Image result for CDRH guidances

 

WHAT: Guidance documents that CDRH intends to publish in FY2017 & previously-issued final guidances for which CDRH is interested in receiving external feedback regarding whether these final guidances should be revised or withdrawn.

WHY: Per MDUFA III negotiations, to help get safe and effective medical devices to market more quickly

HOW:  3 lists

  • A List: To be published
  • B List: To be published  as resources permit
  • Retrospective review of 2007, 1997, 1987, 1977 documents

LEARN

 

Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

w

Connecting to %s