Medical Device Accessories

ICR 202202-0910-002

OMB: 0910-0823

Federal Form Document

Forms and Documents
Supporting Statement A
ICR Details
0910-0823 202202-0910-002
Received in OIRA 201908-0910-010
Medical Device Accessories
Extension without change of a currently approved collection   No
Regular 08/19/2022
  Requested Previously Approved
36 Months From Approved 09/30/2022
15 25
600 1,000
0 0

The guidance document “Medical Device Accessories--Describing Accessories and Classification Mechanisms for Accessory Types” encourages manufacturers and other parties to utilize the “de novo request” process defined in section 513(f)(2) of the FD&C Act to request risk-based classifications of new types of medical device accessories. This process provides a pathway to class I or class II classification for accessory devices for which general controls, or general and special controls, provide a reasonable assurance of safety and effectiveness, but for which there is no legally marketed predicate device. Under the de novo request process, manufacturers and other parties may submit a de novo requesting that FDA make a classification determination for the accessory device. The de novo must include a description of the device and detailed information and reasons for any recommended classification.

US Code: 21 USC 321 Name of Law: FD&C Act

Not associated with rulemaking

  87 FR 14891 03/16/2022
87 FR 49850 08/12/2022

IC Title Form No. Form Name
Accessory classification de novo request

  Total Request Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 15 25 0 0 -10 0
Annual Time Burden (Hours) 600 1,000 0 0 -400 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Based on an evaluation of the information collection, we have reduced the estimated number of existing requests from 15 to 10, and we have reduced the estimated number of new requests from 10 to 5. This adjustment results in an overall reduction to the information collection by 10 responses and 400 hours annually. We believe these adjustments more accurately reflect the current number of requests associated with medical device accessory classifications.

Amber Sanford 301 796-8867 [email protected]


On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

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