News for the Combo Product/Device Industries

WuXi AppTec sends out a periodic e-newsletter to our contacts in the combination product/medical device industry. To access previous issues, click here.

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For questions about any of these items or other information on WuXi AppTec's services, contact a WuXi AppTec Account Manager.


March 2014

Contents [click on links for full story]   


WuXi AppTec's Regulatory Affairs team continuously monitors the release of new and revised worldwide regulations and guidances. Staying at the cutting edge of the changing regulatory landscape, we can assist you better by providing assistance in designing testing programs that meet current regulatory philosophies.

To contact a WuXi AppTec Account Manager for more information or to be put in touch with one of our regulatory experts, click here.

U.S. Regulatory News

2013 was another very active year for the FDA’s CDRH, which released over thirty (30) draft, finalized or revised Guidances in continued support of its 2011 Plan of Action.  WuXi AppTec’s Regulatory Affairs staff continuously monitored the release of these Guidances and assessed their impact throughout 2013. 

In line with the 2011 CDRH Plan of Action, the general themes addressed by the Guidances are:

  • Administrative updates related to the device approval submission process
  • Updates/Clarifications regarding the performance and expectations of clinical studies
  • Device specific submission requirements updates/clarifications

The following general Guidances were also released:

  • Draft Guidance for Industry and Food and Drug Administration Staff – Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex
  • Guidance for Industry and Food and Drug Administration Staff – Medical Device Classification Product Codes
  • Draft Guidance for Industry and FDA Staff:  Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1:Evaluation and Testing
  • Draft Guidance for Industry and Food and Drug Administration Staff – Medical Device Reporting for Manufacturers
  • Draft Guidance for Industry and Food and Drug Administration Staff: The Applicability of Good Laboratory Practice in Premarket Device Submissions: Questions and Answers
  • Guidance for Industry and Food and Drug Administration Staff – eCopy Program for Medical Device Submissions
  • Draft Guidance for Industry, Tool Developers, and Food and Drug Administration Staff – Medical Device Development Tools


NOTE:  Effective January 30, 2014, CDRH updated the Recognized Consensus Standards listing (List #34).  The new list contains a number of updated biocompatibility standards that are important to know when completing FDA Form 3654 as part of your submission package.  Contact your WuXi AppTec Account Manager if you have questions or would like to talk to our experts about this update.


CDRH Report to Congress

On February 27, 2014, CDRH released its Report to Congress outlining its decision regarding the 2011 Device Modification Reporting Requirements Guidance Document.   As you may recall this Guidance was issued in 2011 with the intent of replacing the 1997 Device Modification Reporting Requirements Guidance.  With passage of FDASIA in July 2012, the 2011 Guidance was subsequently withdrawn after significant industry and congressional pushback.  

According to the Report to Congress:

“The Agency’s analysis has shown that although there are certain areas of its 510(k) device modifications policy that should be updated or revised, the 1997 Guidance is a solid foundation and should remain mostly unchanged.  Therefore, this report outlines the following plans for developing and issuing policy on when to submit a 510(k) for modifications to a legally marketed 510(k) device…"

The FDA still intends to provide additional clarification to the 1997 Guidance on device modification reporting requirements. It is anticipated that the additional clarifications surrounding when devices modifications require reporting will not be as extensive as outlined in the 2011 Guidance.

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International Regulatory News

The Chinese government State Council Executive Committee has approved a 2008 medical device regulation revision proposal submitted by the predecessor of the China Food and Drug Administration (CFDA).   This 2008 proposal included revisions that:

  • Changed medical device definitions and classification rules.
  • Included new measures to track device risk and quality of production.
  • Included adverse-event monitoring requirements.
  • Increased penalties for regulatory violations and non-compliance.

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Biocompatibility Test Request Form Improvements

We recently updated our Biocompatibility Test Request Form and changed it to a web-enabled format. Since its release, we have gotten some valuable feedback from clients and, based on that input, we have improved the form to better suit your needs.

The most significant change we made will allow data entered into the form to be retained from session to session by your browser. This means that you can partially fill out a form and come back to finish it, or, for your convenience in completing a new submission, find all of your info from a previous session still available. A "reset" button at the top of the form lets you clear all entered data so you can start over, if you like.

Other changes were made to improve functionality and add more automated short cuts. We believe you will find this version of the form even faster and easier to use.

You can access the form here:

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Important Viral Clearance Update

Over the past several months, the US FDA has increased its scrutiny of human- and animal-derived tissue products.  This includes products in the approval process as well as products already on the market. While the Draft Guidance clearly calls out animal tissue, the FDA reviewers are looking for viral safety data on all tissue types – in particular, evidence that the process steps providing viral inactivation and removal are robust and capable of a 6-log reduction of virus above the anticipated viral load, whether from one or multiple steps.   

WuXi AppTec has been performing viral clearance studies for tissue, medical device and biologics clients for over 20 years.  Our industry-leading capacity allows us to perform hundreds of custom studies to validate viral inactivation on a wide variety of tissues, and our high-titer, highly purified stocks are available in three grades – Ultra 1, Ultra 2 and Ultra 3. By using high-quality virus stocks in viral clearance studies, you get the most accurate assessment of your processes and dramatically higher total log-reduction values.

Let our experts help you design viral clearance risk assessments and studies to evaluate a variety of different clearance mechanisms to help you meet your project objectives. These mechanisms may include:  chemical inactivation employing alcohol, detergent, acidic or basic conditions; peroxide treatments; glutaraldehyde treatments; irradiation of final products; and custom proprietary steps.  Because some materials and treatments are highly toxic, we can recommend methods to reduce the level of toxicity and interference during the viral clearance study to be sure you have the most sensitive assay possible to help you gain clearance and minimize questions along the way.

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WuXi AppTec's Newest Facility:  Materials Characterization Laboratory

To meet the rapidly growing demand for materials characterization studies, WuXi AppTec is pleased to announce that we have already started construction on a new facility that will greatly expand our specialized laboratory capacities and capabilities.

The Phase I build-out of the new facility, scheduled to open in late summer, will comprise 9,500 square feet of laboratory and office space – tripling our current chemistry accommodations.  The facility will eventually house a total of 23,000 square feet of space.

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Environmental Monitoring

The FDA has been focusing on quality systems and they are not limiting their inquiries to new products.  Even established products and processes have resulted in 483s during routine inspections.  Are your clean rooms and manufacturing environments at risk?

To help you meet today’s high regulatory demands, WuXi AppTec’s experts can assist you in designing, implementing and maintaining a custom program to help validate, monitor and ensure the integrity of your GMP/controlled environments throughout your product’s life cycle.  Programs can be tailored to meet your specific needs:

  • Design of a customized environmental validation program
  • Full on-site support and environmental program management
  • Testing support for environmental programs with revalidation reminders
  • Expert consultants, testing media, and equipment rental for self-conducted validations

To contact a WuXi AppTec Account Manager and learn more, click here.

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