[Federal Register Volume 85, Number 64 (Thursday, April 2, 2020)]
[Rules and Regulations]
[Pages 18439-18444]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06354]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 5, 801, 803, 807, 814, 820, 821, 822, 830, 860, 884,
900, and 1002
[Docket No. FDA-2020-N-0011]
Medical Devices; Technical Amendments
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendments.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
amending its medical device regulations. These revisions are necessary
to reflect changes to the Agency's Center for Devices and Radiological
Health's organizational structure, including the reorganization of its
offices. The revisions replace references to the obsolete offices and
positions with the current information, update the physical addresses
for such offices, and correct inaccurate citations. In addition, as
part of this effort we made other editorial non-substantive changes to
correct other addresses, references, and citations, as appropriate. The
rule does not impose any new regulatory requirements on affected
parties. This action is editorial in nature and is intended to improve
the accuracy of the Agency's regulations.
DATES: This rule is effective April 1, 2020.
FOR FURTHER INFORMATION CONTACT: Madhusoodana Nambiar, Office of
Policy, Center for Devices and Radiological Health, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5519, Silver Spring, MD 20993-0002, 301-796-5837.
SUPPLEMENTARY INFORMATION:
I. Background
The FDA Center for Devices and Radiological Health (CDRH) has
reorganized (84 FR 22854, May 20, 2019) to create an agile
infrastructure that can adapt to future organizational, regulatory, and
scientific needs. The goal of this change is to implement more
efficient, consistent work processes across CDRH that better support
and advance CDRH's public health mission and vision. The reorganization
will integrate CDRH's premarket and postmarket program functions along
product lines, allowing experts to leverage their knowledge to optimize
decision making across the product life cycle. Implementation took a
phased approach starting on March 18, 2019, and was completed on
September 30, 2019.
Historically, CDRH has been organized according to the stage of the
product's life cycle, e.g., premarket review, postmarket surveillance,
and compliance, rather than by the type of product regulated. The
reorganization integrates these functions by product type within the
Office of Product Evaluation and Quality (OPEQ). OPEQ was formed by
combining the Office of Compliance, the Office of Device Evaluation,
the Office of Surveillance and Biometrics, and the Office of In Vitro
Diagnostics and Radiological Health into one super office focused on a
Total Product Lifecycle approach to medical device oversight. Within
OPEQ, there are offices divided by product type, referred to as Offices
of Health Technology (OHT), as well as cross-cutting offices focusing
on specific policy and programmatic needs including the Office of
Regulatory Programs and the Office of Clinical Evidence and Analysis.
In addition, the reorganization established the Office of Policy, which
includes two teams, the Guidance, Legislation and Special Projects Team
and the Regulatory Documents and Special Projects Team, with no changes
in the functions for CDRH Policy. The reorganization also established
the Office of Strategic Partnerships and Technology Innovation (OST),
which combined the Science and Strategic Partnerships, Digital Health,
Health Informatics and Innovation teams. There are no changes in
functions within the different OST teams. CDRH reorganization also
realigned Management Services within the Center to ensure
administrative functions in CDRH are optimally aligned, structured, and
deliver excellent service. The reorganization streamlined the Center's
communication functions, by combining the internal and external
communication functions, including CDRH Executive Secretary and Speaker
Liaison, into the renamed Division of Communication in the Office of
Communication and Education, and created an Internal Communication
Branch. The structure of the Office of Science and Engineering
Laboratories remains unchanged.
As part of this effort, we are also making other editorial non-
substantive changes to correct other addresses, references, and
citations, as appropriate.
II. Description of the Technical Amendments
The regulations specified in this rule have been revised to replace
all references to ``Office of Device Evaluation'', ``Office of
Compliance'', ``Office of Surveillance and Biometrics'' with ``Office
of Product Evaluation and Quality,'' and where, appropriate, we have
used the term ``Office,'' ``Division,'' ``Team'' or ``Office of Health
Technology'' to reflect the responsible unit within CDRH. We have also
made conforming edits, as appropriate. In addition, because of the
reorganization, the physical location for many of the offices changed,
and thus, we have made non-substantive amendments to ensure that the
room numbers and addresses reflect the current information, and other
changes as necessary to update outdated addresses, references, and
citations in the regulations pertaining to medical devices. The rule
does not impose any new regulatory requirements on affected parties.
