Dear Readers:
This has been a busy spring for FDA-regulated industries, as FDA moves to implement the recent FDA Modernization Act as well as past amendments to the law such as DSHEA. The growing international nature of regulation means that companies must also look to rules and regulations in other markets as well. For example, the medical device industry is facing two important deadlines in Europe and the US: The end of the European Union's 5-year transition period for compliance with CE marking (although the EU is considering a second transition period for unmarked products on the market before the deadline) and, closer to home, FDA's rule establishing required records and reports to FDA of corrections and removals to devices which goes into effect this month.
On the food side, after several years of ad hoc decisions, FDA has proposed criteria for identifying permissible "structure or function" claims for dietary supplements. As expected, the proposal confirms FDA's increasingly broad view of therapeutic intent and many FDA interpretations will no doubt be hotly contested. Only cosmetic products, whose FDA office has been drastically reduced, have escaped significant Agency actions this season.
These and other reports appear in this newsletter and, in addition, we are fortunate to include two reports from our Health Care Department, one concerning proposed changes to Medicare coverage decisions for medical devices and the other on HHS's recent decision to broaden the range of permissible conduct by wholesalers and manufacturers under the Antikickback Statute.
As always, we welcome your questions and comments.
Sincerely,
Emalee G. Murphy
Articles in this Issue:
Extended Transition Period for Medical Devices Placed on EU Market Prior to June 14, 1998
HCFA Considers Improvements for Medicare Coverage
FDA Keeps Cosmetics Program in CFSAN
FDA Releases More Draft Guidances for Medical Devices
Drug Discounting Pricing Arrangement Gets HHS OIG Approval
Final Rule for Medical Device Reports of Corrections and Removals Becomes Effective
FDA Proposes Dietary Supplement Rule for Structure/Function Claims
Appellate Courts Reconcile Lower Court Rulings on 180-Day Market Exclusivity
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