On May 10, 2016, the Food and Drug Administration (FDA) released a document entitled, Technical Considerations for Additive Manufactured Devices: Draft Guidance for Industry and Food and Drug Administration Staff. The publication of this document marks the first foray of the FDA into potential regulation of devices that use additive manufacturing as a means of fabrication of medical devices. Additive manufacturing is a broad term that encompasses 3-D printing as a means of creating functional medical devices. The guidance document has been published in order to solicit public comment regarding the FDA’s current thinking on the topic of 3-D printing and “is not intended to be a binding document on either the FDA or the public.”
The bulk of the document relates to specific considerations that Additive Manufacturing devices need to address in order to assure that they meet the Quality System requirements of 21 CFR section 820.198 (good manufacturing practices). The document, which specifically mentioned the conference on 3D devices FDA conducted on October, 2014, does make a few important things clear:
- Standard FDA requirements, e.g. 510(k), premarket approval, and investigational device exemption requirements apply to additive manufactured devices. Likewise the classification regulations for products are referenced as specifically applicable.
- If the device classification provides for exemption from either 510(k) or 21 CFR Section 820.198; quality standards, those exemptions would appear to apply when the device is fabricated using an AM process. However, it is noted that some aspects of 21 CFR Section 820.198 quality system requirements, e.g., maintenance of complaint records apply to virtually all devices, even those exempted (via published classification regs) from some other aspects of 21 CFR section 820.198.
- The document mentions apparently more stringent requirements which may be applicable to AM devices that are, for instance, used as implants, or which are load-bearing.
The draft guidance may ultimately not have a very substantial impact on all O&P devices. FDA places medical devices into one of three regulatory categories: Classes I, II, and III. While medical devices (including most O&P devices) that are manufactured using 3-D printing processes will be subject to the same exemption from most FDA regulation as Class I devices manufactured in a more traditional manner, AOPA believes that the publication of this document remains a significant development. The publication of the document clearly indicates the intent of the FDA to ultimately regulate the 3-D printing process in regards to its use in the manufacture of medical devices.
Some Class I O&P devices have been designated by FDA as exempt from either premarket notification [section 510(k)], or many aspects of GMPs, i.e., Quality Systems rules, or both. It is clear from this FDA notice that whatever rules apply to traditional O&P devices will also apply to similar devices fabricated using 3-D techniques and introduced for sale/commerce. So, while one or both of these specific exemptions may have been identified for a specific 3-D fabricated O&P device, it is important to note that the FDA continues to require manufacturers of all Class I devices to register with the FDA through its device establishment registration process. In addition, Class I device manufacturers are almost never exempted from FDA general requirements on record keeping and maintenance of complaint files. While some Class I O&P devices have been designated as not being subject to more rigid regulation such as the 510(k) pre-market notification process and complete compliance with all aspects of Good Manufacturing Processes (GMPs), in addition virtually no one is exempted from complaint record rules under the GMPs, and failure to comply with the record keeping and complaint file requirements could lead to trouble for both traditional O&P manufacturers as well as those that incorporate 3-D printing into their manufacturing process.
The FDA guidance document is a total of 28 pages, most of which focus on suggested quality systems and basic manufacturing processes that should be followed when using 3-D printing as a means to manufacture completed medical devices. While this guidance is more relevant to ALL Class II and Class III devices, and to some Class I O&P devices, it is a valuable resource regarding the intent of the FDA to ensure that 3-D printed medical devices do not pose a danger to the public. Even though FDA has couched this as a guidance document and non-binding, no one could read this document and conclude that all aspects of FDA’s medical device regulation and structure are not seen by the agency as applicable to Additive Manufacturing Devices that are offered for sale to patients/consumers/public.
Individual manufacturers of O&P devices that currently use, or intend to use additive manufacturing as part of their manufacturing process should familiarize themselves with the specifics of the guidance document. Areas of focus of the guidance document include sections on device design, software workflow, material controls, process validation and acceptance, quality data, device testing including both mechanical and material testing, cleaning and sterilization, biocompatibility, and labeling considerations.
The guidance document discusses, in detail, the differences between the manufacture of standard size devices and patient matched devices and the design alterations that must be made to accomplish both manufacturing styles. The document also highlights the need to ensure that the software that is used to convert a digital design into a physical device is efficient and not subject to error through file conversion. The guidance document then provides information on making sure that the materials used to create the medical device are appropriate both in material and structure, especially regarding implantable or load bearing devices. The guidance document continues by discussing the importance of process validity to ensure that using different machines to fabricate the devices will not result in significant alteration of the device itself. The document closes by discussing the need to not only assure the quality of the finished device, but also to ensure that the device is properly tested to confirm its effectiveness.
The complete document may be viewed here.
The FDA will accept public comment on the draft guidance document until August 8, 2016 (90 days from the publication date of May 10, 2016. Electronic comments may be submitted through http://www.regulations.gov and written comments may be submitted to the following address:
Food and Drug Administration
Division of Dockets Management (HFA-305)
5630 Fishers Lane
Rockville, Maryland 20852
AOPA will be preparing comments and will share them with AOPA members prior to submission.