Lance's Corner

FDA Issues Standards Newsletter

Nov 20, 2024

The United States Food and Drug Administration (FDA) has issued its Standards Newsletter, which can be read below.

Standards Newsletter Banner, from the Center for Devices and Radiological Health, Division of Standards and Conformity Assessment (DSCA)

The word Standards with blue arrows

November 2024

In this Fall edition of the Standards newsletter, learn about the latest resources and opportunities to enhance your use of consensus standards in the design, development, and evaluation of health technologies for medical devices across their lifespans.

Standards News

Submit comments: Updated draft guidance documents 

The FDA has proposed updates to the three Accreditation Scheme for Conformity Assessment (ASCA) guidance documents to reflect lessons learned during the pilot phase of the program. The updates proposed in these draft guidances include, among others:   

  • Transition from a pilot to a permanent program 
  • Biocompatibility scope enhancement, adding five new test methods (including ASCA Summary Test Report examples)  
  • Updates to the Basic Safety and Essential Performance Summary Test Report example 

Submit comments by December 23, 2024 to ensure the FDA considers comments on these drafts before it begins work on the final versions of the guidances.

DSCA on the Move: Connecting and Collaborating

Recent Webinar on Standards Use 

Terry Woods, director of the FDA’s CDRH Division of Standards and Conformity Assessment (DSCA), participated in a webinar on standards use hosted by the Clinical and Laboratory Standards Institute. More than 600 people attended this event, which featured a robust discussion about how best to use consensus standards on in vitro diagnostic submissions.  

FDA-Regulatory Affairs Professionals Society 2024 Roadshow

A woman giving a presentationMany thanks to the Regulatory Affairs Professionals Society (RAPS) for welcoming the FDA’s Gail Rodriguez, PhD, to their San Francisco and Utah chapters in August to talk about all things standards. In addition,the Western Canada RAPS Chapter drew an enthusiastic audience of approximately 100 people for a virtual presentation in September from Jianchao Zeng, PhD., assistant director of DSCA’s Standards Management Program at the FDA.  

 

Need an FDA Standards Speaker? 

Would your company or organization like a representative from the FDA to speak about standards and their appropriate use in device submissions? We welcome the opportunity to discuss the ASCA program and how to use consensus standards. Contact us today at CDRHStandardsStaff@FDA.HHS.GOV to learn more!

Recognition Decisions 

Recent Additions to the Recognized Consensus Standards Database 

The FDA added the following standards to the Recognized Consensus Standards database: 

  • ISO 11737-3:2023 Sterilization of health care products - Microbiological methods - Part 3: Bacterial endotoxin testing
  • ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements
  • ISO 13004:2022 Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD

These recognition decisions will appear in the Federal Register, but manufacturers may cite them now. If you would like to recommend a standard for FDA recognition, email CDRHStandardsStaff@fda.hhs.gov.  
Consult the Recognition and Withdrawal of Voluntary Consensus Standards guidance for details about the recognition program and what should be included in a recognition request. 

Did you know? Tips for FDA device submissions

While using standards in device submissions is voluntary, the FDA strongly recommends that manufacturers cite FDA-recognized consensus standards whenever possible. The use of FDA-recognized consensus standards can increase predictability, streamline premarket review, provide clearer regulatory expectations, and facilitate market entry for safe and effective medical products, while promoting international harmonization. As stated in the Appropriate Use of Voluntary Consensus Standards (ASCA) guidance and on DSCA’s web page.

  • Submitting a declaration of conformity to an FDA-recognized standard generally decreases the amount of supporting documentation needed. For example, when you rely upon a recognized consensus standard, a complete test report may not be necessary to further support the marketing application, reducing the time the FDA needs to assess conformity. 
  • At a high level, supporting documentation may be necessary to supplement the consensus standard when it does not include sufficient detail to address safety and/or performance aspects of the device. For example, if the consensus standard features a choice of methods, you should indicate in supporting documentation what method was chosen and why it was appropriate for that device. Similarly, if the consensus standard does not include acceptance criteria, you should state the criteria along with a rationale. 

