Category Archives: Stay Current

3D: Printed Products: What FDA expects you to know

3D Printed Products:  What FDA expects you to know

 

The regulatory classification of your device will most likely be the same regardless of the manufacturing methods, but for 3D printed products (additive manufacturing) FDA stresses the importance of Design Control and therefore, design validation.  Some companies who have a Class I device may consider that the quality system regs (21 CFR 820) don’t apply to them but many Class I devices are not “GMP-exempt”.  And although Design Controls do not apply to Class I devices, process validation certainly still may [ref 21 CFR 820.70 and .75].

We recommend the use of a process flow chart to identify the steps in manufacturing that may involve the elements of 3D printing.  It is particularly important in the flow chart to identify any use of software in the process element.  Handing off data from one software system to another is one element of 3D printing where verification or validation may be required.  From this flow chart an pFMEA should be derived to assist in the understanding of risks associated with the process step.  This risk analysis then can pinpoint the nature of evaluation that may be necessary to assure process performance and a safe device.  Even if your product is Class I and exempt from Design Controls, it is prudent to understand that “design requirements drive the processes”.

An example of how a design requirement can drive a process requirement is the tolerance required for certain medical products.  For example, if we’re building an oral appliance that must fit around a patient’s teeth, the tolerance of the 3D printer will need to produce a part sufficiently refined to fit around the teeth.  Variations of a millimeter could mean the device simply won’t fit.  The FDA guidance points out that “pixilation” of features (where an otherwise smooth surface is printed as a series of steps) could be quite uncomfortable in a patient’s mouth.  FDA admonishes that for “patient-matched” devices, there should be a “clear understanding of clinically relevant design parameters, the pre-determined range of these parameters, and which parameters can be modified for patient-matching.”

When a medical or dental device incorporates patient imaging data, there are considerations to make, not the least of which is whether the minimum image features (such as image resolution) is adequate.  Some software includes a smoothing or image processing algorithm that can alter the output.  And manufacturers may need to keep in mind the time elapsed between the image and the manufacturing, since tissues and wound defects can change over time.  Understanding the “handoff” (known as file conversion steps) between the image software and the 3D printer is crucial.

Understanding the file format conversion steps will help you plan the level of validation that will be necessary.  By defining the crucial dimensions and geometry for your device and understanding how the file conversion might negatively impact the critical attributes and performance criteria will form the basis of the risk analysis and subsequent validation plans. This will also help to anticipate when revalidation may be required if the software versions were to change.

In our next installment we’ll decipher the elements of build preparation software and how it can have an impact on your device qualification. 

Additive 3D Printing we wrote the book…

Paladin Medical® wrote the book on 3D printed medical devices.

Well, not the book exactly, but the first 510(k) for a 3D-printed medical device.

Paladin Medical secured the Stratasys FDM MedModeler 510(k) #971290 as a radiological accessory.  Medical devices produced by 3D (additive) Manufacturing are the next big thing.  But the US FDA issued a guidance on December 5, 2017:  Technical Considerations for Additive Manufactured Medical Devices; and they have a lot to say.  If you are considering employing 3D manufacturing in any capacity for a medical device, including making changes to an existing device for which you might already have a 510(k), you need to contact Paladin Medical, Inc. early in your planning.

The December 2017 guidance speaks to FDA’s recommendations for testing and characterization for devices that include at least one additively manufactured component or additively fabricated step.  This is a very important distinction.  Even if your device only has a PART or a PROCESS STEP that involves 3D printing and you need to know what is in this guidance and how the guidance would affect the contents of your 510(k) submissions.

The guidance is divided roughly into two areas:  Design/Manufacturing and Device Testing.  The former considers quality system requirements and the latter is concerned with testing (and application content).  FDA considers that this guidance should be viewed as a supplement to any device-specific recommendations or FDA recognized standards.  This guidance DOES NOT address manufacturing using biological, cellular or tissue-based materials.  Such materials would necessitate additional regulatory considerations.  Suffice it to say, such products are going to require a good deal of head-scratching by FDA, as well as several different departments involved.  3D printing technology is not new to FDA, in fact they held a public workshop in 2014 to discuss the many challenges.  FDA’s considers that the very attributes which make 3D printing attractive (such as making patient matched devices from images and tortuous internal channels) pose challenges for assessing the final finished device.

Just as with any medical device the information, characterization and testing FDA will need to see in a submission will be dependent on how the device is used (intended use) and the risks associated with the use.  FDA gives us a hint for future submissions:  determine and justify which of their “considerations” are appropriate for your device based on the material and technology being used.  FDA acknowledges that a 3D printed device would likely follow the same regulatory path as a non-AM device, but if the 3D processes raise different questions or safety and/or effectiveness the applicant could be in for a surprise, and thus recommends a PRESUB meeting.  Another “hint” FDA provides for the content of a submission is to present how the 3D printing plays a role in the device, including how software is involved.  It is also wise to try to conform to FDA’s definitions in a submission.  These little tricks of the regulatory trade can smooth communication.

Future posts on this subject will break down FDA’s concerns into bite size pieces.  We’ll discuss whether or not putting 3D printing into an existing device could trigger a new 510(k), how 3D printing is a concern for Device (Design) Validation, and how important the evaluation of materials (and materials processing methods) could be to a successful FDA clearance.

 

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.

Read more ...

WELCOME BACK MEDICAL ALLEY!

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

PALADIN MEDICAL UDI CONSULTING

PALADIN MEDICAL UDI CONSULTING

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.