Department of Health and Human Services January 13, 2020 – Federal Register Recent Federal Regulation Documents
Results 1 - 9 of 9
Meeting of the Advisory Committee on Minority Health
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (HHS or Department) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting will be open to the public. Preregistration by January 24, 2020, is required for the public to attend the meeting, provide comments, and/or distribute printed material(s) to ACMH members. Information about the meeting is available from the designated contact person and will be posted on the website for the Office of Minority Health (OMH), www.minorityhealth.hhs.gov. Information about ACMH activities can be found on the OMH website under the heading About OMH.
Peripheral Percutaneous Transluminal Angioplasty and Specialty Catheters-Premarket Notification (510(k)) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters Premarket Notification (510(k)) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff.'' The FDA is issuing this draft guidance document to provide recommendations for 510(k) submissions for peripheral percutaneous transluminal angioplasty (PTA) balloons and specialty catheters (e.g., infusion catheters, PTA balloon catheters for in-stent restenosis (ISR), scoring/cutting balloons). This draft guidance is not final nor is it in effect at this time.
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