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 info@wuxiapptec.com. 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.

May 2013

INDUSTRY / REGULATORY NEWS

Recent worldwide regulatory actions could affect device testing considerations, PLUS new FDA draft guidance on ISO-10993 is released

On April 23rd, the FDA released a new draft guidance entitled “Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." This is a significant milestone as 1995 was the last year the FDA provided any written guidance to the medical device industry on overall interpretation of the ISO 10993 standards. It is intended that the new guidance will replace the G95-I document.

The FDA is seeking public comments, and several trade groups are planning to provide their input regarding the new document. Comments are being solicited until July 22, 2013.

The notice and a copy of the draft guidance can be found on the FDA’s website by clicking on the following link: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments

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

OTHER REGULATORY UPDATES

Summarized below are some of the other recent regulatory actions worldwide that could have an impact on medical device testing programs.

US FDA

The U.S. FDA’s Center for Devices and Radiological Health (CDRH) was very active during the past year. Throughout 2012, it released over 20 Draft, Finalized or revised Guidance Documents in support of its 2011 CDRH Plan of Action. Among the documents most likely to affect our clients’ testing programs are the following:

• Guidance for Industry and FDA Staff: Refuse to Accept Policy for 510(k)s
• Guidance for Industry and Staff; Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)
• Guidance for Industry and FDA Staff: eCopy Program for Medical Device Submissions
• Guidance for Industry and Food and Drug Administration Staff FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals
• Guidance for Industry and Food and Drug Administration Staff FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals

Additional Note: Effective January 15, 2013, the CDRH updated the Recognized Consensus Standards listing. Clients are cautioned to confirm use of the correct FDA Recognition Number when completing the FDA Form 3654.

EU

On September 26, 2012, the European Commission published proposals for two new regulations on medical devices and in-vitro diagnostic devices (IVDs), which will replace the existing three directives that regulate medical devices in the European Union (EU). Once the final wording of the regulation is published in the Official Journal of the European Communities, it will enter into force 20 days from date of publication and come into full effect three years after entry.

Japan

An official bilingual English and Japanese language version of the JMLHW standard, Basic Principles of Biological Safety Evaluation Required for Application for Approval to Market Medical Devices, was released in October 2012 and is available in a book format. Experts from WuXi AppTec’s staff assisted in the technical translation of this document. For information on how to obtain this updated standard, contact your WuXi AppTec Account Manager.

WuXi AppTec continually monitors the release of new or revised worldwide regulations, guidance documents (horizontal and vertical), and standards, ensuring we are always fully knowledgeable about the most current regulations and requirements so that we can best advise our clients regarding their testing programs.

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

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Colorants pose unique challenges for meeting regulatory requirements

Because colorants can potentially leach from a device and present toxicological risks, manufacturers may be asked by a regulatory agency to characterize the colorants in a device and to identify the associated risks. Some regulatory groups may ask not only for characterization of the leachability of the colorant but also a determination of the colorant’s levels of impurities. With our deep experience regarding colorants in a wide variety of device types, WuXi AppTec can help you design an appropriate study, interpret the results with a risk assessment, and work with you to answer regulatory questions. In creating a targeted, customized, cost-effective approach for your device colorant testing, one primary consideration will be whether the colorant is a pigment, a dye or both. (Dyes are generally described as organic-based, and pigments are generally described as metal-based.) Having the certificates of analysis for the colorants or other specific chemical information would be helpful when designing the testing program, however, we recognize that colorants are often proprietary and it can be difficult for manufacturers to gather much information about them. Even if you have little information regarding your colorant, Wuxi AppTec can work with you to determine the appropriate tests for leachability, possible impurities and toxicological risks.

To contact a WuXi AppTec Account Manager for more information, click here.

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TESTING / LAB NOTES

EO sterilization validation programs feature client-tailored service options

For EO sterilization validations, WuXi AppTec’s enhanced programs offer service options so clients can choose a level that best suits their particular needs – from testing alone to total management resulting in a complete validation package.

• Testing Services Only
  All the required laboratory testing is performed for the validation, along with any lot release testing to monitor process controls.
  

• Testing and Sterilization Services
  In addition to the required testing, hands-on coordination of the sterilizing services is performed, including all interaction with the sterilizer, and confirmation and verification of sterilization.
  

• Total Management of Your Validation
  In addition to the required testing and coordination of all EO sterilizing services, this turnkey option results in a final, audit-ready summary report manual complete with all the supporting documentation needed.
  

To contact your Account Manager and learn more our EO validation services, click here.

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NEW! WuXi AppTec “Services for Medical Devices” catalog

WuXi AppTec’s Medical Device Services team has compiled an updated catalog of our services for medical devices and combination products that provides detailed test descriptions, including sample requirements and turnaround times. The new catalog’s sections are available as PDFs for viewing/downloading on our website: http://www.wuxiapptec.com/med-dev_catalog.html.

Also available is a printed version in a three-ring, tabbed binder. To order a copy, email: meddevcatalogrequest@wuxiapptec.com. In the body of the email, please be sure to include your complete shipping address.

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MEETINGS / PRESENTATIONS / POSTERS

Scientific sessions held at SOT Annual Meeting

WuXi AppTec presented three scientific sessions at the 52nd Annual Society of Toxicology (SOT) meeting, held March 10-14 in San Antonio, Texas. The largest toxicology conference and exhibition in the world, the SOT meeting attracts more than 7,300 scientists and executives from industry, academia and government. As part of the five-day event, the latest scientific achievements in the field of toxicology are spotlighted through poster presentations, and both the Suzhou, China and U.S. divisions of WuXi AppTec held poster sessions.

Our three poster presentations were titled: “Comparison of Ophthalmologic Findings in Young Adult Crl: CD, SD, and Wister Han Rats” and “Oral Toxicity Study of the Novel Optimized HCV Protease Inhibitor in Rats and Monkeys” (both from WuXi AppTec’s Suzhou site); and “Characterization of the Immune Response in a Murine Anaphylaxis Model “ (from a collaboration between WuXi AppTec’s Philadelphia and St. Paul sites). The sessions were well received by the conference attendees and reflect our ongoing animal-model development efforts to meet the ever-increasing complexity of preclinical research.

Presentations made at IEST Annual Meeting

ESTECH, the 59th annual Technical Meeting and Exposition of IEST (Institute of Environmental Sciences and Technology), held April 29 – May 2 in San Diego, featured two presentations by WuXi AppTec Senior Technical Specialist, Gordon Ely, RM/SM (NRCM), ASQ CQA. The subjects of his talks were: “Environmental Monitoring of an Aseptic Cleanroom” and “Sanitizer Efficacy Studies.”

To contact a WuXi AppTec Account Manager and learn more about these posters and presentations, click here.

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