submit such DATES: Although you can comment on do not wish to be made available to the
labeling. any guidance at any time (see 21 CFR
mstockstill on DSK3G9T082PROD with NOTICES
public, submit the comment as a
Dated: August 2, 2016. 10.115(g)(5)), to ensure that the Agency written/paper submission and in the
Leslie Kux, considers your comment of this draft manner detailed (see ‘‘Written/Paper
guidance before it begins work on the Submissions’’ and ‘‘Instructions’’).
Associate Commissioner for Policy.
final version of the guidance, submit
[FR Doc. 2016–18707 Filed 8–5–16; 8:45 am]
either electronic or written comments Written/Paper Submissions
BILLING CODE 4164–01–P on the draft guidance by November 7, Submit written/paper submissions as
2016. follows:
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![Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Notices 52443
IV. Paperwork Reduction Act of 1995 ADDRESSES: You may submit comments copies total. One copy will include the
This draft guidance refers to as follows: information you claim to be confidential
previously approved collections of with a heading or cover note that states
Electronic Submissions
information found in FDA regulations. ‘‘THIS DOCUMENT CONTAINS
Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
These collections of information are
following way: Agency will review this copy, including
subject to review by the Office of • Federal eRulemaking Portal: http://
Management and Budget (OMB) under the claimed confidential information, in
www.regulations.gov. Follow the its consideration of comments. The
the Paperwork Reduction Act of 1995 instructions for submitting comments.
(44 U.S.C. 3501–3520). The collections second copy, which will have the
Comments submitted electronically, claimed confidential information
of information in 21 CFR part 820 are including attachments, to http://
approved under OMB control number redacted/blacked out, will be available
www.regulations.gov will be posted to for public viewing and posted on http://
0910–0073; the collections of the docket unchanged. Because your
information in 21 CFR part 807, subpart www.regulations.gov. Submit both
comment will be made public, you are copies to the Division of Dockets
E are approved under OMB control solely responsible for ensuring that your
number 0910–0120; the collections of Management. If you do not wish your
comment does not include any name and contact information to be
information in 21 CFR part 803 are confidential information that you or a
approved under OMB control number made publicly available, you can
third party may not wish to be posted, provide this information on the cover
0910–0437; and the collections of such as medical information, your or
information in 21 CFR parts 801 are sheet and not in the body of your
anyone else’s Social Security number, or comments and you must identify this
approved under OMB control number confidential business information, such
0910–0485. information as ‘‘confidential.’’ Any
as a manufacturing process. Please note
Dated: August 2, 2016.
information marked as ‘‘confidential’’
that if you include your name, contact
will not be disclosed except in
Leslie Kux, information, or other information that
accordance with 21 CFR 10.20 and other
Associate Commissioner for Policy. identifies you in the body of your
applicable disclosure law. For more
[FR Doc. 2016–18714 Filed 8–5–16; 8:45 am] comments, that information will be
information about FDA’s posting of
BILLING CODE 4164–01–P posted on http://www.regulations.gov.
• If you want to submit a comment comments to public dockets, see 80 FR
with confidential information that you 56469, September 18, 2015, or access
do not wish to be made available to the the information at: http://www.fda.gov/
DEPARTMENT OF HEALTH AND
public, submit the comment as a regulatoryinformation/dockets/
HUMAN SERVICES
written/paper submission and in the default.htm.
Food and Drug Administration manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
[Docket No. FDA-2016-D-2021] Submissions’’ and ‘‘Instructions’’). read background documents or the
electronic and written/paper comments
Written/Paper Submissions
Deciding When To Submit a 510(k) for received, go to http://
a Change to an Existing Device; Draft Submit written/paper submissions as www.regulations.gov and insert the
Guidance for Industry and Food and follows: docket number, found in brackets in the
Drug Administration Staff; Availability • Mail/Hand delivery/Courier (for heading of this document, into the
written/paper submissions): Division of ‘‘Search’’ box and follow the prompts
AGENCY: Food and Drug Administration, Dockets Management (HFA–305), Food and/or go to the Division of Dockets
HHS. and Drug Administration, 5630 Fishers Management, 5630 Fishers Lane, Rm.
ACTION: Notice of availability. Lane, Rm. 1061, Rockville, MD 20852. 1061, Rockville, MD 20852.
• For written/paper comments
SUMMARY: The Food and Drug submitted to the Division of Dockets An electronic copy of the guidance
Administration (FDA or Agency) is Management, FDA will post your document is available for download
announcing the availability of the draft comment, as well as any attachments, from the Internet. See the
guidance entitled ‘‘Deciding When to except for information submitted, SUPPLEMENTARY INFORMATION section for
Submit a 510(k) for a Change to an marked and identified, as confidential, information on electronic access to the
Existing Device.’’ FDA is issuing this if submitted as detailed in guidance. Submit written requests for a
draft guidance document to clarify ‘‘Instructions.’’ single hard copy of the draft guidance
when a change in a legally marketed Instructions: All submissions received document entitled ‘‘Deciding When to
medical device would require that a must include the Docket No. Submit a 510(k) for a Change to an
manufacturer submit a premarket FDA-2016-D-2021 for ‘‘Deciding When Existing Device’’ to the Office of the
notification (510(k)) to FDA. When to Submit a 510(k) for a Change to an Center Director, Guidance and Policy
finalized, this document will supersede Existing Device.’’ Received comments Development, Center for Devices and
‘‘Deciding When to Submit a 510(k) for will be placed in the docket and, except Radiological Health, Food and Drug
a Change to an Existing Device’’ issued for those submitted as ‘‘Confidential Administration, 10903 New Hampshire
January 10, 1997. This draft guidance is Submissions,’’ publicly viewable at Ave., Bldg. 66, Rm. 5431, Silver Spring,
not final nor is it in effect at this time. http://www.regulations.gov or at the MD 20993–0002; or the Office of
DATES: Although you can comment on Division of Dockets Management Communication, Outreach, and
any guidance at any time (see 21 CFR between 9 a.m. and 4 p.m., Monday Development, Center for Biologics
mstockstill on DSK3G9T082PROD with NOTICES
10.115(g)(5)), to ensure that the Agency through Friday. Evaluation and Research, Food and
considers your comment of this draft • Confidential Submissions—To Drug Administration, 10903 New
guidance before it begins work on the submit a comment with confidential Hampshire Ave., Bldg. 71, Rm. 3128,
final version of the guidance, submit information that you do not wish to be Silver Spring, MD 20993–0002. Send
either electronic or written comments made publicly available, submit your one self-addressed adhesive label to
on the draft guidance by November 7, comments only as a written/paper assist that office in processing your
2016. submission. You should submit two request.
VerDate Sep<11>2014 22:23 Aug 05, 2016 Jkt 238001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\08AUN1.SGM 08AUN1](https://thefederalregister.org/doc/81_FR_52593/page/3.svg)
Document Created: 2016-08-06 03:08:19
Document Modified: 2016-08-06 03:08:19
| 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 | Notices | |
| Action | Notice of availability. | |
| Dates | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by November 7, 2016. | |
| Contact | Linda Ricci, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1314, Silver Spring, MD 20993-0002, 301-796-6325, [email protected]; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402- 7911. | |
| FR Citation | 81 FR 52441 |
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