Tuesday, January 10, 2017

News: FDA released draft guidance on Premarket Notification (510(k)) Submissions for Bone AnchorsFDA released draft guidance on Premarket Notification (510(k)) Submissions for Bone Anchors

Federal eRulemaking Portal: https://www.regulations.gov.

Image result for FDAFollow 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'').

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