JD Supra

FDA updates medical device user fee guidance for small businesses, tightening some rules for reductions and waivers

On July 31, 2025, the U.S. Food and Drug Administration (FDA) issued its final guidance document “Medical Device User Fee Small Business Qualification and Determination,” which supersedes its previous ...
JD Supra

Commonwealth Court Paves the Way for Workers’ Compensation Fee Agreements Pertaining to Prospective Medical Benefits by Declaring the Same “Per Se Reasonable”

A 20% Fee Agreement applicable to all workers’ compensation benefits, indemnity and medical, is per se reasonable and enforceable, regardless of whether the medical expenses have been incurred or will ...