FDA will allow companies to make “limited modifications” to medical devices marketed under premarket approvals and humanitarian device exemptions, according to a guidance issued Thursday, citing the coronavirus public health emergency.
The agency said companies may need to make rapid changes to avoid supply disruptions during the crisis, for example by moving production to a region less affected by the virus.
The guidance removes regulatory barriers to such actions by clearing manufacturers to make certain changes without first filing supplements or 30-day notices. It also lays out changes that would not qualify for the new policy.
The task of manufacturing and shipping medical devices is being complicated by factors including restrictions on in-person contact and disruptions to global supply changes. FDA acknowledges such complicating factors may drive manufacturers to make changes to their devices and operations.
“Numerous manufacturers may need to make immediate changes such as adjusting manufacturing processes to allow for social distancing, adapting their manufacturing or design due to supply chain disruption, or to moving device production to a region that is less impacted by COVID-19,” FDA wrote.
Under normal circumstances, FDA would ask manufacturers to file a supplement to their premarket approvals or humanitarian device exemptions, or submit a 30-day notice, before making such changes to their devices and operations. FDA has deemed some of those steps unnecessary in the current crisis.
The agency is extending the regulatory flexibility to a limited set of modifications made specifically to address “manufacturing limitations or supply chain issues resulting from the COVID-19 public health emergency.” FDA cited changes to address component shortages and comply with social distancing rules as examples of revisions companies can make without first filing supplements.
Companies can even move production to a different facility without filing a site-change supplement. The new site must be certified under ISO 13485, a set of requirements for medical device quality management systems.
Whatever the nature of the changes, FDA expects companies to document them in change control and device master records. The agency is advising companies to identify and describe any changes made without prior notification in the next period report.
FDA is permitting companies to make such changes without prior notification on the grounds that the revisions do not create “an undue risk in light of the public health emergency.” The guidance also features examples of changes that FDA says would create undue risks.
In the document, FDA singled out changes to the sterilization method, reductions in quality control testing and the automation of “a manufacturing process that is not fully verified” as examples of revisions likely to create undue risks. Manufacturers seeking those changes will need to follow established process on post-authorization revisions.
Changes to the device's labeling, intended use and new indications are also listed among those not covered under the new policy.