Regulatory Outlook
Aug 01, 2003
Originally Published MDDI August 2003 REGULATORY OUTLOOK Proving that medical products will remain biologically inert during use doesn't have to be...
Jul 01, 2003
Originally Published MDDI July 2003 REGULATORY OUTLOOK Return to Article: HIPAA's Influence on Medical Device Technology...
Jul 01, 2003
Originally Published MDDI July 2003 REGULATORY OUTLOOK The April compliance dates for the Privacy Rule have come and gone. Is your company meeting its HIPAA...
Jun 01, 2003
Originally Published MDDI June 2003 REGULATORY OUTLOOK It is rarely used and carries risks. But for sponsors who disagree with the scientific basis on...
May 01, 2003
Originally Published MDDI May 2003 REGULATORY OUTLOOK If a device meets certain criteria, clinical investigators in an IDE trial can seek Medicare...
Apr 01, 2003
Originally Published MDDI April 2003 REGULATORY OUTLOOK Getting Started with a Combination Product Part II: European Regulations The European Union adds...
Mar 01, 2003
Originally Published MDDI March 2003 REGULATORY OUTLOOK Overcoming the regulatory challenges in this ever-expanding field yields rewards. Barry S. Sall,...
Feb 01, 2003
Originally Published MDDI February 2003 REGULATORY OUTLOOK FDA's Regulation of Analyte-Specific Reagents Confusing and at times counterintuitive, the ASR rule...
Jan 01, 2003
Originally Published MDDI January 2003 REGULATORY OUTLOOK Common sense and care should guide the MDR filing process. Jeffrey K. Shapiro Hogan & Hartson LLP...
Jan 01, 2003
Originally Published MDDI January 2003 MEDICAL DEVICE REGULATION The newest medical device legislation will provide FDA with increased revenue and resources,...