The amendments are editorial in nature and should not be construed as
modifying any substantive standards or requirements.
III. Notice and Public Comment
Publication of this document constitutes final action of these
changes under the Administrative Procedure Act (5 U.S.C. 553). Section
553 of the Administrative Procedure Act (APA) exempts ``rules of agency
organization, procedure, or practice'' from proposed rulemaking (i.e.,
notice and comment rulemaking). 5 U.S.C. 553(b)(3)(A). Rules are also
exempt when an agency finds ``good cause'' that notice and comment
rulemaking procedures would be ``impracticable, unnecessary, or
contrary to the public interest.'' 5 U.S.C. 553(b)(3)(B).
FDA has determined that this rulemaking meets the notice and
comment exemption requirements in 5 U.S.C. 553(b)(3)(A) and (B). FDA's
revisions make technical or non-substantive changes that pertain solely
to the CDRH reorganization and office move and do not alter any
substantive
[[Page 18440]]
standard. FDA does not believe public comment is necessary for these
minor revisions.
The APA allows an effective date less than 30 days after
publication as ``provided by the agency for good cause found and
published with the rule'' (5 U.S.C. 553(d)(3)). A delayed effective
date is unnecessary in this case because the amendments do not impose
any new regulatory requirements on affected parties. As a result,
affected parties do not need time to prepare before the rule takes
effect. Therefore, FDA finds good cause for the amendments to become
effective on the date of publication of this action.
List of Subjects
21 CFR Part 5
Authority delegations (Government agencies), Imports, Organization
and functions (Government agencies).
21 CFR Part 801
Labeling, Medical devices, Reporting and recordkeeping
requirements.
21 CFR Parts 803 and 821
Imports, Medical devices, Reporting and recordkeeping requirements.
21 CFR Part 807
Confidential business information, Imports, Medical devices,
Reporting and recordkeeping requirements.
21 CFR Part 814
Administrative practice and procedure, Confidential business
information, Medical devices, Medical research, Reporting and
recordkeeping requirements.
21 CFR Parts 820 and 822
Medical devices, Reporting and recordkeeping requirements.
21 CFR Part 830
Administrative practice and procedure, Labeling, Medical devices,
Reporting and recordkeeping requirements.
21 CFR Part 860
Administrative practice and procedure, Medical devices.
21 CFR Part 884
Medical Devices.
21 CFR Part 900
Electronic products, Health facilities, Medical devices, Radiation
protection, Reporting and recordkeeping requirements, X-rays.
21 CFR Part 1002
Electronic products, Radiation protection, Reporting and
recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
the authority delegated to the Commissioner of Food and Drugs, 21 CFR
parts 5, 801, 803, 807, 814, 820, 821, 822, 830, 860, 884, 900, and
1002 are amended as follows:
PART 5--ORGANIZATION
0
1. The authority citation for part 5 continues to read as follows:
Authority: 5 U.S.C. 552; 21 U.S.C. 301-397.
0
2. In Sec. 5.1100, revise the entries for ``Center for Devices and
Radiological Health'' through ``Office of In Vitro Diagnostics and
Radiological Health'' to read as follows:
Sec. 5.1100 Headquarters.
* * * * *
Center for Devices and Radiological Health.\12\
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\12\ Mailing address: 10903 New Hampshire Ave., Bldg. 66, Silver
Spring, MD 20993.
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Office of the Center Director.
Quality Management Staff.
Office of Communication and Education.
Digital Communication Media Staff.
Program Management Operations Staff.
Division of Communication.
External Communications Branch.
Web and Graphics Branch.
Internal Communication Branch.
Division of Employee Training and Development.
Employee Development Branch.
Technology and Learning Management Branch.
Division of Industry and Consumer Education.
Premarket Programs Branch.
Postmarket and Consumer Branch.
Division of Information Disclosure.
Freedom of Information Branch A.
Freedom of Information Branch B.
Office of Management.
Planning and Program Analysis Staff.
