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Proposed Rules › 510(k) RTA › Food and Drug Administration (FDA)

King & Spalding

FDA Issues Proposed Rule Classifying Certain Wound Dressings and Liquid Wound Washes For the First Time

King & Spalding on

After enactment of the Medical Device Amendments of 1976, which established three regulatory classes for medical devices, the Food and Drug Administration (FDA) has been required to classify all medical devices into Class I,...more

Mintz - Health Care Viewpoints

Regulatory Roundup: Important FDA Developments at the End of September 2022

Mintz - Health Care Viewpoints on

There were so many interesting and significant developments related to the various missions of the U.S. Food and Drug Administration (FDA) during the last week or so of September 2022 that we decided to create a summary...more

BakerHostetler

BakerHostetler FDA and Pharmacy Weekly Digest - February 2019 #4

BakerHostetler on

Food/Dietary Supplements - FDA Notes Increased Concerns About Use of Kratom – As the number of reports of poisonings related to the use of kratom increases, Commissioner Gottlieb tweeted, “Kratom is an opioid. #FDA...more

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