Regulatory

MDR’s Day One: Experts weigh in

Every medical device manufacturer, importer, and distributor who wants to continue marketing their product into the EU or initiate business in the EU after 26 May 2021 will be responsible for MDR compliance. This is a significant change for many different organizations around the world. The rigor required by EU notified bodies will affect the time and resources companies need to become MDR compliant based on the risk of the device. Experts say key worries include the fact that only a limited fraction of current products on the EU market are actually being assessed for MDR at this stage, as conformity assessment applications to the 20 notified bodies that are currently designated are quite low in numbers; and that the wave of MDR applications coming in 2023 and 2024, when MDD certificates grandfathered under the grace period must transition, will be insurmountable.

(RAPS 5/26/21)

EU MDR Date of Application roundup: EMDN, eIFUs, UDI helpdesk, clinical investigation

This article covers documents and other support services recently released by the European Commission (EC) to equip medical device manufacturers for MDR compliance.

(Emergo 5/26/21)

FDA clarifies potential actions when onsite inspections are infeasible

FDA announced that while the pandemic continues to restrict onsite inspections, the agency “intends to continue using alternative tools to evaluate facilities.” FDA continues to conduct onsite inspections for those products deemed “mission critical.” The Q&A addresses how inspections have been impacted by COVID-19, the types of inspections FDA deems “mission critical,” and its criteria for issuing complete response (CR) letters following an inspection.The new updates to the guidance document clarify which actions FDA may take when it cannot conduct a physical inspection.

(RAPS 5/18/21)

FDA finalizes brain-computer interface guidance

The first final guidance from FDA’s CDRH provides device developers with clinical and non-clinical testing considerations for implanted brain-computer interface (BCI) devices intended for use by patients with paralysis or amputation. The 30-page guidance document takes developers through considerations in the pre-submission and investigational device exemption processes, with special attention given to non-clinical bench testing considerations. An appendix provides stimulation output specifications. The guidance strongly encourages developers to avail themselves of feedback from FDA early in the BCI development process through the agency’s Q-submission program.

(RAPS 5/20/21)

FDA issues new draft guidances on device postmarket surveillance

FDA has issued two draft guidances to help device manufacturers comply with postmarket surveillance requirements and to understand the agency’s expectations for post-approval studies (PASs). The guidances have been revised to require new reporting on patient enrollment. The first guidance spells out procedures for handling PASs imposed as a condition of premarket approval (PMA), while the second addresses FDA’s interpretation of postmarket surveillance orders under section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) with respect to certain class II or class III medical devices

(RAPS 5/28/21)

Shuren updates on inspections, ISO 13485 and MDUFA V 

FDA’s proposed rule to harmonize its medical device Quality System Regulation (QSR) with the international standard, ISO 13485:2016, may finally see the light of day this year, Jeff Shuren, director of CDRH said at the FDA/Xavier MedCon conference. While the pandemic has had a dramatic impact on the agency’s ability to conduct inspections, Shuren said that it has compensated by leveraging the Medical Device Single Audit Program (MDSAP) and more recently by conducting voluntary remote regulatory assessments. With the agency in the midst of negotiations to reauthorize the Medical Device User Fee Amendments (MDUFA), Shuren said the pandemic is continuing to impact review performance.

RAPS- 10^th May 2021

FDA pushes back deadline for removal of legacy identifiers to 2023 

After receiving pushback from industry, the US FDA said it will give medical device makers two more years to remove legacy identification numbers from their product labels and packages. Under FDA’s 2013 unique device identification (UDI) final rule, medical device labels and packages are required to bear a UDI according to the schedule set in the final rule, with some exceptions and alternatives for certain devices. The UDI Rule also includes a provision to rescind National Health Related Item Code (NHRIC) and National Drug Code (NDC) numbers assigned to devices once UDI provisions are applicable to them.

RAPS- 20^th May 2021

Payment

MCIT is now delayed until December 

The MCIT rule, which provides Medicaid coverage for breakthrough medical devices, was initially passed in January but implementation was delayed until April during the administration changeover. This month it was announced that the rule would be further delayed amid CMS’ concerns over shortcomings including the lack of requirement of evidence that the breakthrough devices would be specifically beneficial to the Medicare population. The delay is a disappointment for the med tech industry, but some theorize that a revised version of MCIT could be included in the renewal of the 21^st Century Cures Act in 2022.

(MedTechDive, 5/17/22)

Senate confirms new CMS Administrator 

Chiquita Brooks-LaSure has been confirmed as the next administrator of the Centers for Medicare & Medicaid Services (CMS). The position of CMS administrator is one of the most important healthcare jobs in the country and controls an annual budget of over $1 trillion.  Brooks-LaSure played a key role in the passage of the Affordable Care Act under the Obama administration. She is the first Black woman to lead CMS in its six-decade-long history.

(Home Health Care News, 5/25/21)

CMS inpatient rule keeps hospital payments ‘as steady as possible’ 

The inpatient rule repealed the cost reporting requirement that had been mandated by a controversial 2019 rule.  This repeal means that hospitals do not need to begin cost data at the end of the year. Instead, CMS will use 2019 data to set the 2022 rates. The thinking is that this data will be more accurate because of the impact of the pandemic on healthcare utilization. Another significant impact of the rule is the extension of the New Technology Add-On Payments that were due to have expired at the end of year.

(Healthcare Finance, 5/6/21)

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 Amaris Ajamil, PhD, RAC, Simbex Senior Quality Assurance/Regulatory Engineer, 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.