Medical Device News and Insights

Medical Device Consultants, Inc. Completes Successful FDA Inspection

Thursday, June 3rd, 2010 | Uncategorized | No Comments

Medical Device Consultants, Inc. (MDCI) underwent a routine surveillance inspection by the FDA March 3 through March 16, 2010, at its corporate headquarters.  Prompted by reinterpreted FDA regulations, the inspection revealed no significant concerns and no response was required.

This inspection of MDCI, a medical device and diagnostics contract research organization (CRO) involved in the conduct of clinical trials and regulatory services, was one of the first of its kind.  According to Michael Marcarelli, Director of the Division of Bioresearch Monitoring, Office of Compliance, Center for Devices and Radiological Health, in a presentation at the 2010 ACRP global conference entitled, “Outsourcing Medical Device Trials - FDA and Industry Perspective,” the FDA has embarked upon an initiative to improve the quality of clinical research through increased scrutiny of vendors that assist medical device companies in the conduct and reporting of FDA regulated clinical research.  This increased scrutiny is taking the form of routine, on-site inspections and data audits of a variety of vendors, including CROs, core labs, and others.

Previously, FDA inspections of medical device CROs were study-specific and, in essence, audits of specific safety and clinical data at CRO facilities.  The new interpretation of “inspection” in the Investigational Device Exemption regulation (21CFR Part 812.145) appears to extend the FDA’s jurisdiction to mandate access to the vendor’s quality system and all clinical study records.  Even though there is typically no transfer of responsibility from the sponsor to the CRO under the medical device regulations as stated in the background section of CDRH’s Bioresearch Monitoring Compliance Program 7348.810, FDA may now enter a CRO, request a listing of all applicable studies at the facility, select specific studies to review, and access all files as previously done in an announced, study-specific manner.

MDCI is pleased that no deficiencies were found during this inspection.  The experience was viewed as educational for all involved.  This initiative is another indication of the changing environment at FDA, as well as CDRH’s intention to raise the bar on clinical trial conduct and to improve the quality of safety and effectiveness data collected in support of new medical device product introductions.

Tags: BIMO, CRO inspection, FDA inspection

Haitian Earthquake Relief

Friday, January 22nd, 2010 | Uncategorized | No Comments

All of us at Medical Device Consultants, Inc.,  share in the shock and sorrow caused by the earthquake in Haiti.

MDCI and its employees are donating to Partners in Health, a Boston-based organization with over 20 years of on-the- ground experience of bringing medical personnel and supplies to Haiti.  There are many excellent groups providing relief to the people of Haiti.  If you wish to provide support, please consider PHI or one of the charitable organizations below.

• American Red Cross
• Doctors Without Borders
• Unicef

Our thoughts are with all the families affected during this ongoing crisis. Thank you in advance for your generosity.

Tags: american red cross, Doctors Without Borders, earthquake relief, haiti, partners in health, Unicef