Navigation Links
New White Paper Helps Medical Device Manufacturers Apply New FDA Regs to Combination Products
Date:7/13/2010

AGAWAM, Mass., July 13 /PRNewswire/ -- A new free, white paper that guides medical device manufacturers in the complicated process of applying new U.S. Food and Drug Administration (FDA) regulations to combination products embedded with pharmaceutical or biologic components is now available from Microtest Laboratories (http://www.microtestlabs.com/combination-products-20/)

Combination products are a large and growing segment of the medical device market, with some analysts estimating they represent over 30% of all new product submissions to the FDA. As the market continues to grow, it is further compounded by the introduction of human tissue and cellular products (HCT/Ps) incorporated in combination products, which in turn, raise a host of new challenges for testing, sterilization, and contamination avoidance.

Over the past 12 months, the FDA has addressed the dichotomy of dual quality systems by developing streamlined regulations for Good Manufacturing Compliance. These regulations, designated as 21 CFR Part IV, are anticipated to become law by the end of 2010.

Once promulgated, manufacturers will be held accountable for compliance and the FDA will use it as a legal document for enforcement. In the new white paper titled, "Combination Products 2.0: Applying the New FDA Regulations," Steven Richter, Ph.D., President and Chief Scientific Officer of Microtest Laboratories, Inc., addresses the implications for manufacturers. (Download from: http://www.microtestlabs.com/combination-products-20/). In the white paper, Dr. Richter discusses:

  • The New Regulations
  • Determining Principal Mode of Action -- Device or Drug?
  • Stem Cells & Human Tissue in Combination Products
  • The Implications for Testing and Validation
  • An Example: Drug-Eluting Stents

"The new FDA regulations governing combination products are a major step forward for the industry. They apply to 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 IV closes the gaps in the 2004 guidelines and succinctly clarifies the process for establishing quality systems that ensure compliance and patient health and safety. The ability of manufacturers to understand, establish, implement reliable testing procedures will be critical in complying with these new requirements," Dr. Richter said.

Download a free copy of "Combination Products 2.0: Applying the New FDA Regulations" from http://www.microtestlabs.com/combination-products-20/.

Dr. Richter founded Microtest in 1984 after a distinguished career at the U.S. Food & Drug Administration. Under his leadership, Microtest provides the medical device, pharmaceutical, and biotechnology industries with premier testing and manufacturing support.

Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

About Microtest

Microtest 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's expertise and flexible processes 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.

Available Topic Expert(s): For information on the listed expert(s), click appropriate link.

Steve Richter, Ph.D.  |  https://profnet.prnewswire.com/Subscriber/ExpertProfile.aspx?ei=42622  


'/>"/>
SOURCE Microtest
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. New White Paper Helps Medical Device Manufacturers Validate Cleaning Processes
2. Make Meth Ingredients Prescription-Only Says Former White House Drug Spokesman Bob Weiner; Oregon Did and Cut Crisis by Half
3. Abbott Chairman and CEO Miles D. White to Present at Sanford Bernstein Strategic Decisions Conference
4. Dr. Robert B. Arnot Releases White Paper on the Silent Threat of H1N1 and Other Infectious Diseases
5. New White Paper Examines Advanced Mycoplasma Tests - How Real-Time PCR Analysis Helps Save Time and Money for Biopharmaceutical Manufacturers
6. Whitepaper From Mirial Explains how Visual Communication Technology can Improve Healthcare Services
7. BIA Publishes White Paper: ISO 9000 Role in Document Review, Emphasizes Quality Equals Defensibility
8. Society of Gynecologic Oncologists Issues White Paper on HPV Vaccines Impact on Cervical Cancer Prevention
9. ALP Life Sciences, LLC Announces Nanoveson(TM) Patent Filing and Whitepaper Availability on Proposed Therapy for Non-Alcoholic Fatty Liver Disease (NAFLD) and Comorbid Diseases
10. White Paper Explains Aspects of Testing From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product
11. White Nose Syndrome: Is Pennsylvania Next?
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/26/2017)... May 26, 2017  Endo International plc (NASDAQ: ... and CEO, will represent the Company in a fireside chat ... on Tuesday, June 13, 2017 at 10:40 a.m. PT / ... Resort in Rancho Palos Verdes, CA. ... event will be available on the Company,s website at ...
(Date:5/23/2017)... Calif. , May 23, 2017  Leaf ... most innovative medical devices for pressure ulcer prevention, ... the American Association of Critical Care Nurses, National ... May 22-25. The Leaf Patient Monitoring ... specifically for the hospital environment.  The system seamlessly ...
(Date:5/18/2017)... 2017  Two Bayer U.S. Pharmaceutical leaders received top ... recent 28 th Woman of the Year ... HBA,s longstanding mission of furthering the advancement and impact ... Cindy Powell-Steffen , senior director of brand activation ... Libby Howe , a regional business manager for ...
Breaking Medicine Technology:
(Date:6/23/2017)... ... June 23, 2017 , ... Goodcents Deli Fresh Subs today announced the opening ... 4210 SW 21st St. Topeka, Kan. 66604 (near 21st and Gage). It is owned ... owns three other locations in the Topeka and Bonner Springs, Kan. area. , ...
(Date:6/23/2017)... ... ... 21 Middle East and South Asia Leaders Selected as Eisenhower Fellows , ... society in 11 countries across the Middle East and South Asia to embark on ... knowledge and ideas with the leading minds in their fields. , For the ...
(Date:6/23/2017)... ... June 23, 2017 , ... American Farmer, will feature ... which is slated to air fourth quarter 2017. American Farmer airs Tuesdays at 8:30aET ... a Danish pharmacist, founded Chr. Hansen in Denmark in 1874 after a groundbreaking discovery ...
(Date:6/23/2017)... ... June 23, 2017 , ... All-Star Insurance, a family ... business clients throughout eastern Texas, is announcing the launch of a new charity drive ... cancer statistics in the United States reveal that an estimated 252, 710 new cases ...
(Date:6/22/2017)... (PRWEB) , ... June 22, 2017 , ... Plastic Surgery ... as a Top Doctor for 2017. Each year, research and information firm, Castle Connolly, ... winning the title in 2015, this marks the 3rd time that Dr. Canales ...
Breaking Medicine News(10 mins):