- FDA's Center for Devices and Radiological Health annual list of guidance documents it aims to publish in the upcoming fiscal year sets priorities for five final documents and 12 draft releases.
- Final guidance on surgical staplers, the Safer Technologies Program, clinical decision support software and product labeling for laparoscopic power morcellators made CDRH's 'A list'. The fifth goal on that list involves device-specific criteria guidance for implementing the Safety and Performance Based Pathway.
- The draft guidance agenda for 2021 includes postmarket surveillance studies, remanufacturing of medical devices, device shortages, and a transition plan for devices distributed under enforcement policies or emergency use authorization during the coronavirus pandemic.
The COVID-19 public health emergency has prompted a shift in FDA resources and seems to have contributed to a delay in some guidance release timelines. Items carried over from last year's list to be finalized include the Safer Technologies Program for Medical Devices, surgical staplers and clinical decision support software.
At the start of the pandemic, FDA Commissioner Stephen Hahn said CDRH staff were being pulled into COVID-19 work on emergency use authorizations and related guidance documents.
The Safer Technologies Program for Medical Devices is a new voluntary initiative for devices expected to significantly improve the safety of current treatments or diagnostics for conditions less serious than those addressed under the breakthrough devices program. FDA issued a draft guidance introducing the proposed program in September 2019.
Errors involving use of surgical staplers led FDA last year to issue a proposed rule to reclassify the devices from Class I to the higher-risk Class II category. An advisory panel for the agency supported the plan.
Clinical decision support software is described in a September 2019 draft guidance as giving healthcare professionals and patients person-specific information to improve care. The software can include tools such as computerized alerts and reminders, clinical guidelines, order sets for conditions, focused data reports and diagnostic support. FDA proposed the guidance to explain its approach to regulating those functions.
FDA in February advised in a safety communication that laparoscopic power morcellators should be used only with a tissue containment system due to the risk that the treatment may spread previously undetected cancer. The agency also recommended in a draft guidance that product labels for the devices, which are used in uterine fibroid removal and hysterectomy procedures, contain a boxed warning with information on the risk of spreading malignant tissue.
In addition to its plans for finalizing guidance documents in 2021, the agency also outlined a number of draft guidances it intends to produce. Additional topics listed there include computer software assurance, remanufacturing of devices, Case for Quality Voluntary Improvement Program, cybersecurity management, unique device identification, medical device shortages, and premarket submissions for software.