Division of Acquisition Services.
Advanced Acquisitions.
Simplified Acquisitions.
Acquisition Planning Assistance.
Division of Workforce Management.
Recruitment.
Human Capital Management.
Special Programs.
Division of Management Services.
Travel and Conference Management.
Committee Management and Planning.
Space and Facilities Management.
Division of Financial Management.
Budget Formulation.
Budget Execution.
Financial Accountability.
Office of Policy.
Guidance, Legislation and Special Projects.
Regulatory Documents and Special Projects.
Office of Product Evaluation and Quality.
Quality and Analytics Staff.
Clinical and Scientific Policy Staff.
Strategic Initiatives Staff.
Regulation, Policy and Guidance Staff.
Compliance and Quality Staff.
Operations Staff.
Office of Regulatory Programs.
Division of Regulatory Programs 1 (Division of Submission Support).
Division of Regulatory Programs 2 (Division of Establishment
Support).
Division of Regulatory Programs 3 (Division of Market
Intelligence).
Office of Clinical Evidence and Analysis.
Division of Clinical Evidence and Analysis 1 (Division of Clinical
Science and Quality).
Division of Clinical Evidence and Analysis 2 (Division of
Biostatistics).
Office of Health Technology 1 (OHT1: Office of Ophthalmic, Anesthesia,
Respiratory, ENT and Dental Devices).
Division of Health Technology 1A (Division of Ophthalmic Devices).
Division of Health Technology 1B (Division of Dental Devices).
Division of Health Technology 1C (Division of ENT, Sleep Disordered
Breathing, Respiratory and Anesthesia Devices).
Office of Health Technology 2 (OHT2: Office of Cardiovascular Devices).
Division of Health Technology 2A (Division of Cardiac
Electrophysiology, Diagnostics, and Monitoring Devices).
Division of Health Technology 2B (Division of Circulatory Support,
Structural and Vascular Devices).
Division of Health Technology 2C (Division of Coronary and
Peripheral Interventional Devices).
Office of Health Technology 3 (OHT3: Office of Gastrorenal, ObGyn,
General Hospital and Urology Devices).
Division of Health Technology 3A (Division of Renal,
Gastrointestinal, Obesity, and Transplant Devices).
Division of Health Technology 3B (Division of Reproductive,
Gynecology and Urology Devices).
Division of Health Technology 3C
[[Page 18441]]
(Division of Drug Delivery and General Hospital Devices, and Human
Factors).
Office of Health Technology 4 (OHT4: Office of Surgical and Infection
Control Devices).
Division of Health Technology 4A (Division of General Surgery
Devices).
Division of Health Technology 4B (Division of Infection Control and
Plastic Surgery Devices).
Office of Health Technology 5 (OHT5: Office of Neurological and
Physical Medicine Devices).
Division of Health Technology 5A (Division of Neurological,
Neurointerventional and Neurodiagnostic Devices).
Division of Health Technology 5B (Division of Neuromodulation and
Physical Medicine Devices).
Office of Health Technology 6 (OHT6: Office of Orthopedic Devices).
Division of Health Technology 6A (Division of Joint Arthroplasty
Devices).
Division of Health Technology 6B (Division of Spinal Devices).
Division of Health Technology 6C (Division of Stereotaxic, Trauma
and Restorative, Devices).
Office of Health Technology 7 (OHT7: Office of In Vitro Diagnostics and
Radiological Health).
Division of Program Operations and Management.
Division of Chemistry and Toxicology Devices.
Chemistry Branch.
Diabetes Branch.
Toxicology Branch.
Cardio-Renal Diagnostics Branch.
Division of Molecular Genetics and Pathology.
Molecular Pathology and Cytology Branch.
Molecular Genetics Branch.
Division of Immunology and Hematology Devices.
Hematology Branch.
Immunology and Flow-Cytometry Branch.
Division of Microbiology Devices.
Viral Respiratory and HPV Branch.
General Viral and Hepatitis Branch.
General Bacterial and Antimicrobial Susceptibility Branch.
Bacterial Respiratory and Medical Countermeasures Branch.
Division of Radiological Health.
Magnetic Resonance and Electronic Products Branch.
