[Federal Register Volume 85, Number 90 (Friday, May 8, 2020)]
[Notices]
[Page 27419]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-09832]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-5319]


Notice of Followup to Notice of Public Hearing and Request for 
Comments on Devices Proposed for a New Use With an Approved, Marketed 
Drug

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing a followup on a Federal Register document issued on 
September 26, 2017, that announced a public hearing and requested 
comments on a potential approach to enable device sponsors to obtain 
marketing authorization for their products labeled for a new use with 
an approved, marketed drug when the sponsor for the approved drug does 
not wish to pursue or collaborate on the new use, referred to in the 
notice as devices referencing drugs (DRDs). After further consideration 
and in light of the comments received, FDA does not intend to pursue 
the potential approach described in the referenced Federal Register 
document at this time.

FOR FURTHER INFORMATION CONTACT: John Barlow Weiner, Office of 
Combination Products, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 32, Rm. 5130, Silver Spring, MD 20993, 301-796-8941, 
combination@fda.gov.

SUPPLEMENTARY INFORMATION: FDA issued a Federal Register document on 
September 26, 2017 (82 FR 44803), entitled ``Devices Proposed for a New 
Use With an Approved, Marketed Drug; Public Hearing; Request for 
Comments''. The document announced a public hearing and requested 
comments on a potential approach to enable device sponsors to obtain 
marketing authorization for their products labeled for a new use with 
an approved, marketed drug when the sponsor for the approved drug does 
not wish to pursue or collaborate on the new use. Such new uses 
generally involve a change in how the drug is used or administered, 
such as a change in dose, route, or rate of administration, or use of 
the approved drug for an indication for which it is not approved. As 
discussed in the document, such DRDs raise unique public health, 
scientific, regulatory, and legal issues, which the potential approach 
was intended to address. However, after further consideration and in 
light of the comments received during the public hearing and submitted 
to the docket, FDA does not intend to pursue the potential approach 
described in the document at this time.

    Dated: May 1, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-09832 Filed 5-7-20; 8:45 am]
BILLING CODE 4164-01-P


