Navigation Links
Nelson Laboratories Compliant With New FDA Medical Device Registration Requirement

SALT LAKE CITY, Nov. 14, 2012 /PRNewswire/ -- Nelson Laboratories ( 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.


"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:

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

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

Ryan Oaks
Snapp Conner PR

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:
(Date:6/24/2016)... 2016  Arkis BioSciences, a leading innovator in ... durable cerebrospinal fluid treatments, today announced it has ... is led by Innova Memphis, followed by Angel ... investors.  Arkis, new financing will accelerate the commercialization ... release of its in-licensed Endexo® technology. ...
(Date:6/23/2016)... a startling report released today, National Safety Council research ... proven plan to eliminate prescription opioid overdoses. Prescription Nation ... tackling the worst drug crisis in recorded U.S. history, assigned a ... , New Mexico , Tennessee ... failing states, three – Michigan , ...
(Date:6/23/2016)... June 23, 2016 Bracket , a leading ... next generation clinical outcomes platform, Bracket eCOA (SM) 6.0, ... June 26 – 30, 2016 in Philadelphia ... Clinical Outcome Assessment product of its kind to fully integrate ... Bracket eCOA 6.0 is a flexible platform for electronic ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... ... legally blind and certified personal trainer is helping to develop a weight loss fitness plan ... fix the two major problems leading the fitness industry today:, , ... They don’t eliminate all the reasons people quit their exercise program ...
(Date:6/25/2016)... ... June 25, 2016 , ... Experts from the ... AcademyHealth’s Annual Research Meeting June 26-28, 2016, at the Hynes Convention Center in ... topics including advance care planning, healthcare costs and patient and family engagement. , ...
(Date:6/25/2016)... ... June 25, 2016 , ... The temporary closing of Bruton Memorial Library on June 21 ... brings up a new, often overlooked aspect of head lice: the parasite’s ability to live ... not a common occurrence, but a necessary one in the event that lice have simply ...
(Date:6/25/2016)... , ... June 25, 2016 , ... First Choice ... States, named Dr. Sesan Ogunleye, as the Medical Director of its new Mesquite-Samuell Farm ... Medical Director of our new Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical ...
(Date:6/25/2016)... ... 25, 2016 , ... Dr. Calvin Johnson has dedicated his ... implemented orthobiologic procedures as a method for treating his patients. The procedure is ... to perform the treatment. Orthobiologics are substances that orthopaedic surgeons use to help ...
Breaking Medicine News(10 mins):