Diagnostic X-Ray Systems Branch.
Nuclear Medicine and Radiation Therapy Branch.
Mammography, Ultrasound and Imaging Software Branch.
Division of Mammography Quality Standards.
Office of Science and Engineering Laboratories.
Immediate Office of the Director
Division of Applied Mechanics.
Division of Biomedical Physics.
Division of Biology, Chemistry and Materials Science.
Division of Imaging, Diagnostics, and Software Reliability.
Division of Administrative and Laboratory Support.
Office of Strategic Partnerships and Technology Innovation.
Innovation.
Division of All Hazards Response Science and Strategic
Partnerships.
Medical Device Development Tools.
Health of Women.
Pediatrics and Special Populations.
All Hazards Readiness Response and Cybersecurity.
Patient Science and Engagement.
Partnerships to Advance Innovation and Regulatory Science.
Science and Special Projects Incubator.
Standards and Conformity Assessment Program.
Division of Digital Health.
Operational Excellence.
Technical and Policy Leadership Strategic Partnerships and
Initiatives 1.
Technical and Policy Leadership Strategic Partnerships and
Initiatives 2.
Strategic Initiatives and Special Projects.
Division of Technology and Data Services.
Business and Transformation Services.
Data Services.
Technology Services.
* * * * *
PART 801--LABELING
0
5. The authority citation for part 801 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 360d, 360i, 360j, 371,
374.
0
6. In Sec. 801.55, revise paragraph (b)(2) to read as follows:
Sec. 801.55 Request for an exception from or alternative to a unique
device identifier requirement.
* * * * *
(b) * * *
(2) In all other cases, by email to: [email protected], or
by correspondence to: UDI Regulatory Policy Support, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 3293, Silver Spring, MD 20993-0002.
* * * * *
0
7. In Sec. 801.57, revise paragraph (c)(2) to read as follows:
Sec. 801.57 Discontinuation of legacy FDA identification numbers
assigned to devices.
* * * * *
(c) * * *
(2) No later than September 24, 2014, the labeler submits, and
obtains FDA approval of, a request for continued use of the assigned
labeler code. A request for continued use of an assigned labeler code
must be submitted by email to: [email protected], or by
correspondence to: UDI Regulatory Policy Support, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 3293, Silver Spring, MD 20993-0002.
* * * * *
PART 803--MEDICAL DEVICE REPORTING
0
8. The authority citation for part 803 continues to read as follows:
Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.
0
9. In Sec. 803.11, revise 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 https://www.accessdata.fda.gov/scripts/medwatch/index.cfm.
0
10. In Sec. 803.19(b), revise the second sentence to read as follows:
Sec. 803.19 Are there exemptions, variances, or alternative forms of
adverse event reporting requirements?
* * * * *
(b) * * * You must submit the request to us in writing at the
following address: MDR Exemption Requests, Medical Device Report (MDR)
Team, Division of Regulatory Programs 3, Office of Regulatory Programs,
Office of Product Evaluation and Quality, 10903 New Hampshire Ave.,
Bldg. 66, Rm.1523, Silver Spring, MD 20993-0002. * * *
* * * * *
0
11. In Sec. 803.21, revise paragraph (a) to read as follows:
Sec. 803.21 Where can I find the reporting codes for adverse events
that I use with medical device reports?
(a) The MedWatch Medical Device Reporting Code Instruction Manual
contains adverse event codes for use with Form FDA 3500A. You may
obtain the coding manual from FDA's website
[[Page 18442]]
at: https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/mdr-adverse-event-codes.
* * * * *
0
12. In Sec. 803.33, revise paragraph (a) to read as follows:
Sec. 803.33 If I am a user facility, what must I include when I
submit an annual report?
(a) You must submit to us an annual report on Form FDA 3419. You
must submit an annual report by January 1, of each year. You may obtain
this form on the internet at: https://www.fda.gov/media/72292/download.
* * * * *
PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR
MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES
0
13. The authority citation for part 807 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 360, 360c, 360e, 360i,
360j, 360bbb-8b, 371, 374, 379k-1, 381, 393; 42 U.S.C. 264, 271.