Consider participating in the voluntary ASCA program, where standards included in ASCA require only that you submit a declaration of conformity and an ASCA Summary Test Report. Learn more on the ASCA webpage.

Events 

Public workshop held: Accreditation Scheme for Conformity Assessment and Use of Chemical Analysis to Support Biocompatibility of Medical Devices 

On November 6, 2024, the FDA held a public workshop to discuss the possible expansion of the Accreditation Scheme for Conformity Assessment (ASCA) program to include chemical analysis to support biocompatibility of medical devices. Visit the workshop’s web page for more information. 

Save the date: Medical Device Sterilization Town Hall  

During the town hall on November 20, 2024, we will discuss new additions to the Recognized Consensus Standards database related to sterilization. Learn more about sterilization for medical devices.

Contact Us 

The Division of Standards and Conformity Assessment (DSCA) seeks to promote patient safety, advance regulatory science, and support a least burdensome regulatory framework. We value your feedback. Please send us your comments, questions, and ideas for future editions of the Standards Newsletter by e-mailing DSCA at CDRHStandardsStaff@fda.hhs.gov.  Visit our web page on FDA.gov to learn more about how you can use consensus standards in your premarket submissions, the standards recognition process, and more.

USDOL Issues Comprehensive Employer Guidance on Long COVID

The United States Department of Labor (USDOL) has issued a comprehensive set of resources that can be accessed below for employers on dealing with Long COVID.

Supporting Employees with Long COVID: A Guide for Employers

The “Supporting Employees with Long COVID” guide from the USDOL-funded Employer Assistance and Resource Network on Disability Inclusion (EARN) and Job Accommodation Network (JAN) addresses the basics of Long COVID, including its intersection with mental health, and common workplace supports for different symptoms.  It also explores employers’ responsibilities to provide reasonable accommodations and answers frequently asked questions about Long COVID and employment, including inquiries related to telework and leave.

Download the guide

Accommodation and Compliance: Long COVID

The Long COVID Accommodation and Compliance webpage from the USDOL-funded Job Accommodation Network (JAN) helps employers and employees understand strategies for supporting workers with Long COVID.  Topics include Long COVID in the context of disability under the Americans with Disabilities Act (ADA), specific accommodation ideas based on limitations or work-related functions, common situations and solutions, and questions to consider when identifying effective accommodations for employees with Long COVID.  Find this and other Long COVID resources from JAN, below:

Long COVID, Disability and Underserved Communities: Recommendations for Employers

The research-to-practice brief “Long COVID, Disability and Underserved Communities” synthesizes an extensive review of documents, literature and data sources, conducted by the USDOL-funded Employer Assistance and Resource Network on Disability Inclusion (EARN) on the impact of Long COVID on employment, with a focus on demographic differences.  It also outlines recommended actions organizations can take to create a supportive and inclusive workplace culture for people with Long COVID, especially those with disabilities who belong to other historically underserved groups.

Read the brief

Long COVID and Disability Accommodations in the Workplace

The policy brief “Long COVID and Disability Accommodations in the Workplace” explores Long COVID’s impact on the workforce and provides examples of policy actions different states are taking to help affected people remain at work or return when ready.  It was developed by the National Conference of State Legislatures (NCSL) as part of its involvement in USDOL’s State Exchange on Employment and Disability (SEED) initiative.

Download the policy brief

Understanding and Addressing the Workplace Challenges Related to Long COVID

The report “Understanding and Addressing the Workplace Challenges Related to Long COVID” summarizes key themes and takeaways from an ePolicyWorks national online dialogue through which members of the public were invited to share their experiences and insights regarding workplace challenges posed by Long COVID.  The dialogue took place during summer 2022 and was hosted by USDOL and its agencies in collaboration with the Centers for Disease Control and Prevention and the U.S. Surgeon General.

