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.

If you are not currently receiving the newsletter and would like to be on our mailing list, please email us at Please put "Combo Product-Device News" in the subject line.

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

FALL 2015

Contents [click on links for full story]  


Hot Buttons for Reprocessing

CDHR Report Outlines Reduced Review Times for Approvals


WuXi AppTec's Analytical Chemistry Facility Receives ISO 17025:2005 Accreditation

Gordon Ely Elected Technical VP of IEST

Client Portal Offers Convenience and Efficiency


•  WuXi AppTec Technical Seminar on Biological Evaluations | October 8, 2015 | Hyatt Regency | Bethesda, Maryland
•  MD&M | November 4, 2015 | Minneapolis Convention Center |  Booth #910


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.


Hot Buttons for Reprocessing

Worst case conditions. Worst case devices. Validations.  Accumulation cycles.

These are just some of the hot buttons that get the FDA’s attention when it comes to reprocessing medical devices. 
The FDA put out its final guidances in March 2015, and since then has continued to aggressively monitor reprocessed devices. In an article published August 17, 20151, the FDA said they are actively working with industry experts, healthcare facilities, reprocessing personnel and related regulatory technical committees to reduce the number of contaminations found in the field.

The final guidances place emphasis on proper cleaning and cleaning validations that involve testing under worst-case scenarios and with consideration of human factors. All cleaning, disinfections and sterilization procedures need to be validated, and validation needs to be completed prior to FDA submission.

In the months since the release of the final guidances, a number of companies have found their original testing data rejected by the FDA and have turned to WuXi AppTec for help. Some of the reasons for these rejections include:

•  Not selecting worst case test soil

•  Not using worst case device

•  Not including accumulation cycles

•  Performing cleaning and disinfection together as one validation

Let WuXi AppTec help you keep current with regulatory trends. We have performed over 1500 reuse programs and, with our integrated approach, we can customize your testing program to successfully meet regulatory expectations.  Contact your Account Manager for more information.


1.  Reference:

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CDRH Report Outlines Reduced Review Times for Approvals

On August 14, 2015, CDRH released a report entitled, “FDA’s Role in Ensuring American Patients Have Access to Safe and Effective Medical Device Technology.”  The report details a combination of programmatic improvements and innovative approaches in clearing medical devices, and outlines reduced review times for 510(k) and premarket approval applications, as well as the reduction of Investigational Device Exemption (IDE) review times by roughly a year. 

The paper discusses initiatives and shows how the FDA’s medical device program has adapted to changes in the marketplace, scientific advances, and new technology—all under the existing flexible, risk-based framework for oversight of medical devices. 

A few key highlights from the report regarding the decrease in time-to-decision on device submissions:

  • 510(k)s:

The vast percentage of device premarket submissions received by FDA in any given year are 510(k)s. In fiscal year (FY) 2010, it took 132 days for a total time to decision on a 510(k). By FY 2014, total time had dropped by 13 percent to about 115 days.  In 2014, most branches were reaching decisions within 90 FDA days 90 percent of the time or better, with the lowest performing branch reaching 81 percent of its 510(k) MDUFA decisions within 90 FDA Days.

  • PMAs:

Original PMAs generally account for only about 1 percent of all device applications received by FDA. Average total time to decision in FY 2014 has decreased to 242 days from 352 days at its peak in FY 2009, for an improvement of 31 percent.  Performance has improved significantly, from a difference in total average days to final decision between the highest and lowest performing divisions of 633 days in FY 2008 to 197 days in FY 2014.

  • IDEs:

Median total time to full IDE approval decision has decreased by over a year, from 442 days in FY 2011 to 30 days in FY 2015. The percent of IDEs approved within two cycles increased from 15 percent in FY 2011 to 63 percent in FY 2014 and 72 percent in FY 2015.

  • De novo:

The average total time to final decision for de novo requests [510(k) plus de novo review] -- submitted after a device was found to be not substantially equivalent through the 510(k) process -- has been reduced from 992 days in FY 2010 to 300 days in FY 2014.


Customer Satisfaction:

In 2014, CDRH made providing excellent customer service a strategic priority. So it launched an effort to improve customer service that included staff training; surveys to assess customer interactions and measure customer satisfaction; and, based on feedback from customers, actions to improve the quality of activities and services.  As this FDA center has made improvements to its program, customer satisfaction has improved. In fact, its 2015 survey results show an overall 88 percent customer satisfaction rating, with the rating for the premarket program even higher at 93 percent.

WuXi AppTec’s regulatory experts selected these particular highlights from the CDRH report because they are likely to have the greatest impact on our customers. 