0
14. In Sec. 807.21, revise paragraph (b) introductory text to read as
follows:
Sec. 807.21 How to register establishments and list devices.
* * * * *
(b) If the information under Sec. 807.21(a) cannot be submitted
electronically, a waiver may be requested. Waivers will be granted only
if use of electronic means is not reasonable for the person requesting
the waiver. To request a waiver, applicants must send a letter to the
Imports and Registration and Listing Team, Division of Regulatory
Programs 2, Office of Regulatory Programs, Office of Product Evaluation
and Quality, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.1432, Silver
Spring, MD 20993-0002, that includes the following information:
* * * * *
0
15. In Sec. 807.34, revise paragraph (a) to read as follows:
Sec. 807.34 Summary of requirements for owners or operators granted
a waiver from submitting required information electronically.
(a) For initial registration and listing, owners or operators who
have been granted a waiver from electronic filing using the procedures
set forth in Sec. 807.21(b) must send a letter containing all of the
registration and listing information described in Sec. Sec. 807.22,
807.25 (and Sec. 807.26 when such information is requested by FDA), at
the times described in Sec. 807.22, to: The Imports and Registration
and Listing Team, Division of Regulatory Programs 2, Office of
Regulatory Programs, Office of Product Evaluation and Quality, Center
for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 1432, Silver Spring, MD 20993-
0002.
* * * * *
0
16. In Sec. 807.37, revise paragraph (a) to read as follows:
Sec. 807.37 Public availability of establishment registration and
device listing information.
(a) Establishment registration and device listing information is
available for public inspection in accordance with section 510(f) of
the Federal Food, Drug, and Cosmetic Act and will be posted on the FDA
website, with the exception of the information identified in paragraph
(b) of this section. Requests for information by persons who do not
have access to the internet should be directed to the Imports and
Registration and Listing Team, Division of Regulatory Programs 2,
Office of Regulatory Programs, Office of Product Evaluation and
Quality, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.1432, Silver
Spring, MD 20993-0002. In addition, there will be available for
inspection at each of the Food and Drug Administration district offices
the same information for firms within the geographical area of such
district offices. Upon request, verification of a registration number
or location of a registered establishment will be provided.
* * * * *
PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES
0
17. The authority citation for part 814 continues to read as follows:
Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 360bbb-8b,
371, 372, 373, 374, 375, 379, 379e, 379k-1, 381.
0
18. In Sec. 814.42, revise paragraph (d)(2) to read as follows:
Sec. 814.42 Filing a PMA.
* * * * *
(d) * * *
(2) Request in writing within 10 working days of the date of
receipt of the notice refusing to file the PMA, an informal conference
with the Director of the associated Office of Health Technology to
review FDA's decision not to file the PMA. FDA will hold the informal
conference within 10 working days of its receipt of the request and
will render its decision on filing within 5 working days after the
informal conference. If, after the informal conference, FDA accepts the
PMA for filing, the date of filing will be the date of the decision to
accept the PMA for filing. If FDA does not reverse its decision not to
file the PMA, the applicant may request reconsideration of the decision
from the Director of the Office of Product Evaluation and Quality, the
Director of the Center for Biologics Evaluation and Research, or the
Director of the Center for Drug Evaluation and Research, as applicable.
The Director's decision will constitute final administrative action for
the purpose of judicial review.
* * * * *
0
19. In Sec. 814.100, revise paragraph (e)(2) to read as follows:
Sec. 814.100 Purpose and scope.
* * * * *
(e) * * *
(2) Submitting an HDE to the Office of Product Evaluation and
Quality (OPEQ), Center for Devices and Radiological Health (CDRH), the
Center for Biologics Evaluation and Research (CBER), or the Center for
Drug Evaluation and Research (CDER), as applicable.
* * * * *
PART 820--QUALITY SYSTEM REGULATION
0
20. The authority citation for part 820 continues to read as follows:
Authority: 21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h,
360i, 360j, 360l, 371, 374, 381, 383; 42 U.S.C. 216, 262, 263a, 264.
0
21. In Sec. 820.1, revise paragraph (e)(1) to read as follows:
Sec. 820.1 Scope.
