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2 Total results for product and free and sample content found

Pink Sheet

AdvaMed Floats Legislation To Allow User-Fee Submissions During Shutdowns

By Ferdous Al-Faruque 15 Jun 2019

AdvaMed Floats Legislation To Allow User-Fee Submissions During Shutdowns

As the partial US government shutdown enters its second month, the backlog of device pre-market applications is building. AdvaMed is proposing language that would allow FDA to accept and review new user-fee-funded submissions during government shutdowns.

Topic US Shutdown FDA

Medtech Insight

Bumps In The Road As US FDA Tries To Catch Up From Shutdown

11 Jun 2019

Bumps In The Road As US FDA Tries To Catch Up From Shutdown

The recently ended record-setting US government shutdown is not anticipated to have a long-term impact on US FDA device review times. But agency reviewers will face more 510(k) review deadline pressures than usual and may have limited availability for pre-submission meetings in the short term, one expert suggests.

Topic FDA US Shutdown

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