Medical Device Accessories

ICR 201908-0910-010

OMB: 0910-0823

Federal Form Document

Forms and Documents
Supporting Statement A
ICR Details
0910-0823 201908-0910-010
Active 201606-0910-001
Medical Device Accessories
Extension without change of a currently approved collection   No
Approved without change 09/24/2019
Retrieve Notice of Action (NOA) 08/21/2019
  Inventory as of this Action Requested Previously Approved
09/30/2022 36 Months From Approved 09/30/2019
25 0 8
1,000 0 1,440
0 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

  84 FR 13296 04/04/2019
84 FR 40067 08/13/2019

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

  Total Approved 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 25 8 0 0 17 0
Annual Time Burden (Hours) 1,000 1,440 0 0 -440 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Our estimated burden for the information collection reflects an overall decrease of 440 hours and an increase of 17 responses. Factors contributing to the revision of the burden estimate include the addition of the two new accessory classification pathways crated by FDARA and the removal of redundant burden described earlier in this document.

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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