Category Archives: Medical

MEDICAL DEVICE STANDARDS- Can we shed a little light?

Sometimes identifying the standards that apply to your medical device can seem like looking down a dark tunnel.  Is that a light at the end, or a train coming towards you?  It could be both! 

Long ago and far away, clearance of a US device with FDA did not depend upon conformity to a standard.  FDA, believe it or not, didn’t recognize “voluntary” standards and according to regulation, only FDA could issue a “performance” standard. Some years back, the ice broke and certain standards for evaluation of a device became “recognized”.  One of the earliest was for the evaluation for biocompatibility (ISO 10993 Part 1), which took the place of the old “tripartite agreement”; and now we have a deluge of standards to consider for any new medical device. Soon the trickle became a roar and regulatory bodies began to see the wisdom of recognizing certain “peer reviewed” standards.

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Congratulations to Shaye Mandle, President and CEO (formerly known as LifeSciences Alley) and the board of directors for their sound decision to recapture the trade name:  MEDICAL ALLEY.  We were not happy when the name was changed about 10 years ago.  Theoretically the organization was supposed to benefit from a more inclusive name.  The change diluted the bragging rights of local medical device company members, since MEDICAL ALLEY served as the model for similar trade organizations supporting the medical device industry across the country! The name and the innovators associated with that organization are recognized in the Smithsonian, for crying out loud.   Before the name change, MEDICAL ALLEY had been the “go to” group for the FDA and Congress when the voice of the industry was to be heard.  A few of the well remembered events in MEDICAL ALLEY history included a visit by the Dingell Subcommittee to learn how to strengthen the quality system regulations for medical devices, a visit by Dr. Burlington hosted by Senator Wellstone that gave birth to the recognition of standards as part of the device evaluation process and a change in FDA’s control of export of medical devices under development.  And of course, who can forget the visits by one of the most controversial commissioners, Dr. David Kessler.   MEDICAL ALLEY volunteers have developed draft guidance documents for the FDA and participated on many different advisory committees to the agency for policy and practice.  Many, many more services and activities for medical device manufacturers and patients and hospitals are to the credit of MEDICAL ALLEY.  We hope this change represents a renewal of the organization’s commission. Paladin Medical, Inc. received the award for Outstanding Contribution to the Healthcare Industry in1992.

The Basics Of UDI’s: Important Information For Medical Device Companies To Know



As with every industry, the only constants in the healthcare industry are change and change. Rising costs, new regulations and more continually offer a new take on the industry. One of these new changes brought upon by the FDA is unique device identification or UDI.


The Basics & The Differences Of Unique Device Identification

The FDA has created UDIs in an attempt to adequately identify medical devices through the lifetime of the device, whether in distribution or use. The unique device identification system will be phased in over the course of many years. Once completed, the program will offer many benefits to the health care system.

Once fully implemented, UDIs will help to improve patient safety, facilitate innovation in the medical device marketplace, provide postmarket surveillance and much more.

As well, UDIs will allow for more accurate reporting, analyzing and reviewing of a number of events. Medical errors will by reduced through ease of access to precise information. The improved analyzing abilities UDIs provide will allow for a clear and concise way to track data.


What is GUDID and why will customers benefit from it?

Once a device is uniquely identified, there will be a label on most machines. Each label will be readable by humans and machines alike. Individuals who label each device will also submit information about certain aspects of each device to the FDA’s Global Unique Device Identification Database or GUDID.

This allows customers access to the information they would not have had otherwise, as GUDID is available to the public. Anyone can search and download information from GUDID at any time through AccessGUDID.


How do I get a UDI and where can I go to get more information?

All UDIs must be issued through a system that is operated by an FDA-accredited issuing agency. There is a process any applicant would go through when seeking a UDI. There are certain exceptions and alternatives to this fairly new rule, as the UDI system will take around 7 years to fully implement.

To get more information about UDIs and how they may change things, you can visit the UDI homepage on the FDA’s website.


What is the effective date for my device and how can I find that out?

As the UDI system is going to take 7 years to fully implement, the compliance dates for the system is fairly complicated. Each year certain classes of devices will require labeling, due to different sections of the legislation.

As the legislation was passed in September 2013, each year on September 24 different devices will be required to be properly labeled. Each device will be classified on a certain scale, usually consisting of the type of device it is. The main devices the FDA is looking at are implantable, life-saving and life-sustaining devices.

To find out more information about the types of devices, you can search the CDRH Product Classification Database here. If that doesn’t help you find the information you’re looking for, you can also find a list of how the FDA classifies these types of devices here.