80 FR 10586 - Medical Device Reporting: Electronic Submission Requirements; Correcting Amendments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 39 (February 27, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 39 (February 27, 2015)
| Page Range | 10586-10587 | |
| FR Document | 2015-03943 |
[Federal Register Volume 80, Number 39 (Friday, February 27, 2015)] [Rules and Regulations] [Pages 10586-10587] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-03943] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 803 [Docket No. FDA-2008-N-0393] RIN 0910-AF86 Medical Device Reporting: Electronic Submission Requirements; Correcting Amendments AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; correcting amendments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is amending its regulation regarding postmarket electronic Medical Device Reporting (eMDR) to address the unintentional removal of certain provisions of the Unique Device Identification (UDI) System regulations and to update the contact information listed in the regulations. DATES: This rule is effective August 14, 2015. FOR FURTHER INFORMATION CONTACT: Sharon Kapsch, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3208, Silver Spring, MD 20993-0002, 301-796-6104, [email protected]. SUPPLEMENTARY INFORMATION: In the Federal Register of September 24, 2013 (78 FR 58786), FDA published the ``Unique Device Identification System'' final rule (UDI rule). The UDI rule, among other things, amended part 803 (21 CFR part 803). These amendments became effective on December 23, 2013. In the Federal Register of February 14, 2014 (79 FR 8832), FDA published the ``Medical Device Reporting: Electronic Submission Requirements'' final rule (eMDR rule). The eMDR rule will become effective on August 14, 2015. The eMDR rule, among other things, revises part 803 in its entirety. As published in the Federal Register, the eMDR rule will, upon its effective date, unintentionally remove the amendments made by the UDI rule to part 803 of the Code of Federal Regulations (CFR), Title 21. This document addresses the unintentional removal by amending part 803 to include the UDI requirements. When the eMDR rule goes into effect, it will require changes to the CFR citations of some provisions within part 803; consequently, some of the citations used by the UDI rule will have to be updated. The following table provides the ``Original UDI Citation'' (the citation used by the September 24, 2013, UDI rule) and the corresponding ``Updated Citation'' for provisions addressed in this document. Table 1--Citations in Part 803; UDI Citation and Corresponding Updated Citation ---------------------------------------------------------------------------------------------------------------- Provision Original UDI citation \1\ Updated citation \2\ ---------------------------------------------------------------------------------------------------------------- Amendment of 803.3--Definitions of human cell, Listed alphabetically within 803.3(aa) and 803.3(bb), tissue, or cellular or tissue-based product (HCT/P) 803.3. respectively. regulated as a device and unique device identifier (UDI). Amendment of section 803.32.......................... 803.32(c)(6)................ 803.32(c)(4). Amendment of section 803.33.......................... 803.33(a)(7)(iv)............ 803.33(b)(7)(iv). Amendment of section 803.42.......................... 803.42(c)(6)................ 803.42(c)(4). Amendment of section 803.52.......................... 803.52(c)(6)................ 803.52(c)(4). ---------------------------------------------------------------------------------------------------------------- \1\ The ``Original UDI Citation'' is the citation within part 803, as amended by the UDI rule, which became effective on December 23, 2013. \2\ The ``Updated Citation'' is the citation within part 803, after the changes made by the eMDR rule go into effect on August 14, 2015, and after those changes are further amended by the correcting amendments in this document. We are also updating the contact information listed in Sec. Sec. 803.11 and 803.33 for the Division of International and Consumer Education (DICE) (formerly the Division of Small Manufacturers, International and Consumer Assistance (DSMICA)). FDA is publishing this document as a final rule under the Administrative Procedures Act (5 U.S.C. 551, et seq.). FDA has determined that good cause exists to dispense with prior notice and public comment under 5 U.S.C. 553(b)(3)(B) and 21 CFR 10.40(e)(1) because the provisions addressed in this document have already undergone notice and public comment. Additionally, the amendments to Sec. Sec. 803.11 and 803.33, to provide updated contact information, are editorial in nature and are intended to improve the accuracy of the Agency's regulations. FDA has determined under 21 CFR 25.30(i) that this final rule 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. This final rule 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 (the PRA). The revised Form FDA 3500A is approved under OMB control number 0910-0291. The collections of information in part 803 have been approved under OMB [[Page 10587]] control number 0910-0437. The collections of information in the UDI rule have been approved under OMB control number 0910-0720. The information collection provisions in the eMDR rule have been submitted to OMB for review as required by section 3507(d) of the PRA (44 U.S.C. 3507(d)). Before the effective date of the final rule, FDA will publish a notice in the Federal Register announcing OMB's decision to approve, modify, or disapprove the information collection provisions in the final rule. