Posted 19 October 2020 | By
Surgical staplers and laparoscopic power morcellators are among devices that made the grade for the US Food and Drug Administration’s (FDA’s) slate of final guidance topics for fiscal year 2021. The agency also plans to draft a transition plan for devices that have received emergency use authorizations (EUAs) during the pandemic.
The Center for Devices and Radiological Health (CDRH) at FDA released the list of draft and final guidance documents it plans to issue in fiscal year (FY) 2021 on 16 October, prioritizing its plans into an “A-list” of guidances it plans to publish and a “B-list” of documents it intends to publish “as resources permit” through the fiscal year.
In addition to guidances on surgical staplers and product labeling for laparoscopic power morcellators, other device guidance topics that made the A-list to finalize in FY 2021 include the Safer Technologies Program for medical devices, a voluntary program to improve the safety of some currently available device or device-led combination treatments or diagnostic products.
CDRH also anticipates finalizing guidance documents on clinical decision support software and device-specifics guidances for safety and performance-based pathway implementation.
Among the dozen topics to be covered in CDRH’s A-list draft guidances are postmarket surveillance under section 522 of the Federal Food, Drug & Cosmetic Act (FD&C), unique device identification enforcement policies for certain Class I devices, and how to handle post-approval studies that were imposed by premarket approval application orders.
The agency also plans to tackle premarket submissions for software contained in medical devices in FY 2021; device manufacturers will also receive guidance on premarket submissions for management of medical device cybersecurity. An electronic submission template for 510(k) submissions is also slated to be covered in a draft guidance.
As the pandemic continues, CDRH will issue a draft guidance on how Section 506J of the FD&C Act will be implemented to address medical device shortages. Anticipating that the public health emergency of the pandemic will eventually end, the agency will issue a draft guidance detailing a transition plan for devices that received EUAs during the pandemic and have been distributed.
As for the B-list, FDA hopes to finalize guidance on the form and content of the unique device identifier. Also on the wish list for final guidances are those addressing labeling and testing devices for safety in magnetic resonance imagiing environments, brain-computer interface guidance and a guidance addressing replacement reagents for in vitro diagnostic devices. Finally, FDA plans to finalize guidance about patient engagement in medical device clinical investigations.
Draft guidance topics that CDRH will address if resources allow include a risk characterization guidance for software as a medical device, premarket submission considerations for artificial intelligence and machine learning software, and patient labeling for peroxide-based contact lens care products.
The agency also hopes to draft and issue guidances that will identify the highest priority devices for human factors review and the clinical considerations manufacturers should include for premarket submissions that target opioid use disorder.
FDA
The Center for Devices and Radiological Health (CDRH) at FDA released the list of draft and final guidance documents it plans to issue in fiscal year (FY) 2021 on 16 October, prioritizing its plans into an “A-list” of guidances it plans to publish and a “B-list” of documents it intends to publish “as resources permit” through the fiscal year.
In addition to guidances on surgical staplers and product labeling for laparoscopic power morcellators, other device guidance topics that made the A-list to finalize in FY 2021 include the Safer Technologies Program for medical devices, a voluntary program to improve the safety of some currently available device or device-led combination treatments or diagnostic products.
CDRH also anticipates finalizing guidance documents on clinical decision support software and device-specifics guidances for safety and performance-based pathway implementation.
Among the dozen topics to be covered in CDRH’s A-list draft guidances are postmarket surveillance under section 522 of the Federal Food, Drug & Cosmetic Act (FD&C), unique device identification enforcement policies for certain Class I devices, and how to handle post-approval studies that were imposed by premarket approval application orders.
The agency also plans to tackle premarket submissions for software contained in medical devices in FY 2021; device manufacturers will also receive guidance on premarket submissions for management of medical device cybersecurity. An electronic submission template for 510(k) submissions is also slated to be covered in a draft guidance.
As the pandemic continues, CDRH will issue a draft guidance on how Section 506J of the FD&C Act will be implemented to address medical device shortages. Anticipating that the public health emergency of the pandemic will eventually end, the agency will issue a draft guidance detailing a transition plan for devices that received EUAs during the pandemic and have been distributed.
As for the B-list, FDA hopes to finalize guidance on the form and content of the unique device identifier. Also on the wish list for final guidances are those addressing labeling and testing devices for safety in magnetic resonance imagiing environments, brain-computer interface guidance and a guidance addressing replacement reagents for in vitro diagnostic devices. Finally, FDA plans to finalize guidance about patient engagement in medical device clinical investigations.
Draft guidance topics that CDRH will address if resources allow include a risk characterization guidance for software as a medical device, premarket submission considerations for artificial intelligence and machine learning software, and patient labeling for peroxide-based contact lens care products.
The agency also hopes to draft and issue guidances that will identify the highest priority devices for human factors review and the clinical considerations manufacturers should include for premarket submissions that target opioid use disorder.
FDA
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CDRH FY 2021 guidance slate includes post-EUA transition plan - Regulatory Focus
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