Download the report

Working with Long COVID

The USDOL-published “Working with Long COVID” fact sheet shares strategies for supporting workers with Long COVID, including accommodations for common symptoms and resources for further guidance and assistance with specific situations.

Download the fact sheet

COVID-19: Long-Term Symptoms

This USDOL motion graphic informs workers with Long COVID that they may be entitled to temporary or long-term supports to help them stay on the job or return to work when ready, and shares where they can find related assistance.

Watch the motion graphic

A Personal Story of Long COVID and Disability Disclosure

In the podcast “A Personal Story of Long COVID and Disability Disclosure,” Pam Bingham, senior program manager for Intuit’s Diversity, Equity and Inclusion in Tech team, shares her personal experience of navigating Long COVID symptoms at work.  The segment was produced by the USDOL-funded Partnership on Employment and Accessible Technology (PEAT) as part of its ongoing “Future of Work” podcast series.

Listen to the podcast

HHS OIG Issues Annual Report on State MFCUs

Per the notice below, the Office of the Inspector General (OIG) of the United States Department of Health and Human Services (HHS) has issued its annual report on the performance of state Medicaid Fraud Control Units (MFCUs).

Medicaid Fraud Control Units Fiscal Year 2023 Annual Report (OEI-09-24-00200) 

Medicaid Fraud Control Units (MFCUs) investigate and prosecute Medicaid provider fraud and patient abuse or neglect. OIG is the Federal agency that oversees and annually approves federal funding for MFCUs through a recertification process. This new report analyzed the statistical data on annual case outcomes—such as convictions, civil settlements and judgments, and recoveries—that the 53 MFCUs submitted for Fiscal Year 2023.  New York data is as follows:

Outcomes

  • Investigations1 - 556
  • Indicted/Charged - 9
  • Convictions - 8
  • Civil Settlements/Judgments - 28
  • Recoveries2 - $73,204,518

Resources

  • MFCU Expenditures3 - $55,964,293
  • Staff on Board4 - 257

1Investigations are defined as the total number of open investigations at the end of the fiscal year.

2Recoveries are defined as the amount of money that defendants are required to pay as a result of a settlement, judgment, or prefiling settlement in criminal and civil cases and may not reflect actual collections.  Recoveries may involve cases that include participation by other Federal and State agencies.

3MFCU and Medicaid Expenditures include both State and Federal expenditures.

4Staff on Board is defined as the total number of staff employed by the Unit at the end of the fiscal year.

Read the Full Report

View the Statistical Chart

Engage with the Interactive Map

GAO Issues Report on Medicaid Managed Care Service Denials and Appeal Outcomes

The United States Government Accountability Office (GAO) has issued a report on federal use of state data on Medicaid managed care service denials and appeal outcomes.  GAO found that federal oversight is limited because it doesn't require states to report on Medicaid managed care service denials or appeal outcomes and there has not been much progress on plans to analyze and make the data publicly available.  To read the GAO report on federal use of state data on Medicaid managed care service denials and appeal outcomes, use the first link below.  To read GAO highlights of the report on federal use of state data on Medicaid managed care service denials and appeal outcomes, use the second link below.
https://www.gao.gov/assets/d24106627.pdf  (GAO report on federal use of state data on Medicaid managed care service denials and appeal outcomes)
https://www.gao.gov/assets/d24106627_high.pdf  (GAO highlights on federal use of state data on Medicaid managed care service denials and appeal outcomes)

CMS Issues Latest Medicare Regulatory Activities Update

The Centers for Medicare and Medicaid Services (CMS) has issued its latest update on its regulatory activities in the Medicare program.  While dentistry is only minimally connected to the Medicare program, Medicare drives the majority of health care policies and insurance reimbursement policies throughout the country.  Therefore, it always pays to keep a close eye on what CMS is doing in Medicare.  To read the latest CMS update on its regulatory activities in Medicare, use the link below.
https://www.cms.gov/training-education/medicare-learning-network/newsletter/2024-03-14-mlnc