European Commission enacts new rules concerning Notified Bodies

Louise Zornoza reports on that on September 24, 2013, the European Commission issued new rules creating a new EU process for designating and monitoring Notified Bodies. The new rules establish the basis for withdrawal and clarify the required expertise of these groups. Notified Bodies are responsible for the oversight of local manufacturers of medium and high risk medical devices. There are currently 80 Notified Bodies in the European Union, which all conduct audits and issue CE markings for medical devices. The new rules describe the designation of a Notified Body as well as the monitoring of such body to reaffirm its compliance and use. For the full article and new rules, click here.

Brazil: ANVISA beginning to update and revise regulatory system

Stewart Eisenhart, of, explains that Brazilian medical device regulator ANVISA is planning a multitude of updates and revisions to Brazil’s existing regulatory system to be enacted by the end of 2014.  These proposed changes will affect almost all quality management system requirements and registrations currently in place.  Although none of the alterations have been enacted yet, the announcement of a list of medical device and in vitro diagnostic issues targeted displays ANVISA’s plan is coming to fruition. If all the changes are to be enacted by the end of 2014, Brazil will have more efficient, cost effective market access for foreign manufacturers. Do you think Brazil could begin to be a major player in foreign manufacturing in the next five years? For the full article click here.

FDA publishes final cGMP rule on drug, device and biological product combinations

The FDA published a final rule entitled Current Good Manufacturing Practice Requirements for Combination Products to provide clarification of cGMP requirements for products that are made up of a combination of devices, drugs and/or biologics. The new guideline applies to both already existing and new combination products, yet the FDA plans to issue guidance to help manufactures modify systems for products already on the market, as needed. The final rule also clarifies the cGMP requirements for “single-entity” and “co-packaged combination products.” To read an article in MassDevice, click here and to view the final rule on FDA’s website, click here.

Need help with regulatory interpretation of the new final rule? Contact us at

MWDG devision of ASQ Biomedical presents “Human Factors in Medical Device Development” in Indianapolis

The Midwest Discussion Group (MWDG) of the ASQ Biomedical Division presents Human Factors in Medical Device Development on Thursday, October 25, 2012. Jim Kershner from Eli Lilly will share his experience dealing with issues around human factors in medical device development. Kershner will share his extensive knowledge and hands-on experience on human factors investigations. The meeting will be held at the University of Indianapolis. Hot buffet, beverage and dessert will be served at this event.

When: Thursday, October 25, 2012

Where: University of Indianapolis, Schwitzer Student Center Building #7 Room #013 (on lower level)

Time: 5:30p.m. – 8:00p.m.

Cost: $12.50 for members, $15.00 for non-members

For full details of this event, click here.

FDA Not Meeting Medical Device Performance Goals?

According to a Government Accountability Office (GAO) report, FDA was inconsistent in its review of pre-market approval applications.  These findings were based on the years starting in 2003 and ending in 2010.  The report also said FDA was “especially” inconsistent with applications marked “expedited”.  In addition to inconsistency, the report also found that 510(k) submission times had increased 61%, from an average of 100 days to 161 days between 2005 and 2010, although the FDA still met performance goals for those applications.  To read more, click here.

BioPharm Int’l article presents recipe for CMO quality success

An article published this month by Susan J. Schniepp on BioPharm International illustrates the difficulty for contract manufacturing organizations (CMOs) in factoring in the quality priorities and needs of multiple clients into their own planning and operations.  The article attempts to identify a formula that could help define the quality relationship more clearly between CMOs and their clients, namely how to balance the quality commitments and regulatory obligations of both parties involved.

Schniepp identifies four basic variables (and no constants) that contribute to the landscape of the CMO quality relationship:

1) CMO’s needs,

2) compliance needs,

3) client’s needs, and

4) regulatory commitments.

Each of these four variables must be weighed and considered when drafting a quality agreement, and each must be clearly identified and thoroughly explained within the document.  According to Schniepp, “The Quality Agreement should be a living document that is reviewed and revised as often as needed to clarify the responsibilities of the client and the CMO as the product progresses through its lifecycle.”  In order to sustain a successful relationship, both the CMO and its clients must be very clear on the elements required for quality and compliance, and where those responsibilities fall in each case.  To read the full BioPharm article, click here.

At Pearl, we partner with our clients to assist them in building and managing the strongest quality compliance processes, including clearly defined vendor management systems and oversight, GMP audits, and more.  For a listing of our QA services, click here.  Or contact us at to discuss your 3rd party supplier selection and management needs today.

FDA adopts 8 new initiatives to enhance transparency of compliance and enforcement data

 The recently-released FDA report entitled, “[FDA] Transparency Initiative: Exploratory Program to Increase Access to the Agency’s Compliance and Enforcement Data,” announced 8 new initiatives adopted as part of FDA’s Transparency Initiative, launched in 2009 by Commissioner Margaret A. Hamburg, MD.

The exploratory transparency initiatives—of which draft proposals were published online and opened to public feedback in October of last year—should serve to promote the public’s understanding of FDA’s decisions and enhance the Agency’s accountability by making data more quickly and readily available, both to industry users and the general public.

The impetus for this report, and the Transparency Initiative in general, comes from Obama’s Presidential Memorandum on Regulatory Compliance, which calls for regulatory agencies such as the FDA “to make public information concerning their regulatory compliance and enforcement activities accessible, downloadable, and searchable online”.

To read more about the new transparency initiatives, click here.

France Pushing for Increased Inspection of Medical Devices

According to a report, French health Minister Xavier Bertrand has requested tighter controls for potentially faulty medical devices. This announcement came in the wake of the recent faulty breast implant scandal. The manufacturer of the implants was caught using industrial silicone which is cheaper to make and was banned in 2010. The implants with the industrial grade silicone have become known as PIP implants. France and other countries have recommended that anyone who has received a PIP implant have it removed.To learn more about the implant scandal, click here. To read more about the request for tighter control on implants in France, click here.

FDA Issues Report – Understanding Barriers to Medical Device Quality

On October 31, 2011, the Food and Drug Administration (FDA), Center for Device and Radiological Health (CDRH) released a report titled Understanding Barriers to Medical Device Quality (link to full report).  The initiative began in an effort to “assess and understand gaps in medical device quality” by gathering information through interviews with experts, internal and external, blinded industry interviews, a scan of databases, relevant articles, conferences and an outside press search.

The assessment discovered key facts about devices currently on the market along with areas for improvement in quality.  The key points from the reports show that the device industry has seen rapid growth in revenues and technical complexity over the last two decades, quality risks are not evenly distributed across the industry and failure in product design and manufacturing control caused over half of the recalls.  Recalls have increased, but the most noticeable increase is in adverse events when using devices.

The information from the companies who were interviewed by the FDA offered insight into how companies prioritize by putting compliance over quality in manufacturing.  Along with this problem, many companies see inconsistencies in application and interpretation between investigators and offices.  The goal of the FDA is to engage with the industry and provide transparency in reference to enforcement and increasing clarifications.