Overview
Title
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Humanitarian Use Devices
Agencies
ELI5 AI
The FDA wants to hear what people think about special medical gadgets that help fewer than 8,000 people in the U.S. with rare health problems. They want to make sure these gadgets are safe and can be used more easily by asking people to share their thoughts by March 26, 2021.
Summary AI
The Food and Drug Administration (FDA) is collecting information regarding humanitarian use devices (HUDs), which are medical devices meant for conditions affecting fewer than 8,000 people in the U.S. The FDA seeks public comments on this information collection by March 26, 2021, to help decide whether these devices should be exempt from certain effectiveness requirements. This effort is in accordance with the Paperwork Reduction Act and aims to ensure that those with rare conditions have access to necessary medical devices without significant safety risks. Additionally, the FDA updated estimates of the time and resources needed for this data collection to reflect more current information.
Abstract
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Keywords AI
Sources
AnalysisAI
The document from the Federal Register is a notice by the Food and Drug Administration (FDA) regarding the collection of information on humanitarian use devices (HUDs). These are specialized medical devices intended for conditions that affect fewer than 8,000 individuals in the United States. The FDA has submitted a proposed information collection to the Office of Management and Budget (OMB) as part of its obligations under the Paperwork Reduction Act. The public is invited to provide comments on this collection effort by March 26, 2021.
Significant Issues and Concerns
One primary concern with this document is its reliance on technical language and specific references to sections of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Code of Federal Regulations (CFR). Such details might be daunting for individuals without a legal or regulatory background, potentially hindering their understanding of the notice's implications.
The document also assumes familiarity with FDA-related acronyms and terms such as HUD, HDE (Humanitarian Device Exemption), and OMB control numbers. This assumption might alienate members of the public who do not work in related fields, impeding their ability to provide informed comments.
Another issue is the mention of increased estimated burden hours and the number of respondents, which suggests that more resources may be needed to comply with the information collection process. However, the document provides no explanation for these increases, perhaps leading to concerns about transparency and the necessity for additional resource allocation.
Impact on the Public
Broadly, the document highlights an initiative that could significantly benefit individuals with rare medical conditions by allowing access to crucial devices that may otherwise be unavailable. By exempting certain devices from standard effectiveness requirements, the FDA aims to expedite their availability, which can be life-altering for those impacted.
However, if the complexities and technical jargon are not adequately addressed, there is a risk that the general public might feel excluded from the commenting process, which could lead to a less comprehensive collection of feedback.
Impact on Specific Stakeholders
For patients affected by rare conditions, this process holds the potential for positive outcomes in terms of improved access to necessary devices. Medical device manufacturers may also benefit through opportunities to bring products to market with fewer hurdles, provided they meet safety standards.
Conversely, these stakeholders might encounter challenges if they find the submission processes ambiguous or overly burdensome due to revised requirements and increased reporting obligations.
In summary, while the FDA's initiative to streamline access to humanitarian use devices has promising intentions, its presentation in a more accessible format could enhance public engagement and lead to more effective global health improvements. The document could benefit from clearer explanations of legal references and an expanded discussion of how the collected information will directly benefit public health.
Issues
• The document contains technical references to specific sections of the FD&C Act and CFR without providing an explanation or summary, which could be unclear or difficult for non-expert readers to understand.
• Language used regarding submission requirements and updates, such as in § 814.104(b)(4)(i), could appear complex and may benefit from simplification or additional clarification for better comprehension.
• The increases in estimated burden hours and the number of respondents might imply potential additional resource allocation, but no justification or explanation is provided for these increases, which could be seen as a lack of transparency.
• The document assumes that the reader understands FDA acronyms and terms like HUD, HDE, and OMB control numbers, which might not be clear to all readers.
• The document does not elaborate on how the collected information will be utilized for public benefit, which might lead to concerns about the purpose and efficiency of data collection.