Eased FDA Enforcement Not Likely Permanent: Attorneys
Attorneys Benjamin Zigarelli and Elizabeth Conti (Mintz) say it is unlikely that the relaxed enforcement of medical devices during the Covid-19 pandemic is likely to become permanent following the crisis. “The FDA policies reducing certain regulatory strictures clearly state that such targeted enforcement discretion is temporary and will end as soon as the public health emergency ends,” the attorneys write in an online post. “In most cases the regulatory flexibility narrowly applies to devices that are already FDA-cleared or approved and that are modified in accordance with the relevant policy. For the policies that do apply to devices that are not cleared, approved, or legally marketed in the U.S., it is almost certain that FDA will not extend such enforcement exceptions beyond the duration of the public health emergency because the agency will need to reassert its oversight to assure the safety and effectiveness of such devices.”
The post also says that the emergency use authorizations in place are temporary by nature and set up specific indications and uses for the use of devices that are not otherwise cleared or approved for such indications. It therefore stands to reason, it says, that FDA would not allow such uses to continue absent premarket notification or submission of premarket approval applications, as applicable.
However, the attorneys say that the temporary regulatory flexibility is noteworthy in illustrating a possible trend FDA may continue during this public health emergency and may employ in future emergencies.
They say that while initially, the agency appeared to focus on creating regulatory flexibility for devices that could directly assist healthcare workers to treat Covid-19 patients, newer enforcement policies and emergency use authorizations “highlight a broader approach by FDA to authorize modifications to existing devices, or even new, not cleared or approved devices, that may enable evaluation and treatment of patients with and without Covid-19, and whose use may aid in slowing the spread of Covid-19 by limiting contact between different patient populations and between patients and healthcare workers.”
The attorneys conclude that the broader use of certain devices allowing remote monitoring or remote review of medical images may demonstrate to FDA that such devices may be used safely and effectively for such uses, thereby paving the way for more efficient premarket review processes for such devices in the future.