The U.S. Treasury Department has recently expanded the range of medical devices that may be exported or reexported from the United States to Iran without the need for specific authorization from the department’s Office of Foreign Assets ... Read More
Pemco Inc. received a Form 483 when inspectors found it had not submitted timely correction and removal and MDR reports, and had committed other violations. Read More
The FDA has compiled 22 case studies — including for two medical devices — that showed promise in Phase II clinical trials but later failed in larger Phase III trials. Read More
Malaysia’s Medical Device Authority has issued new guidance to manufacturers on regulatory requirements for making changes to registered medical devices. Read More
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