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In order to finalize the sections with the most questions from device and packaging makers, the GUDID Draft Guidance was completed in phases, the agency said.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Now, FDA reps said, the new, more-than-40-page-document contains the finalized version of all sections of the draft guidance.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

RPC expansion provides the space needed for continued growth

September 22, 2014 11:46 am ET

MORGANTOWN, PA. — Success, over time, created a challenge for RPC Bramlage-Wiko USA Inc. in this rural Eastern Pennsylvania town....    More

Image

TenCate materials help new amphibious sport aircraft take off

September 22, 2014 4:13 pm ET

TenCate Advanced Composites is supplying materials used in a new consumer sport plane made by ICON Aircraft.    More

Image

Breakaway success in Hollywood means growth for Smooth-On

September 22, 2014 1:30 pm ET

With the company “bursting at the seams” according to its co-owner, Smooth-On Inc. is moving from an 80,000-square-foot facility to a...    More

Image

Consumers want more function, less waste from their caps

September 22, 2014 11:35 am ET

In our daily lives, we always want more from the products we use, and dispensing taps and fitments can be a key part of that equation.    More

Image

New medical firm buys Clairson Plastics

September 19, 2014 4:33 pm ET

Custom injection molder Clairson Plastics is being sold to a new start-up that plans to dive into the medical market with a new dialyzer, a key compon...    More

Market Reports

Plastics Caps & Closures Market Report

The annual recap of top trends and future outlook for the plastics caps & closures market features interviews with industry thought leaders and Bill Wood’s economic forecast of trends in growing end markets. You will also gain insight on trends in caps design, materials, machinery, molds & tooling and reviews of mergers & acquisitions.

Learn more

Shale Gas Market - Analysis of North American Region

This report highlights the impact of shale-based natural gas on the North American plastics market and features an in-depth analysis of production trends in the United States during 2013 and a forecast for 2014 and beyond.

Learn more

Thermoformed Packaging 2014 Market Review & Outlook – North America

This in-depth report analyzes economic and market trends, legislative/regulatory activity impacting supply and demand, business opportunities and threats, materials pricing, manufacturing technology, as well as growth strategies being implemented by thermoformed packaging companies.

Learn more

Upcoming Plastics News Events

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

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

More Events