FDA Reclassifies Certain Device Accessories to Class I
Posted 11 April 2019 | By
The US Food and Drug Administration (FDA) on Thursday published a final classification action that would reclassify eight types of medical device accessories to class I.
The decision to reclassify the accessories — the final list is the same as the proposed list
— is part of what’s required by the FDA Reauthorization Act of 2017
, which also reauthorized the user fee programs.
The final classification action will be effective on 13 May, and the complete list of accessories includes:
- Gastroenterology-urology accessories to a biopsy instrument
- Penile implant surgical accessories
- Ureteral stent accessories
- Biliary stent, drain and dilator accessories
- Suprapubic catheter accessories
- Implanted mechanical/hydraulic urinary continence device surgical accessories
- Air-handling apparatus accessory
- Corneal inlay inserter handle
In response to comments suggesting additional products be classified into class I, FDA said: “We have reviewed all product codes suggested for distinct classification into class I in response to comments and have determined that additional product codes identified are not appropriate for this list at the present time for one or more of the following reasons: (1) the accessory type is already distinctly classified; (2) the accessory is of a type that is already class I; or (3) insufficient information was provided to demonstrate that general controls alone will provide reasonable assurance of safety and effectiveness.”
But FDA also said that it intends to publish another proposed list of accessories that may be suitable for classification into class I in accordance with the statutory deadline of five years from the first such proposal.
In addressing the 18 comments submitted to the agency’s proposal, FDA explained why its existing policy concerning the classification of certain accessories used in orthopedic surgery should not be changed. The agency also noted additional product codes that were not included in the original proposal.
“The identified accessories intended for use with a penile prosthesis under product codes FAE and FTQ were within FDA’s intent, but the proposal did not make that clear. FDA has also clarified that penile implant surgical accessories suitable for class I include the cylinder insertion needle, device placement tool, tubing plug, and blunt needle. Additionally, implanted mechanical/hydraulic urinary continence device surgical accessories suitable for class I include the tubing plug and blunt needle. For both types of accessories, FDA has found that general controls alone provide a reasonable assurance of safety and effectiveness,” the agency said.
Key factors that FDA said it considered for this final classification action 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.”
Medical Devices; Classification of Accessories Distinct from Other Devices; Finalized List of Accessories Suitable for Class I