December 2008
Volume 12, Number 12
  Working to make Massachusetts the medical device capital of the world

Proven Process Medical Devices-Results Built In



LOGIC, A Product Development and Manufacturing Company

MassMEDIC Gratefully Acknowledges:
Proven Process Medical Devices and LOGIC sponsors of MassMEDIC News


MassMEDIC News - Analysis of Proposes Regulations - Mass. Pharmaceutical and Medical Device Manufacturer Code of Conduct

Dear MassMEDIC Member:

This issue of MassMEDIC News is devoted entirely to an analysis of the proposed regulations related to the Pharmaceutical and Medical Device Manufacturer Code of Conduct, which has been referred to as the "Gift Ban" law in previous communications. These proposed regulations were released last week and will be the subject of two public hearings (January 9 - Boston & January 12 - Worcester) and a comment period before final regulations are published in February or March.

This analysis was prepared by Pat A. Cerundolo of the Boston-based law firm of Foley Hoag, especially for MassMEDIC members. We are grateful to Mr. Cerundolo and his colleagues at Foley Hoag for quickly reviewing the proposed regs and presenting us with this report. I would ask that you review the linked document and provide MassMEDIC with feedback on how these regulations will impact your business operations.

MassMEDIC will present oral testimony at the public hearings before the Mass. Public Health Council on January 9th and will file written comments on the proposed regulations based on membership feedback. If you, or a representative of your company, plan to testify at either venue, please contact me at 617-414-1340 or sommer@massmedic.com.

To access the analysis, please click here.


Best Wishes for a Happy Holiday Season,

Tom Sommer
President

 


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MassMEDIC gratefully acknowledges the support of its Premium and Sustaining Members.

Premium Members

Accellent

BD

Boston Scientific Corporation

Cambridge Consultants

Covidien

Genzyme Corp.


Goodwin Procter, LLP

Haemonetics Corp.

Medtronic

Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

Nova Biomedical Corp.

Philips Healthcare

Smith & Nephew Endoscopy

Sustaining Members

ABIOMED, Inc.

Analogic Corporation

Brown Brothers Harriman & Co.

C.R. Bard, Inc.

Camstar Systems, Inc.

Candela Corporation

Codman and Shurtleff, Inc. A Johnson & Johnson Company

Cooley Godward Kronish LLP

D&R Products Company, Inc.

Deloitte & Touche LLP

Edwards Angell Palmer & Dodge, LLP

Ernst & Young

Fish & Richardson P.C.

Foley, Hoag LLP

Grant Thornton LLP

Greenberg Traurig, LLP

Gyrus/ACMI

Hamilton, Brook, Smith & Reynolds, P.C.

Health Advances, Inc.

Hologic, Inc.

K&L Gates

KPMG, LLP

LehmanMillet

LEK Consulting

Massachusetts Technology Collaborative


Medical Device Consultants, Inc.

Nixon Peabody LLP

Nutter, McClennen & Fish, LLP

Nypro, Inc.

PriceWaterhouseCoopers, LLP

PRTM Management Consultants

Ropes & Gray

Schwartz Communications, Inc.

Siemens

The Mullings Group

Wilmer Cutler Pickering Hale and Dorr LLP

Wolf Greenfield

ZOLL Medical Corporation



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