On February 21, 2018, the Food and Drug Administration (FDA) published a Final Rule, amending its regulations on acceptance of data from investigations for medical devices that are performed outside of the United States as well as modifying certain regulations applicable to data from US-sited investigations. The Final Rule does not go into effect until February 21, 2019 – a full year after promulgation. The FDA also issued guidance in the form of Frequently Asked Questions (FAQ) addressing the new regulations. In the FAQ document, the FDA explained its …
The U.S. Food and Drug Administration (FDA) announced that it was delaying until March 19, 2018, a Final Rule that has been viewed as having a chilling effect on scientific speech in attempting to broaden FDA’s authority to find an “intended use” for an approved or cleared medical product. FDA extended the effective date to allow additional public comments after a petition filed on behalf of various industry groups challenged the Final Rule (dockets FDA-2011-P-0512, FDA-2013-P-1079, FDA-2015-N-2002, and FDA-2016-N-1149).
In the Final Rule, FDA had amended the intended use …
The Centers for Medicare and Medicaid Services (CMS) recently issued a Final Rule to streamline and address the substantial backlog of Medicare administrative appeals at the Administrative Law Judge (ALJ) and Departmental Appeals Board (DAB)/Medicare Appeals Council levels.
Among other changes to the appeals process, the Final Rule:
- Permits the designation of Medicare Appeals Council decisions as precedential, in order to provide clarity
- Gives attorney adjudicators certain authority that had been previously reserved to the ALJs, including the authority to decide appeals that can be determined without a hearing, to