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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 (http://www.mdgboston.org).  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…

White Paper


Environmental and Social Considerations for Medical Devices

In recent years regulators and law makers have given increased attention to ensuring that manufacturers of products sold in the United States, EU, and worldwide are socially and environmentally responsible. In this discussion, the Restriction of Hazardous Substances (RoHS) Directive and The…

White Paper


The New World of CER/CRBA Review

Recent experience has suggested that notified bodies are becoming more critical in their review of clinical evaluation reports (CER) or clinical risk/benefit analyses (CRBA).  The format “suggested” in MEDDEV 2.7.1 r3 is now the expected.  What does that mean to you?  It…

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