The third in our series covering FDA guidance on additive manufactured medical devices, the present article addresses matters related to the design and manufacturing process, including those related to connections between the additive manufacturing technology used, the steps of a manufacturing process, and design validation.
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to technical considerations for additive manufactured (AM) medical devices. The document is intended to provide additional clarifications regarding the regulatory requirements to be applied for medical devices manufactured with the use of 3D-printing technologies, as well as recommendations to be considered by manufacturers to ensure compliance thereto. However, the authority also mentions that an alternative approach could be applied, provided such an approach meets the respective regulatory requirements and has been agreed with the Agency in advance.
Design and Manufacturing Process: Key Points
First of all, the document provides additional clarifications concerning technical considerations related to the Quality System (QS) requirements in the context of medical devices manufactured with the use of additive manufacturing technology. At the same time, the FDA explicitly mentions that the scope of the guidance does not cover all regulatory matters related to the QS, hence, the recommendations provided therein should not be treated as exhaustive. Under the applicable legislation, for class II and class III devices, and select class I devices, manufacturers must establish and maintain procedures to control the design of the device to ensure that specified design requirements are met per 21 CFR 820.30 Design Controls. As further explained by the FDA, medical device manufacturers are obliged to duly implement and follow the procedures, including the validation process, to ensure that the final product meets the requirements outlined in the initial specification. In case it is impossible to verify the results of a process by the virtue of an inspection and test due to the nature of the product in question, the manufacturer shall duly implement the procedure ensuring validation of the process itself. Thus, it is the responsibility of a medical device manufacturer to develop and implement procedures ensuring that the medical devices manufactured with the use of AM technologies will operate as initially intended.
The authority additionally emphasizes that QS requirements remain applicable even if the device is exempted from premarket notification (510(k)) requirements. At the same time, certain medical devices are explicitly exempted from Quality System requirements, as set forth by the applicable regulations. In this respect, general QS requirements should be followed irrespectively of the manufacturing method used.
Moreover, the Agency also mentions that the applicability of specific technical considerations provided in the guidance should be determined on a case-by-case basis, as it could depend on the nature of the particular additive manufacturing technology used. Under the general rule, a medical device manufactured with the use of AM technology should comply with any requirements applicable for such devices manufactured ordinarily.
Manufacturing Process and its Steps
The authority acknowledges that there are several additive manufacturing technologies used to produce medical devices nowadays. Hence, to ensure the safety and effectiveness of a final product, it becomes vitally important to divide the manufacturing process into steps and assess each step separately. Furthermore, the Agency also encourages medical device manufacturers to provide a high-level summary concerning each important step of the manufacturing process. In particular, the information should include, inter alia, the following aspects:
- Description of the process; and
- Identification of the process parameters and output specifications.
Apart from this, the manufacturer should provide additional details regarding the way different steps of the manufacturing process impact each other, and also explain how this impact is considered. This also applies to the assessment of a cumulative effect of previous manufacturing steps. For sure, final testing should be undertaken to ensure the safety and effectiveness of the device. However, sometimes it is quite difficult to identify the roots of an error/failure, so it is important to have all the processes and steps duly documented to have additional information for such an assessment. The steps the manufacturer should pay attention to depend on the additive manufacturing technology used. Hence, the medical device manufacturer is responsible for ensuring the results of the manufacturing process meet the respective requirements.
The general approach to be applied to the manufacturing process should be similar to the one applied in the case of manufacturing medical devices ordinarily. In particular, the design requirements should be taken into consideration when developing the process. As further explained by the FDA, it is, therefore, important to identify key design parameters of [the] device, including, but not limited to, size range and available design or configuration options (e.g., range of angles between the trunnion and stem of the femoral component of a hip arthroplasty device).
As it was mentioned before, the scope of the present guidance does not cover any considerations concerning the manufacturing process, as the specific ones could be required due to the nature of the additive manufacturing process in question. Moreover, additional considerations could be required to address specifics of the Quality System requirements. In this respect, the authority refers to such documents as:
- The Global Harmonization Task Force Process Validation Guidance; and
- The Design Control Guidance for Medical Device Manufacturers.
Should the medical device manufacturers have additional questions regarding the regulatory requirements to be applied for additively manufactured medical devices they are responsible for, they may also contact the respective regulatory body – the Division of Industry and Consumer Education (DICE), Office of Communication and Education.
In summary, the present FDA guidance provides additional details regarding the technical considerations for additive manufactured medical devices and the way they should be applied depending on the device itself and the particular additive manufacturing technology used. The document also clarifies the requirements for process validation procedures to be developed and implemented to ensure the safety and effectiveness of final products.
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