FDA device center guidance priority lists targets COVID, digital health

Regulatory NewsRegulatory News | 18 October 2022 |  By 

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has published its FY2023 guidance priority lists. Much of the center’s focus in the current fiscal year is on transitioning COVID-19 devices and diagnostics from emergency use authorizations (EUAs) to traditional marketing authorizations and addressing issues around digital health.
 
On 17 October, CDRH published its annual priority A and B lists of guidances that it wants to develop in FY2023, as well as a list of past guidances it wants to review and possibly update. The items on the A list are guidances that FDA will prioritize to complete before the end of FY2023, while the ones on the B list are guidances it will try to complete in the same time frame, depending on available resources.
 
On its A list, FDA includes two final guidances that address how products under its COVID-19 enforcement policies and those with EUAs can transition to traditional marketing pathways once the current public health emergency (PHE) ends. The topic is something industry has eagerly awaited to hear about as many manufacturers currently have COVID-19-specific products they would like to keep on the market after the PHE is lifted.
 
FDA also said it will publish several digital health guidances, including one for medical device cybersecurity quality system considerations, one for device software functions and another addressing change control plans for products with artificial intelligence/machine learning software.
 
Over the years the agency has repeatedly updated its premarket and postmarket cybersecurity guidances to stay up to date, and more recently the issue of change control plans has become an important topic for regulators and industry.
Some lawmakers unsuccessfully tried to include a rider in the latest user fee reauthorization bill giving FDA explicit authority to allow change control plans, which the medical device industry says it is one of its legislative priorities when Congress passes an omnibus budget bill later this year. However, the agency has in the past also made the argument it already has the authority to allow change control plans in a white paper, and some legal experts support the agency’s assessment. (RELATED: AdvaMed seeks diagnostics reform in December budget bill, Regulatory Focus 13 October 2022; FDA should step in to help spur AI/ML standards: Expert, Regulatory Focus 13 June 2022)
 
FDA is also planning to publish multiple guidances addressing its Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program meant to encourage sponsors to adopt recognized standards in product development, and other important topics such as the agency breakthrough devices program and what constitutes remanufacturing of a device.
 
Following is a table of the guidances FDA plans to publish in FY2023:
 
A-List: Prioritized Guidance Documents that CDRH Intends to Publish in FY2023
Final Guidance Topics
Remanufacturing of Medical Devices
Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
Content of Premarket Submissions for Device Software Functions
Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program
Breakthrough Devices Program (revised)
Draft Guidance Topics
Voluntary Malfunction Summary Reporting (VMSR) Medical Device Reporting (MDR) for Manufacturers
Clinical Considerations for Medical Device Premarket Submissions Targeting Opioid Use Disorder
Select Updates for Guidance for the Breakthrough Devices Program
Electronic Submission Template for De Novo Request Submissions
B-List: Guidance Documents that CDRH Intends to Publish, as Guidance Development Resources Permit in FY2022
Final Guidance Topics
Peroxide-Based Contact Lens Care Products – Patient Labeling Recommendations 
Draft Guidance Topics
Chemical Analysis for Biocompatibility Assessment of Medical Devices
Marketing Submission Recommendations for A Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions
Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies (revision of Evaluation of Sex-Specific Data in Medical Device Clinical Studies)
The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
Biocompatibility Testing of Medical Devices – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
 
FDA also included a list of past final guidances it plans to review and consider updating. The list includes guidances from as far back as 1983, and looks at several product-specific 510(k) guidances, guidances on conducting clinical trials, and more.

 

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