The full report from CDRH is available on the FDA’s website:

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WuXi AppTec's Analytical Chemistry Facility Receives ISO 17025:2005 Accreditation

WuXi AppTec's Analytical Chemistry testing facility in St. Paul recently received ISO/IEC 17025:2005 accreditation for technical competence in the field of chemical testing.  Specific services cited in the scope of accreditation are:  Inductively Coupled Plasma / Mass Spectrometry (ICP/MS); Inductively Coupled Plasma / Optical Emission Spectrometry (ICP/OES); Ultra Performance Liquid Chromatography / Mass Spectrometry (UPLC/MS); Gas Chromatography / Mass Spectrometry (GC/MS);   Residual Solvent Headspace Gas Chromatography / Mass Spectrometry (HSGC/MS); and Extraction.

The accreditation was received from the American Association for Laboratory Accreditation (A2LA), which conducted a review and field audit of the site.  

ISO/IEC 17025 standards specifically cover the competence requirements of testing and calibration laboratories.To obtain this accreditation, the laboratory must demonstrate competence in both management and technical requirements.  Management requirements cover the effective operation of a quality management system.  Technical requirements relate to the competence of staff, the correctness of testing methodologies, the adequacy of equipment, and the accuracy of results.  The laboratory must submit to a thorough review of its processes and procedures, including observation of actual testing being undertaken.  The lab must make use of the latest scientific and technical knowledge, conduct internal audits, demonstrate continual improvement, and communicate effectively with customers.  WuXi’s ISO/IEC 17025:2005 accreditation is for a renewable two-year period. 

A copy of the accreditation certificate — along with copies of other registration/accreditation certificates for WuXi AppTec U.S. sites — can be found on our website. Click here to view.

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WuXi AppTec's Gordon Ely Elected Technical VP of IEST

Gordon Ely, Senior Technical Specialist at WuXi AppTec, has been elected to a two-year term as Technical Vice President – Contamination Control of IEST (Institute of Environmental Sciences and Technology). In this position he will oversee all the work done by the approximately 30 working groups in the Contamination Control division that write the recommended practices related to cleanrooms and, in general, the control of various types of contamination. He will also serve as a member of the IEST Executive Board and as a member of the U.S. TAG for ISO/TC209, among other responsibilities.

Mr. Ely, RM/SM (NRCM), ASQ CQA, has been a member of IEST for nearly 20 years and involved with many of the organization’s working groups. Currently chair of two working groups and vice-chair for another, he also served previously as President of IEST and in an earlier stint on the Board in the role that he has now.  At WuXi AppTec, he works with the technical teams that provide testing services for controlled environments and consults with clients in the design of comprehensive testing programs, specializing in validations of sterilization processes and controlled environments.

IEST (Institute of Environmental Sciences and Technology)

IEST is the world’s leading contamination control standards development organization and the Secretariat for ISO/TC209. The organization’s mission is "To globally expand and communicate the knowledge of contamination control, nanotechnology facilities, and test and reliability. This is accomplished through the development of Recommended Practices and Standards by a community dedicated to professional collaboration, training, and education.”

WuXi AppTec’s Services for Controlled Environments

WuXi AppTec provides manufacturers with testing services designed to help validate, monitor, and ensure the integrity of GMP/controlled environments – from laboratory counters to cleanrooms to entire manufacturing facilities. With our many years of microbiological testing for medical product industries, plus our experience in operating our own in-house manufacturing facilities, we have the expertise to advise you in designing a custom testing program to meet your particular needs.

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Client Portal Offers Convenience and Efficiency

For client convenience and efficiency, WuXi AppTec provides a secure, web-based tool that enables online tracking of your in-process orders.  Our Client Portal features a secure username and password-controlled system entry, Secure Sockets Layer (SSL) protocol for data encryption, and a simple intuitive user interface that makes it simple to search for a particular project and view information on its status.   

Plus, the Client Portal is available 24/7, so regardless of time or place, and whether you are logging in from your office computer or mobile device, you are never more than a click away from its many time-saving features.

If you've never tried it before, get an introduction by viewing our Client Portal tutorial, available here on the Client Portal login page on our website.

Setting up an account is easy.  Just contact us at:  Provide your full name, your company email address, and the WuXi AppTec account name and (very important) account number.  It would be helpful also to put “Client Portal” in the subject line of your email.

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•  WuXi AppTec Technical Seminar on Biological Evaluations | October 8, 2015 | Hyatt Regency Bethesda | Bethesda, Maryland
•  MD&M | November 4, 2015 | Minneapolis Convention Center |  Booth #910

For more information, contact your WuXi AppTec Account Manager.

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