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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. 

Counterpoint Opinion Exchange: Medical Device Tax Deserves Criticism

The Star Tribune published (October 15, 2013) the editorial submitted by Elaine Duncan in response to a previous op-ed concerning the medical device excise tax.  This counterpoint editorial took exception to cynicism towards the bipartisan support to the repeal of the tax and clarified that the tax was not just a tax on medical device companies but in reality a tax on recipients of medical devices.  Here is Elaine’s editorial and the link to the referenced pro-tax article  .  The blogs on this site certainly support Elaine’s observation that the justification for the tax as a punishment to medical device companies underlies much of the rancor against repealing the tax.  Please continue to write your Congressman and support the repeal of the medical device tax when it comes up again later this year.

Paladin Medical will help you establish systems that ensure compliance as well as improve efficiency and productivity.

A Brief History of the Paladin

The modern meaning of the word “Paladin” is a heroic champion and strong supporter or defender of a cause. It is derived from the Latin “palatines,” meaning “of the palace,” and came to mean a warrior or knight. The twelve knights of Charlemagne were called Paladins; their mission to solve disputes between the king’s subjects.

In the late 1950s, a television character on the popular Western “Have Gun Will Travel” was named Paladin. He solved problems with intellect, not gunfire. The knight symbol on his business card conveyed his message of stoic service.