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Searching Content indexed under Food, Drugs, Healthcare, Life Sciences by Jennifer Agraz Henderson ordered by Published Date Descending.
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Clarifying Clinical Decision Support: FDA Overhauls Guidance To Focus On Risk
On 27 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released the draft guidance entitled "Clinical Decision Support Software" (CDS guidance), ...
United States
11 Oct 2019
2
FDA Issues Draft Guidance On Providing Regulatory Submissions In Electronic Format
On 26 September 2019 the U.S. Food and Drug Administration (FDA or the agency) published a draft guidance document entitled "Providing Regulatory Submissions for Medical Devices
United States
4 Oct 2019
3
FDA Announces New Expedited Program For Devices Expected To Significantly Improve The Safety Of Existing Technologies
On 19 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released the draft guidance document entitled "Safer Technologies Program for Medical Devices"
United States
30 Sep 2019
4
FDA Releases Four Final Guidances On The 510(k) Program; Special 510(k) Guidance Confirms New Approach To Eligibility And Broader Potential For IVDs
On 13 September 2019 the U.S. Food and Drug Administration (FDA or the agency) published four final guidance documents on the 510(k) program:
United States
24 Sep 2019
5
Final Guidance Provides Additional Clarity To The Humanitarian Device Exemption Program
On 6 September 2019 the U.S. Food and Drug Administration (FDA or the agency) issued its final guidance document entitled "Humanitarian Device Exemption (HDE) Program."
United States
12 Sep 2019
6
De Novo Requests: FDA Releases Updated RTA Checklist
On 9 September 2019 the U.S. Food and Drug Administration (FDA or the agency) issued its final guidance document entitled "Acceptance Review for De Novo Classification Requests.
United States
11 Sep 2019
7
CDRH Issues Final Rule On Appeals, Excluding De Novos From 517A
On 2 July 2019 the U.S. Food and Drug Administration (FDA or the agency) issued a final rule1 updating the processes for appeal of certain FDA decisions related to medical devices regulated
United States
18 Jul 2019
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