The Advanced Medical Technology Association, along with large device company Johnson & Johnson, are asking the FDA to further explain the regulatory approach of additive manufacturing, which includes 3D printing, according to a Med Device report.
Here are five things to know:
1. The FDA released "leap frog" draft guidance addressing design and manufacturing considerations and device testing considerations but then commented in May the document wasn't meant to address all facets of 3D printing technology for medical devices.
2. AdvaMed requested the FDA provide a separate standalone companion guidance for the patient-matched devices. The guidance should address additive manufacturing as well as other manufactured technologies like computer-controlled milling machines, according to the report. Data handling aspects of patient-specific information also needs further attention.
3. Johnson & Johnson posits that considerations for patient-matched devices are distributed throughout the current draft guidance, making it unclear whether the considerations are patient-matched specific or for additive manufacturing in general.
4. Developments in 3D printing could cause a surge of point-of-care manufacturing and needs additional regulatory guidance, according to the report.
5. AdvaMed called on the Center for Devices and Radiological Health to work with counterparts within the FDA to encourage guidance on 3D printing.