Welcome to Boston MedTech Advisors

Through this newsletter we wish to share with you breaking news from the FDA. Changes have recently been made to the payment process for device establishment registration and medical device user fees. Also, a draft guidance concerning the establishment and operation of clinical trial Data Monitoring Committees has been issued. Boston MedTech Advisors provides this update as a courtesy to the medical device industry. 

Please call us at 781.407.0900 if you have any questions about the information in this newsletter, or if you would like to discuss our services.

Boston MedTech Advisors Europe

Boston MedTech Advisors Europe, GmbH, has been recently incorporated in Dortmund, Germany with operations directed by Dr. Michael Imhoff.

The office in Germany enables BMTA to better serve companies based in Europe and assist non-European companies to assess the European markets, launch and expand their sales and market positions or seek business relationships with European entities.

Workshop Announcement

Boston MedTech Advisors and ZAG/S&W LLP are cosponsoring a workshop titled Introducing and Growing Medical Technology Business in the USA - Pitfalls and Opportunities.

New trends in healthcare, increased political pressures and a complex legal environment are among some of the factors presenting unique challenges to early-stage and growing medical technology companies looking to operate in the US market or establish relationships with US corporations.
Seasoned executives and industry experts will provide an overview for chief executives, directors and investors of some of the key elements needed to navigate medical technology companies in their way to the US healthcare market.

The workshop will be held in Tel Aviv, Israel on November 16 and 17.

Regulatory Update

New payment process for device establishment registration, effective October 1, 2008

Places of business (also called establishments or faciilties) involved in the production or distribution of medical devices intended for use in the U.S. are required to register annually with the FDA.  There is a fee for annual establishment registration for some commerical entities.  All device establishments must complete their annual registration for FY 2009 by December 31, 2008.  Click here for information on who must register, list and pay the associated fees.

On  October 1, 2008 the FDA instituted a new payment process for the device establishment user fee.  Those required to pay the fee must first visit the Device Facility User Fee website and pay the fee before registering their establishment.  The User Fee for FY 2009 is $1,851.  There is no reduction for small businesses or any other group.

Once the user fee payment is made, device registration and listing requirements can be completed on the FURLS website (the FDA electronic registrations and listing system).  Click here for complete instructions on user fee payment and establishment listing and registration. 

Updated FDA Regulatory Submission Fee Schedule

The new FDA submission fee schedule for FY 2009 became effective on October 1, 2008. It reflects changes to the standard and small business fees for premarket applications and 510K submissions.

Click here to for complete information on medical device user fees.

CDRH Advisory Committee Meetings

FDA has announced the November and December meeting schedule for the following medical device panels:

• Orthopedic and Rehabilitation
• General and Plastic Surgery
• Immunology
• Anesthesiology and Respiratory Therapy
• Obstetrics and Gynecology

Click here for the complete schedule and additional meeting details.

New FDA Draft Guidance Document

Establishment and Operation of Clinical Trial Data Monitoring Committees

The FDA has issued a proposed guidance to assist sponsors of clinical trials in determining when a Data Monitoring Committee (DMC) is needed for monitoring a study and how such committees should operate. The guidance addresses the roles, responsibilities and operating procedures of DMCs, and describes certain reporting and recordkeeping responsibilities, including:

• Sponsor notification to the DMC regarding waivers
• DMC reports of meeting minutes to the sponsor
• Sponsor reports to the FDA on DMC recommendations related to safety
• Standard operating procedures for DMCs DMC meeting records

The FDA is accepting comments on the proposed guidance until December 8, 2008.

Click here to view the full Federal Register announcement.

About Boston MedTech Advisors

Boston MedTech Advisors assists medical technology companies and healthcare organizations in advancing their business by providing:

• Market analysis and business strategyBusiness development Regulatory affairs and clinical trials management Reimbursement and contracting strategies
• Financing support

Boston MedTech Advisors provides practical business services to:

• Established and growing medical technology companies
• Healthcare providers
• Universities
• Young organizations and entrepreneurs
• Private and institutional investors

To learn more about our organization and services, please visit our web site at www.bmtadvisors. com or call us at 781.407.0900.