Jan 6, 2021

In June 2020, the US Food and Drug Administration (FDA) published a guidance document outlining the impact of the COVID-19 pandemic on meetings and user fee applications for medical devices. The agency updated the guidance in December to extend compliance deadlines for medical device companies with applications and submissions on hold.

Guidance update extends response deadlines and addresses virtual advisory committee meetings

Under normal circumstances, the FDA provides 360 days for sponsors to respond to a major deficiency letter for Premarket Approval (PMA) and Humanitarian Device Exemption (HDE) applications, while 180 days are afforded to respond to an additional information letter for 510(k) and De Novo submissions. The June guidance added 90 days to these timelines in recognition of the disruption caused by the COVID-19 pandemic, and the December update expanded this grace period to 180 days before an application or submission is considered withdrawn. An extension request is not required in order to take advantage of the extra time.

The updated guidance also confirms that the FDA is able to conduct advisory committee meetings virtually. The original publication only indicated that the agency was exploring how to implement such an option.

More options to substitute for on-site MDSAP audits now available to sponsors

The FDA also published a revised transmittal issued by the Medical Device Single Audit Program (MDSAP) Assessment Program Managers (APMs), expanding the range of alternatives to on-site audit arrangements available through the end of June 2021. A previous transmittal from June 2020 allowed for remote audits to substitute for on-site audits when travel restrictions or social distancing guidelines made physical visits impractical. The new release allows eligible Auditing Organizations (AOs) to employ remote audits, desktop audits, hybrid audits, or surrogate audits, depending upon the risk classification of the proposed activity. The transmittal provides a guide to identifying the risk classification of auditing activities,​ outlining eligibility criteria and requirements for the ​alternative audit arrangements.​

Related regulatory resources for US FDA and COVID-19:

Author

  • Timothy Herr

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