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. List of Subjects in 21 CFR Part 803 Imports, Medical devices, Reporting and recordkeeping requirements. Therefore under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 803 as amended by the Medical Device Reporting: Electronic Submission Requirements final rule of February 14, 2014, 79 FR 8832, is further amended as follows: PART 803--MEDICAL DEVICE REPORTING 0 1. The authority citation for 21 CFR part 803 continues to read as follows: Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374. 0 2. Amend Sec. 803.3 by adding paragraphs (aa) and (bb) to read as follows: Sec. 803.3 How does FDA define the terms used in this part? * * * * * (aa) Human cell, tissue, or cellular or tissue-based product (HCT/ P) regulated as a device means an HCT/P as defined in Sec. 1271.3(d) of this chapter that does not meet the criteria in Sec. 1271.10(a) and that is also regulated as a device. (bb) Unique device identifier (UDI) means an identifier that adequately identifies a device through its distribution and use by meeting the requirements of Sec. 830.20 of this chapter. A unique device identifier is composed of: (1) A device identifier--a mandatory, fixed portion of a UDI that identifies the specific version or model of a device and the labeler of that device; and (2) A production identifier--a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of the device: (i) The lot or batch within which a device was manufactured; (ii) The serial number of a specific device; (iii) The expiration date of a specific device; (iv) The date a specific device was manufactured. (v) For an HCT/P regulated as a device, the distinct identification code required by Sec. 1271.290(c) of this chapter. * * * * * 0 3. Amend Sec. 803.11 by revising paragraph (d) to read as follows: Sec. 803.11 What form should I use to submit reports of individual adverse events and where do I obtain these forms? * * * * * (d) Form FDA 3500A is available on the Internet at http://www.fda.gov/medwatch/getforms.htm or from Division of International and Consumer Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4621, Silver Spring, MD 20993-0002, by email: [email protected], FAX: 301-847- 8149, or telephone: 800-638-2041. 0 4. Amend Sec. 803.32 by revising paragraph (c)(4) to read as follows: Sec. 803.32 If I am a user facility, what information must I submit in my individual adverse event reports? * * * * * (c) * * * (4) Model number, catalog number, serial number, lot number, or other identifying number; expiration date; and unique device identifier (UDI) that appears on the device label or on the device package; * * * * * 0 5. Amend Sec. 803.33 by revising paragraphs (a)(2) and (b)(7)(iv) to read as follows: Sec. 803.33 If I am a user facility, what must I include when I submit an annual report? * * * * * (a) * * * (2) Division of International and Consumer Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4621, Silver Spring, MD 20993-0002, by email: [email protected], FAX: 301-847-8149, or telephone: 800-638- 2041. * * * * * (b) * * * (7) * * * (iv) Product model, catalog, serial, and lot number and unique device identifier (UDI) that appears on the device label or on the device package; * * * * * 0 6. Amend Sec. 803.42 by revising paragraph (c)(4) to read as follows: Sec. 803.42 If I am an importer, what information must I submit in my individual adverse event reports? * * * * * (c) * * * (4) Model number, catalog number, serial number, lot number, or other identifying number; expiration date; and unique device identifier (UDI) that appears on the device label or on the device package; * * * * * 0 7. Amend Sec. 803.52 by revising paragraph (c)(4) to read as follows: Sec. 803.52 If I am a manufacturer, what information must I submit in my individual adverse event reports? * * * * * (c) * * * (4) Model number, catalog number, serial number, lot number, or other identifying number; expiration date; and unique device identifier (UDI) that appears on the device label or on the device package; * * * * * Dated: February 20, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-03943 Filed 2-26-15; 8:45 am] BILLING CODE 4164-01-P
![10586 Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Rules and Regulations
Price, UT, Carbon County Rgnl/Buck DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION: In the
Davis Field, VOR RWY 36, Amdt 2, HUMAN SERVICES Federal Register of September 24, 2013
CANCELED (78 FR 58786), FDA published the
Price, UT, Carbon County Rgnl/Buck Food and Drug Administration ‘‘Unique Device Identification System’’
Davis Field, VOR/DME RWY 1, Amdt final rule (UDI rule). The UDI rule,
1 21 CFR Part 803 among other things, amended part 803
Effective 2 April 2015 [Docket No. FDA–2008–N–0393] (21 CFR part 803). These amendments
RIN 0910–AF86
became effective on December 23, 2013.
