The US Food and Drug Administration (FDA) has published a final guidance that extends its pandemic-era policy of allowing manufacturers to make certain modifications to products that are on the market under a premarket approval (PMA) or humanitarian device exemption (HDE). The move is meant to alleviate supply chain disruptions and device shortages.
In May 2020, FDA published guidance that it has since updated several times to ensure medical devices on the market under PMA and HDE are able to be modified quickly and brought to patients without the need to submit a supplementary product application or 30-day notice. While the policy was supposed to end with the expiration of the COVID-19 public health emergency (PHE), the agency said it will continue to allow flexibility due to current concerns about supply chain disruptions…
