Beckton, Dickinson and Co. (BD) and Roche Diagnostics are seeking clarifications and changes to the US Food and Drug Administration’s (FDA) proposed list of Class II medical devices to be exempted from premarket notification.
The comments follow the release in March of FDA’s draft list, which was released as part of a provision in the 21st Century Cures Act. The devices listed include lots of basic diagnostic tests and reagents, as well as other equipment like umbilical clamps, obstetrical forceps and certain types of ophthalmoscopes.
Roche applauded FDA’s exemption of certain analyzers and test and instrument systems, adding, "Certain assays, instrument platforms, and bioinformatics can now be cleared or approved independently rather than as a system, which promotes innovation across the diagnostics industry and gets patients access to important IVDs [in vitro diagnostics] in a more timely manner."
But Roche also seeks clarity from FDA on its "rationale for exempting only some analyzers and for its application of ‘limitations to exemption’ for diagnostics," and recommending the agency "exempt all analyzers to provide clarity and consistency."
Roche also strongly urges FDA to review its ".9" Limitation of Exemptions provisions more generally.
Under the Food, Drug and Cosmetic Act’s section 513(d)(2)(A), FDA is authorized to exempt certain generic types of Class I devices from the premarket notification [510(k)] requirement. The agency has exempted more than 800 generic types of Class I devices and 60 Class II devices from the premarket requirement, and the 510(k) exemption is with certain limitations, which are so noted in ".9" of each chapter.
"Technologies and device types that were new and innovative when the provisions were first written are now well-characterized. For instance, point of care devices are an accepted and integral part of medical practice, and these devices are often subject to strict performance standards. Yet, under the .9 provisions, these devices are categorically limited simply because they are utilized at the point of care. Limitations such as these are outdated and no longer reflect current scientific knowledge or medical advancements," Roche contends
BD, meanwhile, is seeking "a partial exemption from premarket notification for devices indicated for myelography procedures based on similarities and common features with devices indicated for arthrography procedures." The New Jersey-based company is also seeking partial exemption from premarket notification for kits featuring aspirating needles used in lumbar puncture procedures to collect cerebrospinal fluid and circumcision trays consisting exclusively of scissors and scalpels as their cutting devices and manometers.
In addition, BD seeks clarification from FDA on what devices or accessories could be categorized as "non-patient contacting catheter finger grips."
Medical Devices: Exemptions From Premarket Notification; Class II Devices; Request for Comments