Truckee, CA, Truckee-Tahoe, RNAV In the Federal Register of February
(GPS) Z RWY 20, Orig–A Medical Device Reporting: Electronic 14, 2014 (79 FR 8832), FDA published
RESCINDED: On January 15, 2015 (80 Submission Requirements; Correcting the ‘‘Medical Device Reporting:
FR 2009), the FAA published an Amendments Electronic Submission Requirements’’
Amendment in Docket No. 30990, Amdt AGENCY: Food and Drug Administration, final rule (eMDR rule). The eMDR rule
No. 3619, to Part 97 of the Federal HHS. will become effective on August 14,
Aviation Regulations under section 2015. The eMDR rule, among other
Final rule; correcting
ACTION:
97.23, 97.27, and 97.29. The following things, revises part 803 in its entirety.
amendments.
entries for Baton Rouge, LA, effective As published in the Federal Register,
January 8, 2015 are hereby rescinded in SUMMARY: The Food and Drug the eMDR rule will, upon its effective
their entirety: Administration (FDA) is amending its date, unintentionally remove the
Baton Rouge, LA, Baton Rouge regulation regarding postmarket amendments made by the UDI rule to
Metropolitan, Ryan Field, ILS OR electronic Medical Device Reporting part 803 of the Code of Federal
LOC RWY 13, Amdt 27E (eMDR) to address the unintentional Regulations (CFR), Title 21. This
removal of certain provisions of the
Baton Rouge, LA, Baton Rouge document addresses the unintentional
Unique Device Identification (UDI)
Metropolitan, Ryan Field, ILS OR removal by amending part 803 to
System regulations and to update the
LOC RWY 22R, Amdt 11B contact information listed in the include the UDI requirements.
Baton Rouge, LA, Baton Rouge regulations. When the eMDR rule goes into effect,
Metropolitan, Ryan Field, NDB RWY it will require changes to the CFR
DATES: This rule is effective August 14,
31, Amdt 2D citations of some provisions within part
2015.
Baton Rouge, LA, Baton Rouge 803; consequently, some of the citations
FOR FURTHER INFORMATION CONTACT:
Metropolitan, Ryan Field, VOR RWY used by the UDI rule will have to be
Sharon Kapsch, Office of Surveillance
4L, Amdt 17C updated. The following table provides
and Biometrics, Center for Devices and
Baton Rouge, LA, Baton Rouge Radiological Health, Food and Drug the ‘‘Original UDI Citation’’ (the citation
Metropolitan, Ryan Field, VOR/DME Administration, 10903 New Hampshire used by the September 24, 2013, UDI
RWY 22R, Amdt 8H Ave., Bldg. 66, Rm. 3208, Silver Spring, rule) and the corresponding ‘‘Updated
[FR Doc. 2015–03931 Filed 2–26–15; 8:45 am] MD 20993–0002, 301–796–6104, Citation’’ for provisions addressed in
BILLING CODE 4910–13–P Sharon.Kapsch@fda.hhs.gov. this document.
TABLE 1—CITATIONS IN PART 803; UDI CITATION AND CORRESPONDING UPDATED CITATION
Provision Original UDI citation 1 Updated citation 2
Amendment of 803.3—Definitions of human cell, tissue, or cellular or tissue- Listed alphabetically within 803.3(aa) and 803.3(bb), re-
based product (HCT/P) regulated as a device and unique device identifier 803.3. spectively.
(UDI).
Amendment of section 803.32 ................................................................................. 803.32(c)(6) ........................... 803.32(c)(4).
