Extractables and leachable testing required by FDA for many medical devices

ANN ARBOR, Mich. — The U.S. Food and Drug Administration (FDA) requires extractables and leachables testing for many medical devices.  Due to the increased demand for extractable, leachable and drug compatibility testing in medical devices, NSF Pharmalytica has added six additional scientists specializing in analytical testing, method development and validation to help companies achieve 510(k) compliance.

Required by the FDA's Center for Devices and Radiological Health (CDRH), extractables and leachables testing impacts pre-market notification requirements for many medical devices. The recent changes made to the FDA’s 510(k) have resulted in questions on how to address the request for extractables, leachables and drug compatibility data.

Scientists at NSF Pharmalytica, a GLP and GMP contract laboratory, will play a key role in assisting companies with 510(k) market compliance. New hires include:

  • Bethany DePaul, Scientist II
  • Matthew Johnson, MS, Scientist II
  • Kerry Medovich, Scientist III
  • Zemelia Miller, Scientist I                                          
  • Amanda Pires, Scientist I
  • Edie Wagner, Scientist I

“Helping companies meet FDA compliance to 510(k) by testing for extractables and leachables in medical devices is part of our expertise. Each scientist helps to ensure clients receive effective, timely and cost-effective solutions to all of their testing needs including 510(k),” said Jim Scull, Ph.D., NSF Pharmalytica General Manager. NSF Pharmalytica is part of the Health Sciences Division of NSF International, a global independent public health organization that writes standards, and tests and certifies products for the health sciences, water, food, and consumer goods industries.

Editor’s Note: NSF Pharmalytica’s Director of Research Kurt Moyer, Ph.D., will present at an extractables and leachables conference: Toxicological and Biochemical Challenges in Packaging and Delivery, January 24-25, 2013 in Palm Springs, California.

Dr. Moyer also will present on extractables and leachables requirements at MEDTEC Europe on February 28 in Stuttgart, Germany. Mike Ruberto, Ph.D. will present a course on extractables and leachables requirements in pharmaceutical development on March 5th in Minneapolis and on March 7th in San Francisco.

If you would like to set up an interview with an NSF Health Sciences expert, email houlahan@nsf.org.

The NSF International Health Sciences Division offers training and education, consulting, auditing, GMP and GLP testing, certification, R&D and regulatory guidance to the pharmaceutical, biotechnology, medical device, over-the-counter and dietary supplement industries throughout the product lifecycle.

For more information on NSF International’s Health Sciences services, contact hs@nsf.org, 617-342-3625 or visit www.nsf.org/services/by-industry/health-sciences.

About NSF International (www.nsf.org): Based in Ann Arbor, Mich., USA, NSF International is a global independent public health organization that writes standards, and tests and certifies products for the food, water, health sciences and consumer goods industries. Established in 1944, NSF is committed to protecting human health and safety worldwide and operates in more than 150 countries.

The NSF Health Sciences Division offers training and education, consulting, auditing, GMP and GLP testing, certification, R&D and regulatory guidance for the pharmaceutical, medical device and dietary supplement industries throughout the product lifecycle. The division also supplies pharmaceutical secondary reference standards, traceable to USP and EP standards. NSF wrote the only accredited American National Standard (NSF/ANSI 173) that verifies the health and safety of dietary supplements and also tests and certifies products to this standard. The NSF Health Sciences Division operates globally throughout North America, Europe, the Middle East, Africa, Asia and Latin America.

NSF International offers ISO 13485 registrations for medical devices and CE marking delivered through NSF International Strategic Registrations, Ltd. (NSF-ISR), as well as drinking water filtration certification through the NSF Global Water Division. Additional services include safety audits for the food and water industries, environmental and sustainability services through NSF Sustainability and training courses through NSF Training and Education.