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Federal Register / Vol. 86, No. 165 / Monday, August 30, 2021 / Notices Ave., Bldg. 66, Rm. 1613, Silver Spring, MD 209930002, 3017964908.
SUPPLEMENTARY INFORMATION:
I. Background These draft device-specific guidance documents provide performance criteria for premarket notification 510k submissions to support the optional Safety and Performance Based Pathway, as described in the guidance entitled Safety and Performance Based Pathway. As described in that guidance, substantial equivalence is rooted in comparisons between new devices and predicate devices. However, the Federal Food, Drug, and Cosmetic Act does not preclude FDA from using performance criteria to facilitate this comparison. If a legally marketed device performs at certain levels relevant to its safety and effectiveness, and a new device meets those levels of performance for the same characteristics, FDA could find the new device as safe and effective as the legally marketed device. Instead of reviewing data from direct comparison testing between the two devices, FDA
could support a finding of substantial equivalence with data demonstrating the new device meets the level of performance of an appropriate predicate devices. Under this optional Safety and Performance Based Pathway, a submitter could satisfy the requirement to compare its device with a legally marketed device by, among other things,
II. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https www.fda.gov/medical-devices/
device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. These guidance documents are also available at https www.regulations.gov and at https www.fda.gov/regulatory-

information/search-fda-guidancedocuments. Persons unable to download an electronic copy of Denture Base ResinsPerformance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff document number 20001 or Facet Screw SystemsPerformance Criteria for Safety and Performance Based Pathway;
Draft Guidance for Industry and Food and Drug Administration Staff document number 21001 may send an email request to CDRH-Guidance@
fda.hhs.gov to receive an electronic copy of the document. Please use the document number and complete title to identify the guidance you are requesting.
III. Paperwork Reduction Act of 1995
While these guidance documents contain no new collection of information, they do refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget OMB under the Paperwork Reduction Act of 1995 PRA 44 U.S.C. 3501
3521 is not required for this guidance.
The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in the following FDA
regulation and guidance have been approved by OMB as listed in the following table:

21 CFR part; guidance; or FDA form
Topic
807, subpart E
Requests for Feedback and Meetings for Medical Device Submissions: The QSubmission Program.

Premarket notification
Q-submissions; Pre-submissions

Dated: August 24, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
FR Doc. 202118592 Filed 82721; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration khammond on DSKJM1Z7X2PROD with NOTICES

independently demonstrating that the devices performance meets performance criteria as established in the above-listed guidance documents, when finalized, rather than using direct predicate comparison testing for some of the performance characteristics.
These draft guidance documents are being issued consistent with FDAs good guidance practices regulation 21 CFR
10.115. These draft guidance documents, when finalized, will represent the current thinking of FDA
on performance criteria for the Safety and Performance Based Pathway for Denture Base Resins and Facet Screw Systems. They do not establish any rights for any person and are not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

Docket No. FDA2018D1216

Electronic Common Technical Document; Data Standards;
Specifications for Electronic Common Technical Document Validation Criteria Food and Drug Administration, Health and Human Services HHS.

AGENCY:

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ACTION:

Notice.

The Food and Drug Administrations FDA or Agency Center for Drug Evaluation and Research CDER is announcing the date that FDA
will begin rejecting submissions that fail either Electronic Common Technical Document eCTD validation 1551 or 1553, which are high severity validation errors as described in the Specifications for eCTD Validation Criteria. Validation errors 1551 and 1553 have been added to the Specifications for eCTD
Validation Criteria.
DATES: Rejection for failing to pass either eCTD validation 1551 or 1553
under a submission to CDER will begin on October 18, 2021.
FOR FURTHER INFORMATION CONTACT:
Jonathan Resnick, Center for Drug Evaluation and Research, Food and SUMMARY:

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Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3160, Silver Spring, MD 209930002, 301
7967997, Jonathan.Resnick@
fda.hhs.gov.
FDAs CDER is issuing this Federal Register notice to announce that eCTD
validations 1551 and 1553 have been added to the Specifications for eCTD
Validation Criteria available at https
www.fda.gov/media/87056/download as high validation errors. Beginning October 18, 2021, FDA will reject submissions that fail either of these validations.
Under section 745Aa 21 U.S.C.
379k1a of the Federal Food, Drug, and Cosmetic Act FD&C Act, at least 24 months after the issuance of a final guidance document in which FDA has
SUPPLEMENTARY INFORMATION:

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