81 FR 51201 - Medical X-Ray Imaging Devices Conformance With International Electrotechnical Commission Standards; Draft Guidance for Industry and Food and Drug Administration Staff; Availability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 149 (August 3, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 149 (August 3, 2016)
| Page Range | 51201-51204 | |
| FR Document | 2016-18300 |
[Federal Register Volume 81, Number 149 (Wednesday, August 3, 2016)] [Notices] [Pages 51201-51204] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-18300] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-2049] Medical X-Ray Imaging Devices Conformance With International Electrotechnical Commission Standards; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Medical X-Ray Imaging Devices Conformance With IEC Standards.'' This draft guidance describes FDA's policy regarding the regulation of medical x-ray imaging equipment that are subject to requirements in the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and FDA's regulations that apply to medical devices and electronic products. The draft guidance also provides recommendations to industry on how to comply with the applicable requirements. This draft guidance is not final nor is it in effect at this time.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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by November 1, 2016.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. [[Page 51202]] 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: 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-2016-D-2049 for ``Medical X-Ray Imaging Devices Conformance With IEC Standards.'' 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 ``Medical X-Ray Imaging Devices Conformance With IEC Standards'' 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. Send one self-addressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: Robert Sauer, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5628, Silver Spring, MD 20993-0002, 301-796-3580. SUPPLEMENTARY INFORMATION: I. Background This draft guidance describes FDA's policy regarding the regulation of medical x-ray imaging equipment that are subject to requirements in the FD&C Act and FDA's regulations that apply to medical devices and electronic products. In the draft guidance, FDA is seeking to harmonize performance standards prescribed under section 534 of subchapter C (Electronic Product Radiation Control (EPRC)) of the FD&C Act (21 U.S.C. 360kk) with International Electrotechnical Commission (IEC) standards, where appropriate, to help to ensure streamlined regulatory review of submissions for these products. The draft guidance also provides recommendations to industry on how to comply with the applicable requirements. FDA believes industry conformance to certain IEC standards would provide the same level of or improved protection of the public health and safety from electronic radiation as certain EPRC regulatory standards. FDA also believes conformance to certain IEC standards would be sufficient to meet the 510(k) premarket notification requirement for certain devices. FDA review of related radiological health and safety data in premarket submissions, as opposed to EPRC product reports, would maintain or improve device safety while consolidating the information manufacturers submit to FDA. 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 ``Medical X- Ray Imaging Devices Conformance With IEC Standards.'' 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 CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at http://www.regulations.gov. Persons unable to download an electronic copy of ``Medical X-Ray Imaging Devices Conformance With IEC Standards'' may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1400014 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501- 3520), Federal Agencies must obtain approval [[Page 51203]] from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed revision of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Reporting and Recordkeeping for Electronic Products--General Requirements--21 CFR parts 1002 through 1050--OMB Control Number 0910- 0025--Revision The draft guidance describes FDA's policy regarding the regulation of medical x-ray imaging equipment that are subject to FDA's regulations that apply to medical devices and electronic products. FDA believes industry conformance to certain IEC standards would be sufficient to meet the 510(k) premarket notification requirement for certain of these devices. FDA review of related radiological health and safety data in premarket submissions, as opposed to EPRC product reports, would maintain or improve device safety while consolidating the information manufacturers submit to FDA. Currently, information regarding the IEC standards is submitted as part of the premarket notification (approved under OMB control number 0910-0120). Under the draft guidance, if finalized, respondents may choose to submit declarations of conformity with certain IEC standards--in either a 510(k) or if no 510(k) is submitted in an Abbreviated Report under 21 CFR 1002.12(e)--instead of submitting EPRC reports for certain devices in the circumstances described in the draft guidance. Based on an analysis of recent submissions from Fiscal Year (FY) 2015, approximately 93 percent of manufacturers of Class II medical x- ray imaging devices, including CT, fluoroscopy, and stationary x-ray systems, claimed conformance to an applicable IEC standard. Accordingly, we believe that the majority of manufacturers of Class II medical x-ray imaging systems would choose to continue to submit declarations of conformity to these IEC standards and not submit EPRC product reports, supplemental reports, and annual reports under the guidance. The other 7 percent of manufacturers of Class II medical x- ray imaging devices and likely a subset of these 93 percent may choose to submit product reports, supplemental reports, and annual reports. In FY 2015, there were 22 Class II product reports and 13 Class I product reports for x-ray imaging devices submitted to FDA. Therefore, we expect a reduction of 34 respondents to the estimated burden for the product reports, supplemental reports, and annual report information collections in table 1 of this document. Because 13 of these x-ray imaging devices are 510(k)-exempt, Class I devices, we would expect an increase of 13 respondents to the estimated burden for the information collection related to Abbreviated Reports in table 1 of this document (as these manufacturers would be submitting their declarations of conformity in these reports), which corresponds to an expected reduction of 13 respondents to the estimated burden for the product reports, supplemental reports, and annual reports information collections in table 1 of this document. This equals an overall reduction of 1,395 hours in OMB control number 0910-0025. