USA – HHS pushes through last-minute policies impacting FDA

With just days remaining before the transition to a new administration, the Department of Health and Human Services (HHS) is pushing through policies that could impact the US Food and Drug Administration’s (FDA) regulatory oversight.
 
Last week, HHS announced it had finalized a rule that would cause its regulations to expire if they are not reviewed every 10 years, with some exceptions provided for medical device-specific regulations, food standards and over-the-counter drugs, among other carveouts.
 
HHS also announced on Monday that it was issuing two new policies aimed at lifting premarket review requirements for some medical devices and imposing reporting requirements on FDA pertaining to its review timelines for drugs.
 
Notices pertaining to all three policies were posted to HHS’ website with a disclaimer stating that the documents had been submitted to the Office of the Federal Register for publication but have not yet been published in the Federal Register