FDA Will Not Require Supplements or 30-Day Notices for Some PMA or HDE Device Changes During Pandemic
For the duration of the COVID-19 public health emergency, the FDA does not intend to object to limited modifications to the design or manufacturing of medical devices approved through either premarket approval (PMA) applications or humanitarian device exemptions (HDEs) without prior submission of PMA or HDE supplements or 30-day notices.
In a guidance document posted May 21, the FDA’s Center for Devices and Radiological Health and Center for Biologics Evaluation and Research said that the agency was providing the policy “to help address current manufacturing limitations or supply chain issues” due to disruptions caused by the emergency and “to help foster the continued availability of medical devices” during the pandemic.
The policy may help device manufacturers address current manufacturing limitations or supply chain issues due to COVID-19-related disruptions, the FDA said, such as the addition of production lines or manufacturing at alternative sites that may have different manufacturing equipment to increase manufacturing capacity and supply or to reduce supply chain interruptions and manufacturing bottlenecks.
Examples of Covered Device Modifications
General examples of the types of modifications covered by the policy include:
- design and manufacturing changes made to address component unavailability due to supply chain disruptions;
- manufacturing changes to allow an establishment to maintain operations and accommodate social distancing practices;
- changes in a manufacturing facility or establishment; and
- changes to packaging procedures.
The FDA provided more detailed examples of circumstances to which the policy applies — i.e., circumstances where the agency believes that a modification that normally would trigger a supplement or 30-day notice submission requirement would generally not create an undue risk in light of the public health emergency and may be needed to address current manufacturing limitations or supply chain issues due to COVID-19-related disruptions.
Specifically, the FDA suggested, the policy would apply, for example, to the following changes that generally require a PMA or HDE supplement:
- component changes due to a component supply interruption as a result of COVID-19, and any necessary software or firmware modifications to accommodate the component changes, when they do not affect the performance of the device; and
- device material changes due to changes in manufacturing methods that do not affect the performance of the device.
Examples of changes that would generally require a PMA or HDE 30-day notice and that come within the policy include:
- supplier changes made to maintain continuity in manufacturing where specifications are unchanged;
- equipment changes to allow for processes to perform in a way that is equivalent to previously approved processes within the same facility;
- changes to accommodate social distancing, such as modifications to manufacturing processes that are made to promote social distancing practices among employees or operators;
- the automation of existing processes that are fully verified;
- the automation of certain processes, such as packaging and labeling processes to accommodate social distancing; and
- the addition of manufacturing lines to increase capacity in existing facilities approved as part of an original PMA or HDE application or a supplement.
An example of a change that generally would require a PMA or HDE site-change supplement and that comes within the policy, the FDA said, is a change in a manufacturing facility or establishment to an alternative site with established good manufacturing practices (i.e., compliance with 21 C.F.R. Part 820) or during the public health emergency, to an alternative ISO 13485-certified site.
Exclusions from the Policy
The agency stressed that the policy does not apply to design or manufacturing changes made for reasons other than addressing manufacturing limitations or supply chain issues resulting from the COVID-19 public health emergency. The policy also does not apply to proposed changes described in regulatory submissions that the FDA has already received.
The agency offered examples of circumstances where the agency currently believes that a modification would create an undue risk and therefore would not come within the policy:
- changes to the intended use of a device, including new indications for use;
- changes to device labeling that are outside of the scope of the recommendations described in other FDA policies for specific devices during the public health emergency;
- changes to a device’s sterility assurance level (SAL) or sterilization method;
- changes made to reduce or eliminate quality control testing;
- the automation of a manufacturing process that is not fully verified; and
- a change that affects the performance of a device but is not caused by the unavailability of a component.
The FDA said that manufacturers must document any changes to their products in device master records and change control records, and the information must be made available to the agency, if required. These records may include applicable standards to which a device conforms, software and firmware verification or validation, functional testing, mechanical testing and temperature testing.
The agency suggests that modifications made under the policy be identified and described in the next period report that is due after the modification is made and in accordance with the PMA or HDE approval order for the product.