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                Guidance Documents (Medical Devices and Radiation-Emitting Products)

Guidance Documents (Medical Devices and Radiation-Emitting Products)

                        Cross-Center Final Guidance
          Recent Final Medical Device Guidance Documents
          Draft Medical Device Guidance
          CDRH Proposed Guidance Development
          Class II Special Controls Documents
          Withdrawn or Expired Guidance
          Tips for Submitting Comments on CDRH Guidance Documents Home
          Medical Devices
          Device Advice: Comprehensive Regulatory Assistance
          Guidance Documents (Medical Devices and Radiation-Emitting Products)
          Tips for Submitting Comments on CDRH Guidance DocumentsGuidance Documents (Medical Devices and Radiation-Emitting Products) Tips for Submitting Comments on CDRH Guidance Documents
  
  	
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    PrintPublic comments on the FDA's Center for Devices and Radiological Health (CDRH) guidance documents are critical to the guidance development process and help us ensure our recommendations meet stakeholder needs. In accordance with 21 CFR 10.115, the FDA considers comments received and revises guidances, as appropriate. Below are some tips and recommendations, as well as some instructions on how to submit comments for a guidance.

Tips

Submit either electronic or written comments on the guidance by the comment close date listed on the CDRH guidance web page and associated Federal Register Notice announcing the draft guidance to ensure that FDA considers your comments on the draft guidance before it begins work on the final version of the guidance.

	You can comment on any guidance document at any time (21 CFR 10.115(g)(5)), including final guidance documents. However, comments may not be acted upon by the Agency until the document is next revised or updated.
	Be concise and clear; proposing revised or additional language is also appreciated (if practical).
	Include a reference to the section(s) of the guidance the comment is intended to address; inclusion of line numbers is preferred.
	Include an explanation to ensure that CDRH is able to understand and better assess the comment.
	Avoid repeating the same comment multiple times within a comment response for the same guidance; if a comment or proposed edit applies to several different sections of the guidance, identify the first instance, and note that the recommendation applies to other line numbers (if practical), sections, and/or throughout the guidance.
	Comments provided in a table format typically facilitates CDRH's analysis and compilation of comments received; this can be provided as a document or spreadsheet; see the example below:Line Number(s) or Section
			Comment (include an explanation)
			Proposed New or Edited Language (if applicable)Note: Avoid submitting multiple comments in paragraph form. Such format can cause difficulty in clearly identifying and distinguishing between each comment so that CDRH can adequately assess them.

How to submit comments to the docket

Electronic submissions:

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

Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
	For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in "Instructions."**Docket**

All submissions received must include the Docket No. listed on the CDRH guidance web page and guidance title. For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found on the CDRH guidance web page, into the "Search" box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

Received comments will be placed in the docket and, except for those submitted as "Confidential Submissions," publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff.

If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as "confidential." Any information marked as "confidential" will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law.

For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

                                                                                  Content current as of:
      08/16/2023
              
              
Regulated Product(s)
		 Medical Devices
			  			     			  			     Radiation-Emitting ProductsGuidance Documents (Medical Devices and Radiation-Emitting Products)

          
                        Cross-Center Final Guidance
          Recent Final Medical Device Guidance Documents
          Draft Medical Device Guidance
          CDRH Proposed Guidance Development
          Class II Special Controls Documents
          Withdrawn or Expired Guidance
          Tips for Submitting Comments on CDRH Guidance Documents
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