Amendment of section 803.33 ................................................................................. 803.33(a)(7)(iv) ...................... 803.33(b)(7)(iv).
Amendment of section 803.42 ................................................................................. 803.42(c)(6) ........................... 803.42(c)(4).
Amendment of section 803.52 ................................................................................. 803.52(c)(6) ........................... 803.52(c)(4).
1 The‘‘Original UDI Citation’’ is the citation within part 803, as amended by the UDI rule, which became effective on December 23, 2013.
2 The‘‘Updated Citation’’ is the citation within part 803, after the changes made by the eMDR rule go into effect on August 14, 2015, and after
those changes are further amended by the correcting amendments in this document.
We are also updating the contact because the provisions addressed in this neither an environmental assessment
information listed in §§ 803.11 and document have already undergone nor an environmental impact statement
803.33 for the Division of International notice and public comment. is required.
and Consumer Education (DICE) Additionally, the amendments to This final rule refers to previously
(formerly the Division of Small §§ 803.11 and 803.33, to provide approved collections of information
Manufacturers, International and updated contact information, are found in FDA regulations. These
Consumer Assistance (DSMICA)). editorial in nature and are intended to collections of information are subject to
FDA is publishing this document as a improve the accuracy of the Agency’s review by the Office of Management and
tkelley on DSK3SPTVN1PROD with RULES
final rule under the Administrative regulations. Budget (OMB) under the Paperwork
Procedures Act (5 U.S.C. 551, et seq.). FDA has determined under 21 CFR Reduction Act of 1995 (the PRA). The
FDA has determined that good cause 25.30(i) that this final rule is of a type revised Form FDA 3500A is approved
exists to dispense with prior notice and that does not individually or under OMB control number 0910–0291.
public comment under 5 U.S.C. cumulatively have a significant effect on The collections of information in part
553(b)(3)(B) and 21 CFR 10.40(e)(1) the human environment. Therefore, 803 have been approved under OMB
VerDate Sep<11>2014 16:12 Feb 26, 2015 Jkt 235001 PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 E:\FR\FM\27FER1.SGM 27FER1](https://thefederalregister.org/doc/80_FR_10625/page/1.svg)
![Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Rules and Regulations 10587
control number 0910–0437. The (i) The lot or batch within which a identifier (UDI) that appears on the
collections of information in the UDI device was manufactured; device label or on the device package;
rule have been approved under OMB (ii) The serial number of a specific * * * * *
control number 0910–0720. device; ■ 6. Amend § 803.42 by revising
The information collection provisions (iii) The expiration date of a specific paragraph (c)(4) to read as follows:
in the eMDR rule have been submitted device;
to OMB for review as required by (iv) The date a specific device was § 803.42 If I am an importer, what
section 3507(d) of the PRA (44 U.S.C. manufactured. information must I submit in my individual
3507(d)). Before the effective date of the adverse event reports?
(v) For an HCT/P regulated as a
final rule, FDA will publish a notice in * * * * *
device, the distinct identification code
the Federal Register announcing OMB’s (c) * * *
required by § 1271.290(c) of this
decision to approve, modify, or (4) Model number, catalog number,
chapter.
disapprove the information collection serial number, lot number, or other
provisions in the final rule. An Agency * * * * *
identifying number; expiration date; and
may not conduct or sponsor, and a ■ 3. Amend § 803.11 by revising unique device identifier (UDI) that
person is not required to respond to, a paragraph (d) to read as follows: appears on the device label or on the
collection of information unless it device package;
displays a currently valid OMB control § 803.11 What form should I use to submit
reports of individual adverse events and * * * * *
number. where do I obtain these forms? ■ 7. Amend § 803.52 by revising
List of Subjects in 21 CFR Part 803 * * * * * paragraph (c)(4) to read as follows:
Imports, Medical devices, Reporting (d) Form FDA 3500A is available on
§ 803.52 If I am a manufacturer, what
and recordkeeping requirements. the Internet at http://www.fda.gov/ information must I submit in my individual
Therefore under the Federal Food, medwatch/getforms.htm or from adverse event reports?
