News | May 20, 1999

Updated Edition of FDA Regulatory Guidance Manual Published

Biomedical Market Newsletter Inc. (BMN; Costa Mesa, CA) has released a newly updated edition of their FDA regulatory guidance manual. The 175-page special update, "Quality Systems Regulation (QSR)—1999," is available as a bound volume only from BMN, and can be purchased alone or together with the 500-page original edition (first published January 1997). The QSR applies to all manufacturers/distributors of any medical device, instrument, equipment test, biological, supply, or drug reviewed by FDA.

The 1999 edition includes eight important new unpublished documents:

  • Implementing the Mutual Recognition Agreement Between the US & European Community; Pharmaceutical GMPs & Medical Devices; Establishing a Public Docket & FDA Contact Points (March 9, 1999)
  • Likelihood of Facility Inspections When Modifying Devices Subject to Premarket Approval; Guidance (May 11, 1999)
  • Mutual Recognition of Pharmaceutical GMP Inspection Reports, Medical Device Quality System Audit Reports; Final Rule (Nov. 6, 1998)
  • Other FDA Good Manufacturing Practice Inspection Process Reengineering Initiatives (March 29, 1999)
  • Quality System Inspections Reengineering (May 3, 1999)
  • Quality Systems Inspection Technique Handbook; Draft (Oct. 1, 1998)
  • Report on Quality System Inspection Technique Study (April 26, 1999)
  • Spotlight on Quality Systems Inspections Technique (June 11, 1998)

For more information: David Anast, Biomedical Market Newsletter Inc., 3237 Idaho Place, Costa Mesa, CA 92626-2207. Tel: 714-434-9500. Fax: 714-434-9755.