Description
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers.” This guidance describes FDA’s enforcement policy regarding certain firm-initiated communications of scientific information on unapproved use(s) of the firm’s approved/cleared medical products to health care providers (HCPs) engaged in prescribing or administering medical products to individual patients. This guidance finalizes the revised draft guidance of the same title issued in October 2023. The October 2023 revised draft guidance revised and replaced the draft guidance entitled “Distributing Scientific and Medical Publications on Unapproved New Uses--Recommended Practices,” issued in March 2014, which itself revised the final guidance entitled “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices,” issued in January 2009. This guidance is not for current implementation, pending the Office of Management and Budget’s (OMB’s) decision on the collection of information.
Scope & Applicability
Product Classes
4Medical products that have received FDA approval or clearance; Products that have met FDA premarket requirements; Medical products that have received FDA marketing authorization; medical products subject to SIUU communication guidance
Early-phase randomized, double-blind, parallel assignment clinical study
FDA intends to assess device cybersecurity based on a number of factors; demonstrate or maintain its safety and effectiveness; ensuring cybersecurity has become essential to FDA’s ability to protect the public health; Cyber-resiliency capabilities for medical devices
Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.
Stakeholders
4HCPs engaged in prescribing or administering medical products; Recipients of SIUU communications; Target audience for SIUU communications; audience for SIUU communications and clinical decision makers
Independent organization managing journals for reprints
Entities initiating communications regarding medical products; Applicants, sponsors, manufacturers, packers, and distributors; The entity (manufacturer/distributor) sharing information about medical products; Entities disseminating scientific information on unapproved uses; Entity responsible for generating and disseminating SIUU communications; entity generating presentations regarding medical products
Physicians, veterinarians, dentists, and other licensed professionals
Regulatory Context
Attributes
3Uses of medical products not approved/cleared by FDA
Characteristic of CPGs defined by NAM standards
Uses of medical products not cleared or approved by FDA
Identified Hazards
Hazards
1Example of a severe adverse event in pregnant women
Related CFR Sections (7)
- 21CFR860.7§ 860.7 Determination of safety and effectiveness.
(a) The classification panels, in reviewing evidence concerning the safety and effectiveness of a device and in preparing advice to the Commissioner, and the Commissioner, in making determinations concerning the safety and effectiveness of a device, will apply the rules in this section.Read full regulation →
- 21CFR201.100§ 201.100 Prescription drugs for human use.
A drug subject to the requirements of section 503(b)(1) of the act shall be exempt from section 502(f)(1) if all the following conditions are met:Read full regulation →
- 21CFR201.66§ 201.66 Format and content requirements for over-the-counter (OTC) drug product labeling.
(a) Scope. This section sets forth the content and format requirements for the labeling of all OTC drug products. Where an OTC drug product is the subject of an applicable monograph or regulation that contains content and format requirements that conflict with this section, the content and format reRead full regulation →
- 21CFR514.1§ 514.1 Applications.
(a) Applications to be filed under section 512(b) of the act shall be submitted in the form and contain the information described in paragraph (b) of this section, as appropriate to support the particular submission. If any part of the application is in a foreign language, an accurate and complete ERead full regulation →
- 21CFR201.128§ 201.128 Meaning of “intended uses”.
The words intended uses or words of similar import in §§ 201.5 , 201.115 , 201.117 , 201.119 , 201.120 , 201.122 , and 1100.5 of this chapter refer to the objective intent of the persons legally responsible for the labeling of an article (or their representatives). The intent may be shown by such peRead full regulation →
- 21CFR801.4§ 801.4 Meaning of intended uses.
The words intended uses or words of similar import in §§ 801.5 , 801.119 , 801.122 , and 1100.5 of this chapter refer to the objective intent of the persons legally responsible for the labeling of an article (or their representatives). The intent may be shown by such persons' expressions, the designRead full regulation →
- 21CFR201.56§ 201.56 Requirements on content and format of labeling for human prescription drug and biological products.
(a) General requirements. Prescription drug labeling described in § 201.100(d) must meet the following general requirements:Read full regulation →
Related Warning Letters (10)
- 2025-12-23
Unapproved New Drugs
TITAN SARMS LLC
- 2025-12-23
Unapproved New Drugs
Pinnacle Professional Research dba Pinnacle Peptides
- 2025-12-23
Unapproved New Drugs
Prime Sports Nutrition
- 2025-12-23
Unapproved New Drugs
Atomix LLC
- 2025-12-23
Unapproved New Drugs
Dynamic Health Group dba SARMS AMERICA
- 2025-12-16
Unapproved New Drugs/Misbranded
Musclepower Enterprise Ltd. dba MONSTER KING and GE LABS
- 2025-11-25
Unapproved New Drugs/Adulterated/Misbranded
Handelnine Global, LLC dba Navafresh
- 2025-11-25
Unapproved New Drugs
Swift Digital Group LLC dba Swadesii
- 2025-11-25
Unapproved New Drugs
VarunKart Group LLC dba Organic Wellnesses
- 2025-11-25
Unapproved New Drugs
Distacart Inc.
See Also (8)
- Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- CPG Sec. 345.200 Diaphragms - Rx Devices (Status: Final)
- CPG Sec. 398.200 Hazardous Diagnostic X-ray Systems (Status: Final)
- CPG Sec. 345.300 Menstrual Sponges (Status: Final)
- CPG Sec. 355.300 Ion Generating Devices (Status: Final)
- Guidance Document for the Preparation of IDEs for Spinal Systems - Guidance for Industry and/or FDA Staff (Status: Final)
- Guidance Document for Dura Substitute Devices - Guidance for Industry (Status: Final)
- Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery - Guidance for Industry (Status: Final)