November/2007 Newsletter
Welcome to Boston MedTech Advisors
 
Through this newsletter we wish to share with you breaking news from the FDA.  For the first time foreign companies are eligible for a small business discount for some medical device user fees.  The FDA has also moved from a paper-based to electronic registration and listing system for all establishments.  Boston MedTech Advisors provides this update as a courtesy to those in 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.
Regulatory Update

New guidelines on establishment registration and device listings, effective October 1, 2007

Highlights include: 

  • Electronic registration and listing are required for all establisments 
    • Requires logging on to the FDA database
    • Account name and password have been mailed from the FDA to each company's contact person
  • Establishment registration is required annually.  The registration period is from October 1 to December 31 of each year.
  • All firms, except initial importers, must list devices at the time of their annual registration.
  • A Registration Fee is introduced for the first time.  The fee is the same for all establishments.
  • Allows 24/7 update using the electronic system.

The full FDA announcement can be downloaded at http://www.fda.gov/cdrh/registration/faq-092807.htm
New FDA Guidance Document 
 
Medical Device User Fee Small Business Qualification and Certification
 
This newly issued guidance provides detailed information on the process for qualifying as a small business.
  • Available for companies with "gross receipts or sales" of no more than $100 million for the most recent tax year (including subsidiaries).
  • Allows one-time waiver for the first premarket application (PMA).
  • Provides reduced fees for applicable medical device submissions and Class III device periodic reports.
  • Available to US and for the first time to foreign companies as well.
  • For foreign companies - requires certification by the National Taxing Authority (on FDA Form 3602A).

The full FDA guidance document can be downloaded at http://www.fda.gov/OHRMS/DOCKETS/98fr/07d-0401-gdl0001.pdf

About Boston MedTech Advisors

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

  • Market analysis and business strategy
  • Business 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
  • 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.

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Featured Article

New FDA guidelines for medical device companies.
 
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781-407-0900