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1,2,3\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Average Activity/21 CFR section FDA form Number of responses per Total annual burden per Total hours respondents respondent responses response -------------------------------------------------------------------------------------------------------------------------------------------------------- Product reports--1002.10(a)-(k)........ 3626--Diagnostic x-ray......... 1,466 1.1 1,613 24 38,712 3627--CT x-ray................. 3639--Cabinet x-ray............ 3632--Laser.................... .............. 3640--Laser light show......... .............. 3630--Sunlamp.................. .............. 3646--Mercury vapor lamp....... .............. 3644--Ultrasonic therapy....... .............. 3659--TV....................... .............. 3660--Microwave oven........... .............. 3801--UV lamps................. .............. Product safety or testing changes-- ............................... 966 1.5 1,449 0.5 725 1002.11(a)-(b). Abbreviated reports--1002.12........... 3629--General abbreviated 73 2 146 5 730 report. 3661--X-ray tables, etc........ 3662--Cephalometric device..... .............. 3663--Microwave products (non- .............. oven). [[Page 51204]] Annual reports--1002.13(a)-(b)......... 3628--General.................. 1,466 1 1,466 18 26,388 3634--TV....................... 3638--Diagnostic x-ray......... 3641--Cabinet x-ray............ .............. 3643--Microwave oven........... .............. 3636--Laser.................... .............. 3631--Sunlamp.................. .............. 3647--Mercury vapor lamp....... .............. 3645--Ultrasonic therapy....... .............. -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ This table includes the recalculated burden estimate only for information collections (ICs) that are applicable to this draft guidance. It does not include all ICs approved under OMB control number 0910-0025. The draft guidance, if finalized, would be a reduction to the burden estimate for these ICs, except that the Abbreviated reports IC increases. We have described the overall reduction in the text of this document. However, to avoid confusion, we have not included a total burden estimate in this table because such a total would include ICs that are not applicable to the draft guidance. \2\ There are no capital costs or operating and maintenance costs associated with this collection of information. \3\ Totals may not sum due to rounding. The draft guidance also refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR part 807, subpart E have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 801 have been approved under OMB control number 0910-0485; the collections of information in 21 CFR part 820 have been approved under OMB control number 0910-0073. The collections of information in 21 CFR parts 1002 through 1050 are approved under OMB control number 0910- 0025. Dated: July 28, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-18300 Filed 8-2-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 149 / Wednesday, August 3, 2016 / Notices 51201
that half of the control practices (25/50) the participating current and past of CAHPS patient experience data files.
administer CG–CAHPS data, as this CAHPS practices (90/100) will submit As indicated below, the annual total
percentage is unknown; while 90% of CAHPS data, yielding 115 submissions burden is estimated to be 179 hours.
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of Hours per Total burden
Data collection task Number of respondents responses per response hours
respondent
Office Manager Questions ......................................... 150 ................................... 1 ......................................... 5/60 12.5
Physician Interview .................................................... 150 ................................... 1 ......................................... 40/60 100
PCMH–A Assessment Tool ....................................... 150 (same physicians as 1 (same person as above) 15/60 37.5
above).
CAHPS Patient Experience Data Files ..................... 115 ................................... 1 per practice ..................... 15/60 28.75
Total .................................................................... 415 ................................... 1 ......................................... 75/60 178.75
+ The same respondent completes the Physician Interview and PCMH–A Assessment Tool and submits the CAHPS Patient Experience Data
Files.
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Average
Number of Total burden Total cost
Data collection task hourly wage
requests hours burden
rate *
Office Manager Questions ............................................................................... 150 12.5 a $57.44 $718.00
Physician Interview .......................................................................................... 150 100 b 97.33 9,733.00
PCMH–A Assessment Tool ............................................................................. 150 37.5 b 97.33 3,649.88
CAHPS Patient Experience Data Files ............................................................ 115 28.75 b 97.33 2,798.24
Total .......................................................................................................... 300 178.75 55.48 16,899.12
+ The same respondent completes the Physician Interview and PCMH–A Assessment Tool and submits the CAHPS Patient Experience Data
Files.
