FDA issues final rule amending medical device classification regulations, excluding non-device software functions

April 16, 2021

The U.S. Food and Drug Administration (FDA) issued the final rule: Medical Device Classification Regulations to Conform to Medical Software Provisions in 21st Century Cures Act.

The final rule:

  • Amends eight classification regulations so the regulations conform to the medical software provisions of the Cures Act and reflect the FDA’s current statutory authority.
  • Amends the “identification” description of eight classification regulations so the regulations no longer include software functions that the Cures Act excluded from the device definition.

On Jan. 15, 2021, the Department of Health and Human Services (HHS) issued a notice in the Federal Register determining certain class I reserved devices to be exempt from premarket notification (also known as 510(k)) and proposing to exempt certain class II devices, along with one unclassified device type, from premarket notification.

In the interest of public health, HHS and FDA issued two notices in the Federal Register to explain HHS’s and FDA’s current view on the requirement for premarket notification for the medical devices included in the Jan. 15, 2021, notice.

• First Notice: Medical Devices; Class I Surgeon’s and Patient Examination Gloves – This notice explains that the class I surgeon’s and patient examination gloves identified in the Jan. 15, 2021 notice meet the “reserved” criteria in the statute and thus will require premarket notification. Comments on this notice may be submitted to the Federal Register docket within the 30-day open comment period.

Second Notice: Making Permanent Regulatory Flexibilities Provided During the COVID-19 Public Health Emergency by Exempting Certain Medical Devices from Premarket Notification Requirements; Withdrawal of Proposed Exemptions – This notice withdraws the proposed exemptions for the 83 class II devices and one unclassified device type that HHS included in the Jan. 15, 2021, notice. The devices within the scope of this notice will continue to be subject to premarket notification.

The FDA issued enforcement policies concerning certain devices in response to the COVID-19 public health emergency. These policies do not alter the legal obligation to comply with the relevant legal requirements and do not preclude the FDA from taking action to enforce those requirements where appropriate. Those policies, which are limited to the public health emergency and include risk mitigations, are different from the Jan. 15, 2021, notice.

Establishments seeking to market the Class I reserved devices classified with product codes OPC, LZC, OPH, OPA, OIG, LYY, and LYZ should comply with applicable regulatory requirements, including labeling and requirements for import into the United States.

More information about premarket notification is available on the Premarket Notification 510(k) page.

Federal Register has the notice.

More COVID-19 coverage HERE.