Overview
Title
Agency Information Collection Activities; Proposed Collection; Comment Request; Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices
Agencies
ELI5 AI
The FDA wants to hear people's thoughts on a plan to make sure that single-use medical gadgets have clear labels showing who made them, so nobody gets confused. They are also interested in knowing if people think collecting this information is important or if there are better ways to do it.
Summary AI
The Food and Drug Administration (FDA) is asking for public feedback on gathering certain data about reprocessed, single-use medical devices under the Paperwork Reduction Act. This public comment period lasts for 60 days, ending on April 26, 2021. The FDA wants to know if the information collection is necessary, how accurate their burden estimates are, and if there are better ways to collect data. This initiative aims to ensure that reprocessed devices clearly show the manufacturer's name or symbol to prevent misbranding, as required by federal law.
Abstract
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on reprocessed, single-use device labeling.
Keywords AI
Sources
AnalysisAI
The document from the Food and Drug Administration (FDA) announces their initiative to gather public feedback related to the labeling of reprocessed, single-use medical devices. This activity is underpinned by the Paperwork Reduction Act, which requires federal agencies to seek public input when collecting information. This particular call for comments aims to improve the way these medical devices display their manufacturer’s name or symbol as part of broader efforts to prevent misbranding.
Overview
The FDA is focused on improving the labeling of single-use devices that have been reprocessed for safe reuse. By ensuring that these devices conspicuously display their manufacturer's details, the FDA seeks to maintain transparency and trust in medical device usage. Public comments are invited to ascertain whether the process of information collection is crucial to the FDA’s responsibilities, verify the estimations of related workloads, and explore ways to streamline the data collection process.
Significant Issues and Concerns
Confidential Information Submission: The document addresses how individuals can submit comments with confidential information. However, the explanation appears complex, particularly around the submission of confidential documents in duplicate, which could be simplified for better public understanding.
Complex Instructions: The document's instructions on how to submit written comments could benefit from clearer, step-by-step guidance. This would help commenters navigate the process without unnecessary confusion.
Clarity of Burden Estimates: There is a mention of an increase in the burden of information collection by 52 hours, but it lacks context since there's no previous burden figure given. This omission may leave readers unclear about the implications of this change.
Knowledge Assumptions: The document references multiple acts and sections, such as the FD&C Act and MDUFSA, without providing background information. Those not familiar with these legal frameworks might find it difficult to fully understand the context and significance of the requirements.
Public and Stakeholder Impact
Broadly, this document reflects the FDA’s ongoing efforts to safeguard public health by improving the traceability and accountability of medical devices through effective labeling. For the general public, this could enhance the reliability and safety of reprocessed medical devices.
For Manufacturers: Requirements to update labeling could involve additional steps and potentially increased costs, especially for smaller businesses with fewer resources. While the document estimates a minimal burden on these entities, the absence of detailed cost or resource implications might not wholly capture the challenges faced by smaller manufacturers.
Positive Outcomes: If implemented effectively, clearer labeling could improve healthcare providers' confidence in using reprocessed devices. Transparency in manufacturer identification helps uphold quality standards and reduces the chances of misbranding, which is critical for patient safety.
In summary, while the FDA’s proposal aims to enhance device labeling and prevent misbranding, thoughtful consideration of feedback, simplification of submission processes, and addressing small business concerns would be necessary to ensure a balanced outcome.
Issues
• The language related to the submission of confidential information could be clearer, particularly around the process of submitting two copies and how the confidentiality is maintained.
• The instructions for submitting written submissions contain multiple steps which may be confusing for some users. A more step-by-step format might be easier to follow.
• The section on the estimated burden of the collection of information refers to 'an increase of 52 hours' without specifying the previous burden for comparison, which could be unclear to the reader.
• The document assumes the reader has prior knowledge of various acts (e.g., FD&C Act, MDUFSA) and their sections, which might be unclear for individuals unfamiliar with these references.
• The method for calculating the burden of collection (i.e., estimated time per response and total establishments) is not fully explained, which could lead to confusion about the methodology used.
• There is no mention of potential impacts or considerations for smaller businesses, which may face a relatively higher burden compared to larger establishments.