* Occupational Employment Statistics, May 2015 National Occupational Employment and Wage Estimates United States, U.S. Department of
Labor, Bureau of Labor Statistics. http://www.bls.gov/oes/current/oes_nat.htm.
a Based on the mean wages for General and Operations Managers, 11–1021 within Healthcare Support Occupations, the occupational group
most likely tasked with completing the Office Manager Questions.
b Based on the mean wages for Physicians and Surgeons, 29–1060, the occupational group most likely tasked with completing the Physician
Interview, PCMH–A Assessment Tool, and submitting the CAHPS Patient Experience Data Files.
Request for Comments comments will become a matter of describes FDA’s policy regarding the
public record. regulation of medical x-ray imaging
In accordance with the Paperwork equipment that are subject to
Reduction Act, comments on AHRQ’s Sharon B. Arnold,
requirements in the Federal Food, Drug,
information collection are requested Deputy Director.
and Cosmetic Act (the FD&C Act) and
with regard to any of the following: (a) [FR Doc. 2016–18392 Filed 8–2–16; 8:45 am] FDA’s regulations that apply to medical
Whether the proposed collection of BILLING CODE 4160–90–P devices and electronic products. The
information is necessary for the proper draft guidance also provides
performance of AHRQ health care recommendations to industry on how to
research and health care information DEPARTMENT OF HEALTH AND comply with the applicable
HUMAN SERVICES requirements. This draft guidance is not
dissemination functions, including
whether the information will have Food and Drug Administration final nor is it in effect at this time.
practical utility; (b) the accuracy of DATES: Although you can comment on
AHRQ’s estimate of burden (including [Docket No. FDA–2016–D–2049]
any guidance at any time (see 21 CFR
hours and costs) of the proposed Medical X-Ray Imaging Devices 10.115(g)(5)), to ensure that the Agency
collection(s) of information; (c) ways to Conformance With International considers your comment on this draft
enhance the quality, utility, and clarity Electrotechnical Commission guidance before it begins work on the
of the information to be collected; and Standards; Draft Guidance for Industry final version of the guidance, submit
(d) ways to minimize the burden of the and Food and Drug Administration either electronic or written comments
collection of information upon the Staff; Availability on the draft guidance by November 1,
respondents, including the use of 2016.
automated collection techniques or AGENCY: Food and Drug Administration,
ADDRESSES: You may submit comments
asabaliauskas on DSK3SPTVN1PROD with NOTICES
other forms of information technology. HHS.
ACTION: Notice of availability. as follows:
Comments submitted in response to
Electronic Submissions
this notice will be summarized and SUMMARY: The Food and Drug
included in the Agency’s subsequent Administration (FDA or Agency) is Submit electronic comments in the
request for OMB approval of the announcing the availability of the draft following way:
proposed information collection. All guidance entitled ‘‘Medical X-Ray • Federal eRulemaking Portal: http://
Imaging Devices Conformance With IEC www.regulations.gov. Follow the
Standards.’’ This draft guidance instructions for submitting comments.
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![51204 Federal Register / Vol. 81, No. 149 / Wednesday, August 3, 2016 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1,2,3—Continued
Number of Average
Activity/21 CFR Number of Total annual
FDA form responses per burden per Total hours
section respondents responses
respondent response
Annual reports— 3628—General .................................. 1,466 1 1,466 18 26,388
1002.13(a)–(b). 3634—TV ...........................................
3638—Diagnostic x-ray .....................
3641—Cabinet x-ray ..........................
3643—Microwave oven .....................
3636—Laser ......................................
3631—Sunlamp .................................
3647—Mercury vapor lamp ...............
3645—Ultrasonic therapy ..................
1 This table includes the recalculated burden estimate only for information collections (ICs) that are applicable to this draft guidance. It does not
include all ICs approved under OMB control number 0910–0025. The draft guidance, if finalized, would be a reduction to the burden estimate for
these ICs, except that the Abbreviated reports IC increases. We have described the overall reduction in the text of this document. However, to
avoid confusion, we have not included a total burden estimate in this table because such a total would include ICs that are not applicable to the
draft guidance.
