FDA offers guidance on meeting new medical devices tracking rules

By Gayle S. Putrich
Staff Reporter

Published: July 1, 2014 4:50 pm ET
Updated: July 1, 2014 4:54 pm ET

Related to this story

Topics Medical, Public Policy, United States

WASHINGTON — A final round of in-depth information on the new federal medical device identification database and tracking system is available from the U.S. Food and Drug Administration.

The guidance is meant to provide the technical how-to for the Global Unique Device Identification Database (GUDID), according to FDA, including how to obtain a GUDID account, how to register devices and packaging and how to edit or amend submissions.

In order to finalize the sections with the most questions from device and packaging makers, the GUDID Draft Guidance was completed in phases, the agency said. The first phase was released June 11.

Now, FDA reps said, the new, more-than-40-page-document contains the finalized version of all sections of the draft guidance. The final guidance includes — with minor modifications — the previous sections on how device labelers will interface with the database, establish accounts and begin submissions. The guidance also finalizes the sections on the device identifier record, product labeling submissions, search and retrieval of device information, and submitting and maintaining electronic records.

The finalized guidance also includes an appendix of packaging examples, said an FDA spokeswoman.

The agency has also provided information on how device makers can apply for an exception if the requirements of the new rule are not technically feasible for their device.

The new system is a two-pronged approach, requiring both a bar code for machine scanning and text that can be read by the naked eye on most medical devices. But manufacturers may also apply for an exception if an alternative identification method would provide “a more accurate, precise, or rapid device identification,” the agency says, or if a different labeling system would better ensure the safety or effectiveness of the device.

FDA issued the final rule in late September 2013 and the first compliance deadline, for Class III medical devices and their labels and packaging, is Sept. 24. One year after that, devices described in the FDA Safety and Innovation Act as “implantable, life-saving, and life sustaining,” which are mostly class II devices, have until September 2015.

The remaining Class II devices have until 2016 and by 2018, all non-exempt class I devices must also be compliant, according to FDA timelines.


Comments

FDA offers guidance on meeting new medical devices tracking rules

By Gayle S. Putrich
Staff Reporter

Published: July 1, 2014 4:50 pm ET
Updated: July 1, 2014 4:54 pm ET

Post Your Comments


Back to story


More stories

Image

Louisiana molder expands into former Yoo-hoo bottling plant

October 31, 2014 1:51 pm ET

Noble Plastics Inc. plans to expand its manufacturing capabilities with the purchase of a former Yoo-hoo bottling plant in Opelousas, La., eight...    More

Image

Hong Kong injection molding equipment maker enters US market

October 31, 2014 1:39 pm ET

Hong Kong-based L.K. Technology Holdings Ltd. is entering the North American plastics processing market with a line of its eXcel injection molding...    More

Image

Comco Plastics in bitter lawsuit with former VP

October 31, 2014 2:17 pm ET

Comco Plastics Inc. is suing a former vice president of sales, his wife, the company they started and a former supplier, in part for allegedly...    More

Image

Packaging veteran Piercy takes over at R&B

October 31, 2014 12:30 pm ET

R&B Plastics Machinery LLC, which makes blow molding machines and single-screw extruders in Saline, has named 21-year packaging veteran Fred Piercy...    More

Image

Using 3-D printing for molds to speed medical part development

October 31, 2014 10:17 am ET

3-D printing and additive manufacturing equipment maker Stratasys Ltd. is collaborating with U.S. design and product developer, Worrell Design Inc., t...    More

Market Reports

Pipe, Profile & Tubing Extrusion Market Trends

This report provides in-depth analysis of current trends, statistics and innovations in product design and production impacting the PP&T industry in North America.

Learn more

Plastics Recycling Trends in North America

This report is a review and analysis of the North American Plastics Recycling Industry, including key trends and statistics based on 2013 performance. We examine market environment factors, regulatory issues, industry challenges, key drivers and emerging trends in post-consumer and post-industrial recycling.

Learn more

Plastics in Mexico - State of the Industry Report

This report analyzes the $20 million dollar plastics industry in Mexico including sales of machinery & equipment, resins and finished products.

Our analysts provide insight on business trends, foreign investment, top end markets and plastics processing activity. The report also provides important data on exports, production, employment and value of plastics products manufactured.

Learn more

Upcoming Plastics News Events

January 14, 2015 - January 14, 2015Plastics in Automotive

February 4, 2015 - February 6, 2015Plastics News Executive Forum 2015

June 2, 2015 - June 3, 2015Plastics Financial Summit - Chicago 2015

September 16, 2015 - September 18, 2015Plastics Caps & Closures - September 2015

October 27, 2015 - October 29, 2015Plastics Financial Summit - New York - 2015

More Events