Michelle McDonough, MS
Michelle McDonough, Senior Associate, Regulatory Affairs, joined MCRA in January 2009 and is responsible for drafting, reviewing, and strategizing US and international regulatory submissions. Prior to joining MCRA, Michelle interned for the Orthopaedic Research Foundation of the Carolinas. There she assisted the Foundation with ongoing clinical research conducted in conjunction with the Steadman-Hawkins Clinic of the Carolinas. Michelle received her Bachelor in Science at Clemson University in Biochemistry and her Master in Science at Clemson University in Bioengineering with a focus on cartilage repair procedures in the knee.
Recent Posts by Michelle McDonough, MS
The December 2009 (applicable March 21, 2010) amendments made to the Medical Device Directive (MDD 93/42/EEC) require all medical device manufacturers to include a clinical evaluation in their European device technical file. A clinical evaluation is used to obtain and evaluate all available clinical data on the medical device or equivalent devices in order toContinue Reading
It is time to complete your annual establishment registration if you have not already done so. Medical device facilities should complete the registration process for 2012 between October 1 and December 31, 2011. The registration fee for fiscal year 2012 is $2,029 for all establishments including small businesses. Access to the FDA electronic registration andContinue Reading
FDA Releases Draft Guidance Documents: Classification of Products and the Definition of ‘Chemical Action’
The Food and Drug Administration recently released two draft guidance documents for review and comments detailing how it classifies certain products and defines the term “chemical action.” These guidance documents could be the beginning of a major shift in the way certain orthopedic devices are reviewed. Here are highlights from each: Classification of Products asContinue Reading