2 There are no capital costs or operating and maintenance costs associated with this collection of information.
3 Totals may not sum due to rounding.
The draft guidance also refers to (OMB) for review and clearance under sterilization at another establishment, a
previously approved collections of the Paperwork Reduction Act of 1995. practice that facilitates the processing of
information found in FDA regulations. DATES: Fax written comments on the devices and is economically necessary
These collections of information are collection of information by September for some firms.
subject to review by OMB under the 2, 2016. Under § 801.150(e)(1), manufacturers
PRA. The collections of information in ADDRESSES: To ensure that comments on
and sterilizers may sign an agreement
21 CFR part 807, subpart E have been the information collection are received, containing the following: (1)
approved under OMB control number OMB recommends that written Instructions for maintaining
0910–0120; the collections of accountability of the number of units in
comments be faxed to the Office of
information in 21 CFR part 801 have each shipment, (2) acknowledgment that
Information and Regulatory Affairs,
been approved under OMB control the devices that are nonsterile are being
OMB, Attn: FDA Desk Officer, FAX:
number 0910–0485; the collections of shipped for further processing, and (3)
202–395–7285, or emailed to oira_
information in 21 CFR part 820 have specifications for sterilization
submission@omb.eop.gov. All
been approved under OMB control processing. This agreement allows the
comments should be identified with the
number 0910–0073. The collections of manufacturer to ship misbranded
OMB control number 0910–0131. Also
information in 21 CFR parts 1002 products to be sterilized without
include the FDA docket number found
through 1050 are approved under OMB initiating regulatory action and provides
in brackets in the heading of this
control number 0910–0025. FDA with a means to protect consumers
document. from use of nonsterile products. During
Dated: July 28, 2016. FOR FURTHER INFORMATION CONTACT: FDA routine plant inspections, FDA normally
Leslie Kux, PRA Staff, Office of Operations, Food reviews agreements that must be kept
Associate Commissioner for Policy. and Drug Administration, Three White for 2 years after final shipment or
[FR Doc. 2016–18300 Filed 8–2–16; 8:45 am] Flint North 10A–12M, 11601 delivery of devices (§ 801.150(a)(2)).
BILLING CODE 4164–01–P Landsdown St., North Bethesda, MD The respondents to this collection of
20852, PRAStaff@fda.hhs.gov. information are device manufacturers
SUPPLEMENTARY INFORMATION: In and contract sterilizers. FDA’s estimate
DEPARTMENT OF HEALTH AND compliance with 44 U.S.C. 3507, FDA of the reporting burden is based on data
HUMAN SERVICES has submitted the following proposed obtained from industry over the past
collection of information to OMB for several years. It is estimated that each of
Food and Drug Administration the firms subject to this requirement
review and clearance.
prepares an average of 20 written
[Docket No. FDA–2013–N–0375] Agreement for Shipment of Devices for agreements each year. This estimate
Sterilization—21 CFR 801.150—OMB varies greatly, from 1 to 100, because
Agency Information Collection Control Number 0910–0131—Extension some firms provide sterilization services
Activities; Submission for Office of
Under sections 501(c) and 502(a) of on a part-time basis for only one
Management and Budget Review;
the Federal Food, Drug, and Cosmetic customer, while others are large
Comment Request; Agreement for
Act (the FD&C Act) (21 U.S.C. 351(c) facilities with many customers. The
Shipment of Devices for Sterilization
and 352(a)), nonsterile devices that are average time required to prepare each
Food and Drug Administration, labeled as sterile but are in interstate written agreement is estimated to be 4
asabaliauskas on DSK3SPTVN1PROD with NOTICES
AGENCY:
HHS. transit to a facility to be sterilized are hours. This estimate varies depending
ACTION: Notice. adulterated and misbranded. FDA on whether the agreement is the initial
regulations in § 801.150(e) (21 CFR agreement or an annual renewal, on the
SUMMARY: The Food and Drug 801.150(e)) establish a control format each firm elects to use, and on
Administration (FDA) is announcing mechanism by which firms may the length of time required to reach
that a proposed collection of manufacture and label medical devices agreement. The estimate applies only to
information has been submitted to the as sterile at one establishment and ship those portions of the written agreement
Office of Management and Budget the devices in interstate commerce for that pertain to the requirements
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Document Created: 2016-08-02 23:43:55
Document Modified: 2016-08-02 23:43:55
| 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 on 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 1, 2016. | |
| Contact | Robert Sauer, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5628, Silver Spring, MD 20993-0002, 301-796-3580. | |
| FR Citation | 81 FR 51201 |
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