Differences in US FDA Medical Device Classifications
In the United States, the Food and Drug Administration’s (FDA) Center for Devic [...]
FDA PMTA Marketing Granted Orders: Full List (Updated 10/19/2021)
MARKETING GRANTED ORDERS SOURCE: FDA Denial Orders: 7 Last Update: 10/19/2021 [...]
FDA PMTA Warning Letters and Denial Orders: Full List (Updated 09/09/2021)
WARNING LETTERS SOURCE: FDA Total Warning Letters to Date: 168 Last Update: 0 [...]
FDA PMTA Denial Orders: Full List (Updated 11/03/2021)
DENIAL ORDERS SOURCE: FDA Denial Orders: 260 Last Update: 11/03/2021 **Note: [...]
FDA PMTA Warning Letter Closeouts: Full List (Updated 09/09/2021)
WARNING LETTER CLOSEOUTS SOURCE: FDA FDA Warning Letter - Closeouts: 7 Last U [...]
FDA PMTA Warning Letters: Full List (Updated 11/12/2021)
WARNING LETTERS SOURCE: FDA Total Warning Letters to Date: 226 Last Update: 1 [...]
What FDA’s Recent PMTA Denials Mean for the E-Cigarette Industry
Background With the FDA’s deadline of September 9, 2021 to finalize the review [...]
FDA PMTA Warning Letters and Denial Orders: Full List (Updated 09/09/2021)
WARNING LETTERS SOURCE: FDA Total Warning Letters to Date: 168 Last Update: 0 [...]
FDA PMTA Warning Letters and Denial Orders: Full List (Updated 09/08/2021)
WARNING LETTERS SOURCE: FDA Total Warning Letters to Date: 162 Last Update: 0 [...]
FDA PMTA Warning Letters: Full List (Updated 08/02/2021)
SOURCE: FDA Total Warning Letters to Date: 133 Last Update: 08/02/2021 Search b [...]