FDA Issues Draft Guidance For Device Software In Premarket Submissions

 In Blog, News, Regulatory & Reimbursement Update


FDA issues draft guidance for device software in premarket submissions

The US Food and Drug Administration (FDA) has released draft guidance for sponsors outlining its thinking about the documentation needed to support the agency’s evaluation of device software functions for premarket submissions. The agency said the guidance recognizes the “rapidly evolving nature of digital health and recent FDA recognized consensus standards related to software” and, when finalized, will serve as an update to the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices document released in May 2005. Changes made to section 520 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) under the 21st Century Cures Act in December 2016 exclude some types of software, such as lower-risk decision support software like certain mobile apps for consumers and software for administrative support of laboratories

(RAPS: 04 Nov 2021)

FDA says it far exceeded its projections for inspections in FY2021

In an update to its Resiliency Roadmap for FDA Inspectional Oversight, the US Food and Drug Administration (FDA) said that the number of domestic surveillance inspections it carried out in the second half of FY2021 was more than double the number it initially projected in the roadmap last spring. In its initial Roadmap, FDA estimated that more than 15,000 domestic surveillance inspections that it planned to complete in FY2020 and FY2021 were postponed due to the pandemic, and that about 14% of those inspections could be conducted under a best-case scenario with a gradual transition to normal operations. In its initial Roadmap, FDA estimated that more than 15,000 domestic surveillance inspections that it planned to complete in FY2020 and FY2021 were postponed due to the pandemic, and that about 14% of those inspections could be conducted under a best-case scenario with a gradual transition to normal operations.

(RAPS: 22 Nov 2021)

FDA updates eSTAR ahead of expanding filing template for De Novo submissions

FDA has shared additional instructions and clarifications about the eSTAR process for 510(k) filing as part of an update to its advice on premarket submissions. The two updated eSTAR templates for in vitro diagnostics and other medical devices feature minor changes to the older texts for 510(k) filings, enabling medtech companies to continue to use the previous versions for any submissions that are already at the draft stage. FDA used the update to expand eSTAR to De Novo medical device and IVD applications. The agency will start accepting De Novo eSTAR applications when a final rule takes effect at the start of next year.

(MedTechDive: Nov 30, 2021)

FDA’s 2022 A-list guidance plan hits on software, post-pandemic future

FDA has released its list of proposed draft and final medical device guidance documents for fiscal year 2022. The list is heavy on documents related to software, including the long-gestating guidance on clinical decision support (CDS) software. Four of FDA’s high-priority draft and final guidance documents address software, including one planned for publication on software premarket submission that FDA failed to post in time to meet its MDUFA IV commitments. FDA also plans to publish two draft documents setting out transition plans for medical devices covered by COVID-19 enforcement policies or emergency use authorizations. Test developers will need to get diagnostics authorized using traditional premarket review processes to support post-pandemic use.

(MedTechDive: 1 Nov 2021)


CMS adds Remote Therapeutic Monitoring to 2022 Physician Fee Schedule 

The Centers for Medicare and Medicaid Services (CMS) added five new codes for Remote Therapeutic Monitoring in the newly released 2022 Physician Fee Schedule. The codes parallel the existing Remote Physiologic Monitoring pathway and will allow for management of patients in therapy through the use of medical devices to track indications such as adherence, therapeutic response, and pain levels. Targeted specifically to patients with respiratory and musculoskeletal conditions, the CPT codes 98975-98981 are billed as general medical services and are available for use by healthcare professionals including physical therapists, occupational therapists, speech-language pathologists.

(Foley 11/11/21)

AdvaMed expresses disappointment at final repeal of MCIT 

In early November, The Centers for Medicare and Medicaid Services (CMS) announced the final repeal of MCIT – the Trump-era rule that would have allowed automatic reimbursement for FDA-designated Breakthrough devices. AdvaMed released a statement expressing disappointment that the “truly transformational” rule will not be enacted. The medical device advocacy organization added that they are “committed to working with CMS and lawmakers on both sides of the aisle to find a way forward to achieve our mutually shared goal of improving access to new innovations in medical technology for patients.”

(AdvaMed 11/12/21)

Supply chain issues lead to durable medical equipment shortages and price increases 

Medical device shipments are experiencing logistical difficulties as the global supply chain suffers from pandemic-related disruptions. This effect was initially seen in emergency medical supplies, such as ventilators and PPE but has since spread to medical equipment used at home including wheelchairs, walkers, and crutches. The shortages have caused some patients to resort to sterilizing and reusing supplies that should be replaced, such as catheters and tracheotomy tubes, increasing risk of complications and infections.

(Cal Matters 11/22/21)

Inspire Sleep Apnea implant receives CMS payment rate 

Inspire Medial Systems announced that the Centers for Medicare and Medicaid Services (CMS) has included final payment rates in the 2022 ambulatory surgery payment update. The device had already been assigned CPT code 64582, which now has a national average ASC reimbursement rate of $24,828. This rate will be effective as of 1/1/22. This update is in contrast to the initial rate which had initially been quoted at $17,000.

(MassDevice 11/12/21)

Home dialysis system receives Medicare payment adjustment 

Outset Medical announced that The Centers for Medicare and Medicaid Services (CMS) approved a transitional add-on payment adjustment for the Tablo home dialysis system. This approval is expected to encourage healthcare providers to view home dialysis as a viable option. Supplemental reimbursement will be available for the next two years. The Tablo system has a system that allows data to be sent to physicians, supporting remote monitoring and two-way communication between the physician and patients.

(Mass Device 11/1/21)

The Simbex Regulatory and Reimbursement Recap is a monthly briefing for news in the regulatory and healthcare reimbursement space relevant to Simbex areas of expertise. The briefing is curated by Angela Smalley, PhD, Simbex Centers Project Leader, Project Evaluation, and Mohammed Kazi, MS, Simbex Quality Systems Coordinator.  A story’s inclusion does not imply endorsement by Simbex.

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