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New FDA Guidance for Medical Device Reporting for Manufacturers

On November 8, 2016, the FDA issued the long awaited final guidance, “Medical Device Reporting for Manufacturers.”  http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm359566.pdf  The final guidance addresses medical device reporting and recordkeeping requirements for device-related adverse events and certain types of device malfunctions.  The guidance supersedes the…

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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…

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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…

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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….

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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…

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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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The What, When, and How of Clinical Registries

Why a registry? Patient registries are an excellent data collection tool to use in today’s health care environment, particularly when there is a need to characterize or expand a patient population for a treatment, to develop new information which can be used…

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Early Feasibility Medical Device Clinical Studies

On October 1, 2013, the Food and Drug Administration (FDA) released a final guidance document, “Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies.” This guidance was developed to facilitate the early clinical…

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Counting Down: eMDR Compliance Deadline is Fast Approaching

As most companies and individuals in the Medical Device Industry are aware, on February 13, 2014 the FDA published a final report requiring manufacturers and importers to submit all Medical Device Reports (MDRs) in electronic format. The compliance date of August 13,…

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Deciphering the Unique Device Identifier (UDI) Code

Three letters have caused quite a stir in the medical device industry. U. D. I. What does it mean? How does a company comply with the new rule? Fortunately, Unique Device Identifiers are not as daunting as they first appear, and they…

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A Review of Regulatory Changes around the Globe

Since 2013, there has been a flood of changes to Medical Device regulations around the world. Many countries are attempting to modernize their regulatory controls over Medical Devices to allow for increased patient safety and greater access to medical devices. Staying abreast…

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New Medical Device Regulations in the European Union

Ever since the new EU medical device and IVD regulations were proposed in September 2012, the medical device industry has been attempting to gain a firm grasp on what they need to do to be compliant and prepared. There has been talk…

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Pathways for IDE Approval: Which Best Fits Your Needs?

There are several options for sponsors who are seeking IDE approval or FDA feedback regarding an IDE. Each option offers different benefits, depending on what type of trial the sponsor is seeking to initiate and how much time the sponsor is looking…

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De-Mystifiying the De Novo Process

The De Novo process was first introduced in 1997 with the implementation of the FDA’s Modernization Act (FDAMA). [1] It was meant as a means to reclassify novel devices of low to moderate risk profiles that were automatically deemed Class III because…

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