The U.S. FDA disclosed the device user fee schedule for fiscal 2021, which calls for a total revenue amount of nearly $212 million, an amount that adjusts for inflation for both employee salaries and the overall Consumer Price Index for the metropolitan Washington area. Fees for PMA filings will be roughly $366,000, unless the entity qualifies as a small business ($100 million or less in annual revenues), in which case PMA fees will be $91,000. De novo petitions will require a fee of about $110,000 ($27,000 for small businesses) while 510(k) filings will demand fees of $12,000 ($3,100 for small businesses). Facility registration fees will be $5,546 for all manufacturing sites, and the FDA said companies with revenues of $30 million or less may be eligible for a waiver of the PMA fees so long as the related documentation is on file at the agency at least 60 days prior to submission.
The International Organization for Standardization (ISO) unveiled July 30 an update to the organization’s standard for medical device clinical trials. ISO had planned to release the updated edition of ISO 14155, but was forced to delay the release. It turned out to be a delay of only two months, however. ISO said 14155 has been adjusted “to align with recent regulatory changes and amendments to other relevant standards,” along with additional information to protect clinical study participants. Danielle Giroud, who chaired the working group that handled the revision, said that the changes align with the European Medical Device Regulations and the FDA’s requirements, adding that the new edition provides more detail regarding matters such as informed consent and vulnerable populations. In the aggregate the changes “result in safer clinical investigation with more solid evidence,” Giroud said.
The U.S. Government Accountability Office said federal agencies had awarded nearly $18 billion in contracts related to the COVID-19 pandemic as of mid-June. Of note, 85% of those were awarded by three entities, including the Department of Health and Human Services (HHS). Roughly $11 billion of that amount was allocated for personal protective equipment, more than $9 billion of which was awarded without competition. The urgency of the need to respond to the pandemic was most often the reason given for no-compete awards, and HHS awarded approximately $3.5 billion for medical and surgical equipment, along with another $1 billion for hospital surgical clothing. Laboratory equipment and supplies accounted for less than $1 billion.