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White Paper

Boston Biomedical Associates Announces FDA eCopy Services

The FDA’s eCopy requirements for medical device regulatory submission has presented a plethora of new challenges and pitfalls for manufacturers who are trying to navigate the FDA’s regulatory process. If a company is not experienced with the process and requirements, a submission…

White Paper

What is an ICER and Why Should You Care?

The healthcare environment is changing rapidly and at all levels.  Value used to be defined as the number of procedures, products, or patients.  That is no longer the case and the challenge is therefore to define value, particularly where there are existing…

Fact Sheet

CDRH Modular PMA Alert – Process Changes

The FDA’s Center for Device and Radiological Health (CDRH) has issued a memo to modular PMA Holders regarding the implementation of PMA process changes that went into effect on June 13, 2016. The memo addresses how incoming Modular PMA submissions will be…

News & Events

Upcoming Events in May & June

May 26, 2016 Lauren Baker, PhD, President and CEO of Boston Biomedical Associates, will present a talk on US FDA regulatory issues for individuals in the medical device and biotech industry.  Her presentation, “Current Regulatory Trends at the CDRH and the CBER…

White Paper

Changes to Medical Device Regulations in China

The Chinese medical device market and regulatory landscape has undergone a myriad of changes in the past few years. China’s Medical device requirements have been extensively revised; in 2013, the Chinese Food and Drug Administration (CFDA) released 107 new medical device standards….

News & Events

BBA Announces Sponsorship of Medical Development Group

April 10, 2016 BBA is proud to sponsor the Medical Development Group (  The MDG is a community of professionals committed to advancement in the Medical Device and Medical Technology Industries.  Their mission “to contribute to the continuing development of medical devices…