Drug, and Cosmetic Act and under Division of International and Consumer
* * * * *
authority delegated to the Commissioner Education, Center for Devices and
(c) * * *
of Food and Drugs, 21 CFR part 803 as Radiological Health, Food and Drug
(4) Model number, catalog number,
amended by the Medical Device Administration, 10903 New Hampshire
serial number, lot number, or other
Reporting: Electronic Submission Ave., Bldg. 66, Rm. 4621, Silver Spring,
identifying number; expiration date; and
Requirements final rule of February 14, MD 20993–0002, by email: DICE@
unique device identifier (UDI) that
2014, 79 FR 8832, is further amended as fda.hhs.gov, FAX: 301–847–8149, or
appears on the device label or on the
follows: telephone: 800–638–2041.
device package;
■ 4. Amend § 803.32 by revising
PART 803—MEDICAL DEVICE * * * * *
paragraph (c)(4) to read as follows:
REPORTING Dated: February 20, 2015.
§ 803.32 If I am a user facility, what Leslie Kux,
■ 1. The authority citation for 21 CFR information must I submit in my individual
Associate Commissioner for Policy.
part 803 continues to read as follows: adverse event reports?
[FR Doc. 2015–03943 Filed 2–26–15; 8:45 am]
Authority: 21 U.S.C. 352, 360, 360i, 360j, * * * * *
BILLING CODE 4164–01–P
371, 374. (c) * * *
■ 2. Amend § 803.3 by adding (4) Model number, catalog number,
paragraphs (aa) and (bb) to read as serial number, lot number, or other
identifying number; expiration date; and DEPARTMENT OF THE TREASURY
follows:
unique device identifier (UDI) that
§ 803.3 How does FDA define the terms appears on the device label or on the Internal Revenue Service
used in this part? device package;
* * * * * 26 CFR Part 1
* * * * *
(aa) Human cell, tissue, or cellular or
■ 5. Amend § 803.33 by revising [TD 9712]
tissue-based product (HCT/P) regulated
paragraphs (a)(2) and (b)(7)(iv) to read as
as a device means an HCT/P as defined RIN 1545–BL78
follows:
in § 1271.3(d) of this chapter that does
not meet the criteria in § 1271.10(a) and § 803.33 If I am a user facility, what must Alternative Simplified Credit Election
that is also regulated as a device. I include when I submit an annual report?
(bb) Unique device identifier (UDI) AGENCY: Internal Revenue Service (IRS),
* * * * * Treasury.
means an identifier that adequately (a) * * *
identifies a device through its ACTION: Final regulations and removal of
(2) Division of International and
distribution and use by meeting the temporary regulations.
Consumer Education, Center for Devices
requirements of § 830.20 of this chapter. and Radiological Health, Food and Drug
A unique device identifier is composed SUMMARY: This document contains final
Administration, 10903 New Hampshire regulations relating to the election of the
of: Ave., Bldg. 66, Rm. 4621, Silver Spring,
(1) A device identifier—a mandatory, alternative simplified credit under
MD 20993–0002, by email: DICE@ section 41(c)(5) of the Internal Revenue
fixed portion of a UDI that identifies the
fda.hhs.gov, FAX: 301–847–8149, or Code (Code). The final regulations affect
specific version or model of a device
tkelley on DSK3SPTVN1PROD with RULES
telephone: 800–638–2041. certain taxpayers claiming the credit
and the labeler of that device; and
(2) A production identifier—a * * * * * under section 41.
conditional, variable portion of a UDI (b) * * * DATES: Effective Date: These regulations
that identifies one or more of the (7) * * * are effective on February 27, 2015.
following when included on the label of (iv) Product model, catalog, serial, Applicability Date: For dates of
the device: and lot number and unique device applicability, see § 1.41–9(d).
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Document Created: 2015-12-18 13:14:02
Document Modified: 2015-12-18 13:14:02
| 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 rule; correcting amendments. | |
| Dates | This rule is effective August 14, 2015. | |
| Contact | Sharon Kapsch, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3208, Silver Spring, MD 20993-0002, 301-796-6104, [email protected] | |
| FR Citation | 80 FR 10586 | |
| RIN Number | 0910-AF86 | |
| CFR Associated | Imports; Medical Devices and Reporting and Recordkeeping Requirements |
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