Listed with other top experts in: 

1996 to

(Undisclosed)

Principal Consultant

He provides a comprehensive range of regulatory and technical services including citation and interpretation of applicable FDA laws, regulations, guidances, and policies; compliance and testing strategies; preparation or review of device marketing submissions, required reports, and responses to FDA correspondence; preparation for FDA and advisory panel meetings; due diligence investigations; litigation assistance; and expert testimony. He represents both plaintiffs and defendents based upon the merits of the case.

1994 to 1996

C. L. McIntosh & Associates, Inc.

Senior Regulatory Consultant

His responsibilities were similar to those that he performs in his own medical device consulting firm.

1981 to 1994

Food and Drug Administration

CDRH Office of Device Evaluation

Director, Premarket Approval Staff

He oversaw the scientific, regulatory, and administrative review of Premarket Approval Applications from 1981 to 1990. As the Assistant Director for Reclassification and Compliance from 1990 to 1993, he was the liaison with the CDRH Office of Compliance re enforcement activities involving device marketing, labeling. advertising, and promotion. He was the primary resource for the Office of Device Evaluation and other FDA staff re FDA device laws, regulations, policies, and procedures.

1977 to 1981

Food and Drug Administration

Office of Small Manufacturers Assistance

Chief, Industry Servicies Staff

He and another individual established this office. It was mandated by the Medical Device Amendments of 1976 to provide technical and other nonfinancial assitance to promote industry understanding of, and compliance with, this legislation and the implementing regulations and policies. He was the principal FDA speaker on a wide variety of the legislative provisions at industry and FDA sponsored workshops and conferences. He was detailed to that office in 1993 and 1994 as the Associate Director for Regulatory Affairs. He was the senior adviser to the staff on FDA device marketing-related laws, regulations, guidances, and policies.

1972 to 1977

Food and drug Administration

Center for Drug Evaluation and Research

Chief, Inspection Review Staff

He oversaw the review of FDA inspections of methadone treatment programs and initiated enforcement actions as appropriate. He processed regulatory actions involving the submission to FDA of fraudulent drug-related information or the misuse of any drug that presented a serious risk to public health. During this period he served a 4-month detail as the Special Assistant to the CDER Director, He also servied a 4-month detail to the Division of OTC Drug Evaluation.

1966 to 1972

Food and Drug Administration

Baltimore and Philadelphia District Offices

Investigator (Drug Specialist)

He initially inspected manufacturers and distributors of a wide range of FDA regulated products before specializing in the inspection of drug manufacturers and clinical study investigators.

• In a number of litigation case he has demonstrated that medical device manufacturers have not complied with the FDA conditions of marketing approval re notifying physicians and surgeons of FDA imposed experience and training requirements and providing the required training.
• In a significant number of litigation cases he has demonstrated that medical device manufacturers have not complied with FDA requirements for investigating and reporting deaths, serious injuries, and malfunctions and taking appropriate corrective and preventive actions.
• In a number of litigation cases he has demonstrated that devise manufacturers have not complied with the FDA requirement to include in device labeling the FDA imposed experience and training requirements for users of their device.
• In several litigation cases he has demonstrated that alleged violations of FDA requirements in FDA warning letters or inspection findings did not occur or were the result of FDA misinterpretations of FDA requirements.
• In a significant number of litigation cases he has demonstrated that device manufacturers have submitted fraudulent information to FDA or have omitted material facts.

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