Navigation Links
Nelson Laboratories Compliant With New FDA Medical Device Registration Requirement
Date:11/14/2012

SALT LAKE CITY, Nov. 14, 2012 /PRNewswire/ -- Nelson Laboratories (www.nelsonlabs.com) today announced compliance with the FDA Safety and Innovation Act (FDASIA) regarding updated requirements for the registration and listing of medical devices for contract sterilizers of non-exempt devices who do not commercially distribute product.

(Logo: http://photos.prnewswire.com/prnh/20120727/LA47745LOGO)

"Nelson Laboratories is committed to staying up to date on the latest regulations from the FDA," said Sherri L. Robbins, Nelson Laboratories Director of Regulatory Affairs. "Because we provide ethylene oxide batch release sterilization services for exempt and non-exempt medical devices, and do not commercially distribute product, we now fall under this regulation. Therefore, we have completed our registration with the FDA as a device establishment."

Part of this regulation change requires Nelson Laboratories to list the devices that they perform contract sterilization services on with the FDA. Contract sterilizers such as Nelson Laboratories can only complete a listing after the manufacturer has completed their own listing.

To know if you must register devices visit: http://bitly.com/d1zQgB

To continue receiving batch release sterilization services without delay, Nelson Laboratories' non-exempt medical device manufacturers need to register their devices on the FDA webpage that details "How To Register and List."

Before Nelson Laboratories can finish listing a device they will require the device exemption information for exempt devices, or for non-exempt devices, the 510(k), Premarket Approval (PMA) number and the proprietary marketed name of the device. Nelson Laboratories knows the importance of confidentiality and will always choose the "confidential" option when identifying the proprietary name of the device in FDA listing.

Anyone that has questions or needs additional guidance on registering a device can email Robbins at srobbins@nelsonlabs.com.

About Nelson Laboratories

Nelson Laboratories is a leading provider of full, life-cycle microbiology testing services. We are known for exceptional quality, but we look beyond the testing process and partner with you to achieve your long-term business goals. It's what we call The Science of Success™. It's transparency in the testing process. It's approachable experts that guide you through ever-changing compliance requirements. It's helping you mitigate risk, be first to market, and succeed with your customers. Learn more at www.nelsonlabs.com.

Contact:
Ryan Oaks
Snapp Conner PR
801-994-9625
ryan@snappconner.com


'/>"/>
SOURCE Nelson Laboratories
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Nelson Laboratories to Present Latest FDA Trends at MEDevice Forum San Diego
2. Ameritox Files Amended Complaint Against Millennium Laboratories For Injunctive Relief, Declaratory Relief and Damages
3. Millennium Laboratories Sponsors Educational Programs in Support of Safe Prescribing Practices at Regional Pain Society Conferences
4. Grant & Eisenhofer Represents Lead Whistleblower in Historic $1.6 Billion Settlement with Abbott Laboratories Over Off-Label Marketing of Antiepileptic Medication Depakote
5. Dave Zitnak Of Upsher-Smith Laboratories Named Branded Representative Of The Year By McKesson Corporation
6. New Data Support Role of Prometheus Laboratories Novel Assay in Optimizing IBD Treatment Management
7. Everett Laboratories, Inc. Files Patent Infringement Lawsuit Against Competitor Trigen Laboratories, Inc.
8. PeaceHealth Laboratories New Patent Addresses a Leading Cause of Death: Prescription Drug Abuse
9. Omega Laboratories Applauds the Adoption of Enzyme Immunoassay (EIA) by Major Hair Testing Laboratories
10. Court Preliminarily Deems Millennium Laboratories Press Release Misleading
11. Millennium Laboratories Wins Lawsuit: Ameritox Advertisements Regarding Rx Guardian and Rx Guardian CD Contain Literally False Statements
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/2/2017)... Oct. 2, 2017 Diplomat Pharmacy, Inc. (NYSE: ... Software and Consulting, LLC , and named its founder ... based in Tennessee , will operate ... expands EnvoyHealth,s service offerings for health care partners to ... "In an interoperable world, technology ...
(Date:9/28/2017)... CHICAGO , Sept. 28, 2017 Hill-Rom ... quarter 2017 earnings conference call and webcast on Friday, ... 8:00 a.m. (EDT) and ending at approximately 8:30 a.m. ... to discussing the company,s 2017 financial performance and guidance ... growth opportunities, initiatives to enhance operational performance, and long-range ...
(Date:9/25/2017)...  EpiVax, Inc., a leader in the fields ... announced the launch of EpiVax Oncology Inc., a ... cancer vaccines. EpiVax has provided $500,000 in seed ... technologies to the new precision immunotherapy venture. Gad ... as Chief Executive Officer. Gad brings over 25 ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... ... PurhealthRX , a leading Health and Nutrition Company, is announcing the ... spectrum CBD oil will revolutionize the rapidly growing CBD market by reducing the amount ... into liquid products, while reducing costs to end users. , The team of researchers ...
(Date:10/13/2017)... ... 2017 , ... Lori R. Somekh, founder of the Law Office of ... elder law and special needs planning attorneys. “Membership in ElderCounsel helps our office remain ... to network with elder law attorneys nationwide,” said Somekh. , ElderCounsel ...
(Date:10/13/2017)... ... , ... Many families have long-term insurance that covers care for a family ... for care if the client has a cognitive impairment diagnosis. , “What this ... often waived, so the benefits from their insurance start immediately,” said Mechell Vieira, owner ...
(Date:10/13/2017)... ... , ... Ellevate Network, the leading network for professional women, brought together some ... at their inaugural Summit in New York City in June. The event was livestreamed ... over 3 million. To watch the Mobilize Women video, click here . ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Yisrayl Hawkins, ... week that explains one of the most popular and least understood books in the ... cryptic and puzzling descriptions that have baffled scholars for centuries. Many have tossed it ...
Breaking Medicine News(10 mins):