Creeping Toward Compromise: Draft Device User Fee Pact Possible This Month
This article was originally published in The Gray Sheet
Despite several holdups in user fee negotiations, progress appears to be picking up and FDA hopes to reach a draft agreement with industry by the end of August.
You may also be interested in...
The Institute of Medicine committee charged with reviewing FDA's 510(k) device pre-market review program is urging the agency to ditch the 35-year-old program and start fresh.
FDA is taking another stab at giving device companies advice on how to tell if a change they make to a 510(k)-cleared product warrants a new pre-market submission.
Device industry representatives are demanding that FDA release more details about what resources will be required to support planned regulatory reforms before they will map out a final user fee reauthorization agreement.