Medical Devices; Classification of Accessories Distinct from Other Devices; Proposed List of Accessories Suitable for Class I; Request for Comments.
As required by the FDA Reauthorization Act of 2017 (FDARA), the FDA has identified a list of accessories for which the Agency believes general controls alone are sufficient to provide reasonable assurance of safety and effectiveness, so the accessories could be in class I. The classification is based on the risks of the accessory when used as intended and the level of regulatory controls necessary to provide a reasonable assurance of safety and effectiveness.
Key factors the FDA considered for this proposal include:
- If the accessory is for use in supporting or sustaining human life, or of substantial importance in preventing impairment to human health;
- Whether the accessory represents a potential unreasonable risk of illness or injury; and
- If general controls alone would be sufficient to provide a reasonable assurance of safety and effectiveness of the accessory.
Design controls apply to class I devices only if the devices are automated with computer software or are listed under § 820.30(a) (2) (ii). Thus, if an accessory is not automated with computer software but would require design controls to provide reasonable assurance of safety and effectiveness, FDA did not consider it eligible for classification through the final action based on this document
The proposal also includes a policy clarification about certain accessories used in orthopedic surgery. Certain manual orthopedic instruments that are for use with other devices in orthopedic surgery meet FDA’s definition of an accessory described in the Accessories Guidance. This regulation pertains to “non-powered hand-held device[s] intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.” These devices are class I, subject to general controls, and exempt from premarket notification procedures, subject to the limitations of exemptions in 21 CFR 888.9.
You have an opportunity to review the list of accessories proposed for reclassification and submit your comments directly to the FDA.
Submit either electronic or written comments on the document by October 16, 2018.
Submit electronic comments in the following way:
- Federal eRulemaking Portal: https://www.regulations.gov Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov would be posted to the docket unchanged.
Submit written/paper submissions as follows:
- Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
- For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”