New FDA Regulations Streamlining the Governance of Combination Products are Detailed in New White Paper

AGAWAM, MASS. — September 10, 2013 — New Federal Food & Drug Administration (FDA) regulations have streamlined the governance of combination products — medical devices embedded with pharmaceutical or biologic components. A new white paper titled "Combination Products 3.0: Applying the New FDA Regulations in 2013" discusses the implications for manufacturers. The whitepaper is available to download at http://microtestlabs.com/combination-products-30.

Combination products are a large and growing segment of the medical device market. Some analysts estimate they represent over 30% of all new FDA product submissions.

"Over the last 10 years, FDA regulatory centers have struggled with the changes and challenges that these new technologies present. For manufacturers, the convergence of drugs, biologics, and devices has created both a host of regulatory issues — and many exciting opportunities," according to Steven Richter, Ph.D, President and Chief Scientific Officer of Microtest Laboratories, Inc., and author of the new white paper.

The new FDA publication, "21 CFR Part 4 — Current Good Manufacturing Practice Requirements for Combination Products," revises regulations by establishing different categories of products. These included single-entity products (such as a drug-eluting stent) and co-packaged products (such as a packaged syringe and pharmaceutical). The rules also distinguished between a drug with a device, a biologic with a device, and a device with an HCT/P.

The new white paper discusses, in detail and example, how the new FDA rules guide a manufacturer into one of two approaches, depending upon the characteristics of their product.

According to Dr. Richter, "the FDA's new streamlined approach for regulating combination products is a big step forward for the practitioner. It applies parts of both the QSR and GMP quality systems in a way that makes sense for the unique characteristics of each combination product. 21 CFR Part 4 closes the gaps in the 2004 guidelines and succinctly clarifies the process for establishing quality systems that ensure compliance and patient health and safety.”

Download the new white paper, “Combination Products 3.0: Applying the New FDA Regulations in 2013,” from http://microtestlabs.com/combination-products-30. The white paper is presented by Microtest Laboratories, a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries.

Based in Agawam, Mass., the company provides expertise and flexible processes that enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information about Microtest Laboratories, visit microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow Microtest Laboratories on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

New Medical Device Polymer Biocompatibility Screening Test Using Zebrafish Embryos to be Discussed at AMI's Medical Grade Polymers 2013

AGAWAM, MASS. – September 3, 2013 – A new test that utilizes Zebrafish (Danio rerio) embryos to screen plastics, composites, and polymers for toxicity in medical device manufacturing will be featured at AMI’s Medical Grade Polymers 2013 technical conference in September.

“The U.S. Food and Drug Administration (FDA) requires testing to assess medical device toxicology and describes which situations may trigger the need for manufacturers to repeat testing or undertake new programs. The dynamics of such testing are rapidly evolving,” according to Steven Richter, Ph.D., president and scientific director of Microtest Laboratories, and a former FDA official.

Dr. Richter developed the new “ZET™ Medical Device Polymer Biocompatibility Screen Test,” at Microtest Laboratories for use by medical device manufacturers and bio-material researchers.

“Zebrafish are extensively used in drug development studies due to their transparent embryos and fast development times. The Zebrafish test demonstrates similarities to mammalian models and humans. Its unique approach to fast-track medical device toxicity screens will save manufacturers time and reduce expenses,” he said.

“Moreover, Microtest’s ZET Test sensitivity has proven to be greater than the USP gold standard test for BPA. In addition, the benefits of ZET surpass both USP cytotoxicity testing and mouse embryo toxicity tests,” he said.

Dr. Richter will present details of the new ZET Test in his presentation, “Biocompatibility Testing: Past, Present, and Future,” on Tuesday, Sept. 17, at 10:10 a.m., at the Applied Market Information LLC (AMI) Medical Grade Polymers 2013 conference. The conference runs Sept. 17-18, at the Crowne Plaza, Boston/Woburn, Mass. For more information, visit http://goo.gl/o9edjx.

For more information about Microtest Laboratories’ new ZET Test, download the white paper, “New Medical Device Polymer Biocompatibility Screening Test Using Zebrafish Embryos (Danio Rerio),” from http://www.microtestlabs.com/zebrafish-test-paper.

About Microtest Laboratories

Microtest Laboratories is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., the company provides expertise and flexible processes that enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.