* * * * *
(e) * * * (1) Any person who wishes to petition for an exemption or
variance from any device quality system requirement is subject to the
requirements of section 520(f)(2) of the Federal Food, Drug, and
Cosmetic Act. Petitions for an exemption or variance shall be submitted
according to the procedures set forth in Sec. 10.30 of this chapter,
the FDA's administrative procedures. For guidance on how to proceed for
a request for a variance, contact Division of Regulatory Programs 2,
Office of Regulatory Programs, Office of Product Evaluation and
Quality, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1438, Silver
Spring, MD 20993-0002.
* * * * *
[[Page 18443]]
PART 821--MEDICAL DEVICE TRACKING REQUIREMENTS
0
22. The authority citation for part 821 continues to read as follows:
Authority: 21 U.S.C. 331, 351, 352, 360, 360e, 360h, 360i, 371,
374.
0
23. In Sec. 821.2, revise paragraph (b) introductory text to read as
follows:
Sec. 821.2 Exemptions and variances.
* * * * *
(b) A request for an exemption or variance shall be submitted in
the form of a petition under Sec. 10.30 of this chapter and shall
comply with the requirements set out therein, except that a response
shall be issued in 90 days. The Director or Deputy Directors, CDRH, or
the Director of the Office of Regulatory Program, CDRH, shall issue
responses to requests under this section. The petition shall also
contain the following:
* * * * *
PART 822--POSTMARKET SURVEILLANCE
0
24. The authority citation for part 822 continues to read as follows:
Authority: 21 U.S.C. 331, 352, 360i, 360l, 371, 374.
0
25. In Sec. 822.7, revise paragraph (a)(1) to read as follows:
Sec. 822.7 What should I do if I do not agree that postmarket
surveillance is appropriate?
(a) * * *
(1) Requesting a meeting with the individual who issued the order
for postmarket surveillance;
* * * * *
0
26. In Sec. 822.22, revise paragraph (a)(1) to read as follows:
Sec. 822.22 What recourse do I have if I do not agree with your
decision?
(a) * * *
(1) Requesting a meeting with the individual who issued the order
for postmarket surveillance;
* * * * *
PART 830--UNIQUE DEVICE IDENTIFICATION
0
27. The authority citation for part 830 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 352, 353, 360, 360d, 360i, 360j,
371.
* * * * *
0
28. In Sec. 830.110, revise paragraph (a)(1) to read as follows:
Sec. 830.110 Application for accreditation as an issuing agency.
(a) * * *(1) An applicant seeking initial FDA accreditation as an
issuing agency shall notify FDA of its desire to be accredited by
sending a notification by email to: [email protected], or by
correspondence to: UDI Regulatory Policy Support, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 3293, Silver Spring, MD 20993-0002.
* * * * *
0
29. In Sec. 830.320, revise paragraphs (c)(1) and (3) to read as
follows:
Sec. 830.320 Submission of unique device identification information.
* * * * *
(c) * * * (1) A labeler may request a waiver from electronic
submission of UDI data by submitting a letter addressed to the
appropriate Center Director explaining why electronic submission is not
technologically feasible; send the request by email to:
[email protected], or by correspondence to: UDI Regulatory Policy
Support, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3293, Silver
Spring, MD 20993-0002.
* * * * *
(3) A labeler that has a waiver from electronic submission of UDI
data must send a letter containing all of the information required by
Sec. 830.310, as well as any ancillary information permitted to be
submitted under Sec. 830.340 that the labeler wishes to submit, within
the time permitted by Sec. 830.330, addressed to: UDI Regulatory
Policy Support, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3293,
Silver Spring, MD 20993-0002.
PART 860--MEDICAL DEVICE CLASSIFICATION PROCEDURES
0
30. The authority citation for part 860 continues to read as follows:
Authority: 21 U.S.C. 360c, 360d, 360e, 360i, 360j, 371, 374.
0
31. In Sec. 860.123, revise paragraph (b)(1) to read as follows:
Sec. 860.123 Reclassification petition: Content and form.
