Home  | About mdi |  Services  | Industries | News & Information | Partners | Contact| Site Map

A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Pre-market Procedures

The FDA has set up this guidance to assist the medical device industry and Food and Drug Administration (FDA) staff in implementing a voluntary pilot pre-market review program that may reduce the burden on manufacturers who face conflicting pre-market submission format and content requirements in different countries. The proposed pilot program will evaluate the utility of an alternative procedure for device pre-market submissions.

Be aware that the FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

The background on this is that the FDA is conducting a voluntary pilot pre-market review program and is soliciting participation from the medical device industry. The pilot program will be implemented by FDA's Center for Devices and Radiological Health (CDRH). It is intended to assess the feasibility of a proposed internationally harmonized format and content for receiving pre-market approval (PMA) applications and 510(k) pre-market notification submissions. The proposed harmonized format and content is described in the document entitled, “Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices,” otherwise known as the “draft STED document.” The document was developed by Study Group 1 (SG1) of the Global Harmonization Task Force (GHTF) and issued as a working draft in December 2000.

There is a list of devices that the FDA will allow to be used in this pilot program:

• Intravascular Catheters

• Administration Sets

• Anesthesia Catheters and Needles

• External Infusion Pumps

• Endosseus Dental Implants

• Surgical Drapes

• Hemodialyzers and Hemodialysis Catheters

• Plasma Cell Separators for Therapeutic Use

• Bone Densitometers

• Fluoroscopic X-ray

• Urological Catheters

• Computed Tomography Scanners

• Magnetic Resonance Imaging Devices

• ECG Monitors

• PTCA Catheters

• Coronary Stents

• Anesthesia Catheters and Needles

• Implantable Pacemakers

• Implantable Cardioverter Defibrillators

• Orthopedic Implants\

Others could be added by petitioning the FDA.

      If you have any questions on how these numbers effects your operations please contact mdi at info@mdiconsultants.com.

.S. AGENT SECTION

Home  | About mdi |  Services  | Industries | News & Information | Partners | Contact| Site Map