FDA and Internationally Regulated Medical Devices History

Experience with U.S. FDA and International Regulations

In 1977, STAT-A-MATRIX professionals worked with the newly formed Bureau of Medical Devices, U.S. FDA (now called the Center for Medical Device and Radiological Health, CDRH) to develop and introduce a new regulation for medical device companies in the United States. Three STAT-A-MATRIX staff members first presented this new regulation to industry-at-large at a conference for 600 attendees in Cherry Hill, NJ.

As a direct result of the conference, STAT-A-MATRIX was asked to work with the U.S. FDA to rewrite the Good Manufacturing Practice (GMP) regulations, the precursor to the current cGMP/Quality System Regulation.

Link to FDA Industry Services

The rewrite process took approximately one year. In March 1978, STAT-A-MATRIX professionals, U.S. FDA regulators, and several members of industry held 13 two-day conferences on the GMPs that were presented throughout the United States to more than 3,000 FDA employees and medical device industry attendees. These conferences were designed to explain the new GMP regulation through lecture and applications workshops where the U.S. FDA learned what the medical device industry needed and wanted from these types of government regulations.

Based on these conferences and workshops, STAT-A-MATRIX professionals and U.S. FDA regulators rewrote several sections of the GMPs and issued new regulations in December 1978.

As a result of key inputs into these regulations, STAT-A-MATRIX was asked by U.S. FDA regulators to help the FDA train industry as well as FDA investigators on how to audit against the new regulation. In 1980, STAT-A-MATRIX presented three training programs specifically developed for U.S. FDA and attended by FDA investigators and medical device industry personnel.

This successful program led to a long-term contract for STAT-A-MATRIX with the U.S. FDA to teach FDA investigators “Basic Food and Drug Law,” which was repeated often over the next 20 years.

Since 1980, STAT-A-MATRIX has been assisting medical device and pharmaceutical manufacturers in implementing quality and regulatory requirements. The support includes annual regulatory compliance training, proactive initiatives to ensure compliance, and crisis management when there are more serious issues with compliance.

Currently, STAT-A-MATRIX provides regulatory consulting and technical services support for companies seeking guidance and understanding of national and international codes, directives, regulations, and standards as they apply to medical devices and pharmaceuticals. The team has active, expert knowledge of current and proposed regulations and provides practical interpretations of both U.S. and European requirements.

STAT-A-MATRIX (SAM) has provided FDA regulatory consulting, coaching, and support for more than 30 years to medical device manufacturers of all sizes—from Fortune 50 companies to start-ups.

• SAM has trained thousands of personnel in pharmaceutical and medical device GMPs and assisted numerous companies in GMP compliance programs.
• SAM worked with several major North American and multinational medical device and pharmaceutical organizations in their ISO 9001 and ISO 13485 efforts, CE marking and product certification, new product approvals, GMP compliance, process validation, and total quality integration and improvement.
• For a worldwide manufacturer of precision medical devices and instruments under a consent decree, SAM was engaged in a long-term multinational effort aimed at bringing 13 designated sites into compliance with FDA GMP 21CFR820.
• SAM has successfully assisted scores of companies with 483 and warning letter issues.
• SAM has trained thousands of ISO 9000 and GMP auditors and lead auditors at public courses and on-site seminars, including registrar personnel.
• SAM FDA consultants have practical, industry experience in medical devices and pharmaceuticals, including former FDA investigators, AAMI board members, standards developers, Baldrige Examiners, and internationally acclaimed conference presenters.

Because we are a leading worldwide consultant in Lean Six Sigma and Operational Excellence, we integrate whatever we recommend for regulatory compliance into a company’s ongoing continual improvement processes. Hence, our goal is not simply to develop systems that will withstand audit, but to help our clients develop effective systems that will enhance quality, productivity, efficiency, and profitability.