* * * * *
(b) * * *
(1) For devices regulated by the Center for Devices and
Radiological Health, addressed to the Food and Drug Administration,
Center for Devices and Radiological Health, Office of Policy Staff,
10903 New Hampshire Ave., Bldg. 66, Rm. 5445, Silver Spring, MD 20993-
0002; for devices regulated by the Center for Biologics Evaluation and
Research, addressed to the Food and Drug Administration, Center for
Biologics Evaluation and Research, Document Control Center, 10903 New
Hampshire Ave., Bldg. 71, Rm. G112, Silver Spring, MD 20993-0002; for
devices regulated by the Center for Drug Evaluation and Research,
addressed to the Food and Drug Administration, Center for Drug
Evaluation and Research, Central Document Control Room, 5901-B
Ammendale Rd., Beltsville, MD 20705-1266, as applicable.
* * * * *
PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES
0
32. The authority citation for part 884 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
33. In Sec. 884.5360, remove and reserve paragraph (c).
PART 900--MAMMOGRAPHY
0
34. The authority citation for part 900 continues to read as follows:
Authority: 21 U.S.C. 360i, 360nn, 374(e); 42 U.S.C. 263b.
0
35. In Sec. 900.3, revise paragraph (b)(1) to read as follows:
Sec. 900.3 Application for approval as an accreditation body.
* * * * *
(b) * * *(1) An applicant seeking initial FDA approval as an
accreditation body shall inform the Division of Mammography Quality
Standards, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3621, Silver
Spring, MD 20993, Attn: Program Management Branch, of its desire to be
approved as an accreditation body and of its requested scope of
authority.
* * * * *
0
36. In Sec. 900.15, revise paragraph (d)(3)(i) to read as follows:
Sec. 900.15 Appeals of adverse accreditation or reaccreditation
decisions that preclude certification or recertification.
* * * * *
(d) * * *
(3) * * *
(i) A facility must request reconsideration by DMQS within 60 days
of the accreditation body's adverse
[[Page 18444]]
appeals decision, at the following address: Food and Drug
Administration, Center for Devices and Radiological Health, Division of
Mammography Quality Standards, Attn: Facility Accreditation Review
Committee, 10903 New Hampshire Ave., Bldg. 66, Rm. 3621, Silver Spring,
MD 20993-0002.
* * * * *
0
37. In Sec. 900.18, revise paragraph (c) introductory text to read as
follows:
Sec. 900.18 Alternative requirements for Sec. 900.12 quality
standards.
* * * * *
(c) Applications for approval of an alternative standard. An
application for approval of an alternative standard or for an amendment
or extension of the alternative standard shall be submitted in an
original and two copies to the Food and Drug Administration, Center for
Devices and Radiological Health, Director, Division of Mammography
Quality Standards, 10903 New Hampshire Ave., Bldg. 66, Rm. 3621, Silver
Spring, MD 20993-0002. The application for approval of an alternative
standard shall include the following information:
* * * * *
0
38. In Sec. 900.21, revise paragraph (b)(1) to read as follows:
Sec. 900.21 Application for approval as a certification agency.
* * * * *
(b) * * * (1) An applicant seeking FDA approval as a certification
agency shall inform the Food and Drug Administration, Center for
Devices and Radiological Health, Director, Division of Mammography
Quality Standards, Attn: Program Management Branch, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3621, Silver Spring, MD 20993-0002, in writing, of
its desire to be approved as a certification agency.
* * * * *
PART 1002--RECORDS AND REPORTS
0
39. The authority citation for part 1002 continues to read as follows:
Authority: 21 U.S.C. 352, 360, 360i, 360j, 360hh-360ss, 371,
374.
0
40. In Sec. 1002.50, revise paragraph (c)(3) to read as follows:
Sec. 1002.50 Special exemptions.
* * * * *
(c) * * *
(3) Such conditions as are deemed necessary to protect the public
health and safety. Copies of exemptions shall be available upon request
from the Food and Drug Administration, Center for Devices and
Radiological Health, Division of Mammography Quality Standards, 10903
New Hampshire Ave., Bldg. 66, Rm. 3621, Silver Spring, MD 20993-0002.
* * * * *
Dated: March 23, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-06354 Filed 4-1-20; 8:45 am]
BILLING CODE 4164-01-P