Overview
Title
Agency Information Collection Activities; Proposed Collection; Comment Request; 513(g) Request for Information
Agencies
ELI5 AI
The FDA wants to know what people think about some new rules they are making for anyone who wants to ask them about their gadgets and how they should be classified. People can tell the FDA what they think by sending comments before March 15, 2021.
Summary AI
The Food and Drug Administration (FDA) is inviting public comments on a proposed collection of information concerning device classification and regulatory requirements, as part of their responsibilities under the Paperwork Reduction Act of 1995. The information collection supports regulations and guidance under section 513(g) of the Federal Food, Drug, and Cosmetic Act, which outlines how people can request the FDA's views on device classification and applicable requirements. Individuals can submit comments electronically or by mail by March 15, 2021. Comments should focus on the necessity, accuracy, and potential improvements of the proposed information collection process.
Abstract
The Food and Drug Administration (FDA, Agency, or we) 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 the information collection burden estimate for requests for a written statement from FDA regarding the classification and regulatory requirements that may be applicable to a particular device (513(g) requests).
Keywords AI
Sources
AnalysisAI
The document in question is a notice from the Food and Drug Administration (FDA) published in the Federal Register. This notice serves as a formal announcement inviting public input on a proposed collection of information related to the classification and regulatory requirements for medical devices. The FDA is acting under the mandates of the Paperwork Reduction Act of 1995, which requires federal agencies to provide an opportunity for public comment whenever they propose a new information collection, or plan to extend an existing one.
General Summary
The essence of the document is to request feedback from individuals, businesses, and organizations on the process of gathering information necessary for device classification. Section 513(g) of the Federal Food, Drug, and Cosmetic Act allows people to request the FDA's views on how a device is classified and what regulatory requirements apply to it. The FDA uses this information to help guide their policy-making and ensure that they are meeting the needs of both industry and public safety. Interested parties have until March 15, 2021, to submit their comments, which can be done electronically or via mail.
Significant Issues and Concerns
A few noticeable issues arise from this document:
Complex Legal References: For the layperson, the use of legal references like "44 U.S.C. 3501-3521" and terms such as "5 CFR 1320.3(c)" can be daunting. These references are necessary for legal accuracy but may not be readily understandable to the general public.
Requirement for User Fees: There is a mention of a user fee for 513(g) requests. While not uncommon for regulatory processes, such fees could pose a financial burden on smaller organizations or individual inventors who need clear regulatory guidance.
Complexity in Confidential Submissions: The process to submit confidential information appears cumbersome, requiring dual submissions with specific labeling. This could be overwhelming for individuals who are not familiar with regulatory submission protocols.
Acronyms and Definitions: Acronyms such as FD&C Act, PRA, and OMB are used without explanations, which may be confusing to those unfamiliar with regulatory policies or frameworks.
Public Impact
From a broad perspective, the document's procedures provide an opportunity for public participation in regulatory matters that pertain to medical devices. This open-for-comment cycle is a crucial mechanism in a democratic society, allowing for transparency and incorporation of public input into federal actions. Public feedback can help ensure that FDA's approaches are well-rounded and consider diverse perspectives.
Stakeholder Impact
Industry and Innovators: For medical device manufacturers and developers, understanding regulatory classifications is imperative for market success. The ability to request information regarding device classification can significantly streamline product development and ensure compliance. However, the financial burdens imposed by the user fees may deter smaller stakeholders from fully participating in the request process.
General Public and Consumers: While the document primarily targets industry professionals, it impacts consumers indirectly. The FDA's information collection efforts inform regulatory decisions that ultimately affect consumer safety and access to medical innovations.
Regulatory Bodies: The FDA benefits from this process by gathering organized feedback, which can inform better policy decisions and streamline regulatory procedures.
In summary, while the document's aims are important for regulatory clarity and public safety, several issues may hinder full participation from all stakeholders involved, particularly the smaller entities and individual contributors. Efforts to simplify the language and submission process might enhance engagement and feedback quality.
Issues
• The document uses complex legal references such as '44 U.S.C. 3501-3521' and '5 CFR 1320.3(c)' which may not be easily understandable for the general public.
• The document references multiple URLs and external documents like 'FDA and Industry Procedures for Section 513(g) Requests for Information Under the Federal Food, Drug, and Cosmetic Act' without summarizing their contents, which might be difficult for readers without internet access.
• Potential complexity in submitting confidential information due to dual submission requirements, which can be confusing for individuals unfamiliar with regulatory processes.
• The document includes acronyms and references to specific legislative acts (e.g., FD&C Act, PRA, OMB) without providing definitions or context, which could confuse readers unfamiliar with these terms.
• The requirement for a user fee for 513(g) requests could be perceived as a barrier to smaller organizations or individuals seeking information.
• The language used to describe the submission process and confidentiality is detailed but could be simplified to improve clarity for laypersons.