CMS and FDA Announce New Parallel Review Process for Medical Products

(Robert F. Church et al., Hogan Lovells)

On September 17, 2010, the Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA) issued a notice describing a new, voluntary parallel review process under consideration by these agencies for medical products.1 Although still in the early stages of its development, it represents a potential opportunity for new technologies, particularly those that would face coverage challenges after FDA approval, to pursue affirmative coverage on a more expedited timetable than currently available. The agencies have provided some details about the parallel review process, and seek comments on a number of aspects of the contemplated parallel review process, which must be submitted by December 16, 2010. The agencies also discuss a small pilot program for the parallel review process. Read more here.

Medical Devices Reimbursement Workshops – Winnipeg & Edmonton, Sept 20-23

(FAITC)

Date: September 20-23, 2010
Location: Winnipeg and Edmonton, Canada

Contact: Cynthia Stevenson, Trade Commissioner (Health Industries), Canadian Embassy, Washington, D.C. cynthia.stevenson@international.gc.ca

One-day workshops in Winnipeg and Edmonton for medical device companies on developing a market strategy that integrates reimbursement, the FDA regulatory process, securing investment/VC partners, and successful commercialization through appropriate business partners and distribution channels.

FDA Pre-Market Approval Workshops – Toronto & Montreal, Sept.21-23

(FAITC)

Date: September 21 to 23, 2010
Location: Toronto and Montreal, Canada

Contact: Cynthia Stevenson, Trade Commissioner (Health Industries), Canadian Embassy, Washington, D.C. cynthia.stevenson@international.gc.ca

Two specialists from the FDA’s Center for Devices and Radiological Health will present day-long workshops to Canadian manufacturers of medical devices and technologies and supporting institutional stakeholders that are approaching completion of product development with intent to export to the U.S. in the near term. The workshops address in-depth the requirements for Pre-Market Notification (510(k)) and Pre-Market Approval (PMA) procedures for the importation of medical devices and technologies into the U.S.

CE Certification Workshops – EU Medical Devices Market, September

(DFAIT)

The Trade Commissioner Service invites you to participate in upcoming workshop: ‘How to successfully gain access to the EU market’ – CE-Certification for Medical Devices, in Toronto, Montréal and Vancouver.

The seminar covers critical information such as:
• Overall description of the European “Global Approach”
• Description of the different conformity assessment procedures (Modular System)
• Special Requirements of Medical Devices Directive
• Outsourcing of processes; subcontracting, OEM/Private labelling

These workshops are designed to provide Medical Device companies with an overview of the EU regulatory system. Manuela Ahlers, an expert with TÜV NORD CERT GmbH has been invited to give you the know-how to systematically seek regulatory approval for your medical devices. Ms. Ahlers expertise will prepare you for exporting your product to the EU market. This will be an interactive full day workshop where breakfast, lunch and refreshments will be served.

One-on-one consultations will be made available. The Trade Commissioner responsible for the Medical Devices sector in Germany, Monika de Villiers (Monika.devilliers@internatinal.gc.ca) will also be available to answer your questions regarding the European market.

The workshop in Toronto will take place on September 8, 2010 – for more information please contact: anona.lukawiecki-vydelingum@international.gc.ca or Diane Cote (MEDEC) dcote@medec-aits.org, Gilles Chatelain, (EDT) Ontario Ministry of International Trade and Investment, Gilles.Chatelain@ontario.ca.

The workshop in Montréal will take place on September 10, 2010 – for more information please contact: Heloise.Cote@international.gc.ca

The workshop in Vancouver will take place on September 13, 2010 – for more information please contact: Wendy.Trusler@international.gc.ca

FDA Urges Medical Industry to Prevent Cargo Thefts

(UPI)

The U.S. Food and Drug Administration sent a letter to medical firms Wednesday, expressing concern about cargo and warehouse thefts of FDA-regulated products. FDA Acting Assistant Commissioner for Regulatory Affairs Michael Chappell said the stolen products have included prescription and over-the counter medicines, medical devices, vaccines and infant formula.

In the letter Chappell asked the industry to review and strengthen security practices. “There have been several cases where patients experienced adverse reactions from stolen drugs, reactions that were most likely due to improper storage and handling,” Chappell wrote. “We do not want to see this increase in thefts continue.” Read more here.