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Revisions to section 801(e)(4)(E)(iii) of the FD&C Act as part of the Coronavirus Aid, Relief, and Economic Security (CARES) Act direct FDA to provide certification for Devices Not Exported from the U.S. Manufacturers of devices not exported from the United States, as described in section 801(e)(4)(E)(iii) of the FD&C Act, may not receive export certificates (e.g., CFG), but may request a Certificate for Device Not Exported from the United States (CDNE).

A CDNE may be issued for medical devices manufactured outside of the United States that are cleared, approved, granted a De Novo or subject of an approved humanitarian device exemption, on the market prior to May 28, 1976 or exempt from section 510(k) of the FD&C Act, but are not exported from the United States and are identical to the FDA authorized device with no modifications to the technology, intended use, indications for use or labeling.

Recently published Guidance Documents

All Divisions

Certificates of Confidentiality

This guidance describes FDA implementation of the revised provisions applicable to the request for, and issuance of, a Certificate of Confidentiality. The 21st Century Cures Act amended the Public Health Service Act, section 301(d) (42 U.S.C. 241(d)) relating to the issuance of CoCs. A CoC is intended to help protect the privacy of human subject research participants from whom identifiable, sensitive information is being collected or used in furtherance of the research.

CDER

Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA

This guidance describes an enhanced pathway for discussions between FDA and a prospective applicant preparing to submit to FDA or an applicant that has submitted to FDA an abbreviated new drug application (ANDA) for a complex product, as defined in this guidance. Specifically, this guidance provides information on requesting and conducting product development meetings, pre-submission meetings, and mid-review-cycle meetings with FDA.

Clinical Drug Interaction Studies With Combined Oral Contraceptives

This guidance is intended to help sponsors of investigational new drug applications (INDs) and new drug applications (NDAs) evaluate the need for drug-drug interaction (DDI) studies of their investigational drugs with combined oral contraceptives (COCs), design such studies, and determine how to communicate DDI study results and mitigation strategies to address potential risks associated with increased or decreased exposure of COCs in labeling. This guidance focuses on evaluating the DDI potential of an investigational drug (i.e., perpetrator) on a COC (i.e., victim).

Insanitary Conditions at Compounding Facilities

FDA is issuing this guidance to help compounding facilities and state regulatory agencies understand some examples of what FDA considers to be insanitary conditions that could cause a drug product to become contaminated or rendered injurious to health. These examples are intended to help compounding facilities prevent the occurrence of these and other insanitary conditions. This guidance is also intended to help compounding facilities identify and remediate such insanitary conditions when they already exist.

Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products

This guidance provides sponsors with recommendations on the nonclinical information to support development and approval of orally inhaled nicotine-containing drug products, including electronic nicotine delivery systems intended for smoking cessation and related chronic indications.

This guidance focuses on novel chemicals of the drug product formulation, novel chemicals generated from any chemical of the drug product formulation by the delivery system (e.g., heat-generated chemicals), and novel impurities from the drug product formulation and delivery system.

Referencing Approved Drug Products in ANDA Submissions

This guidance is intended to provide information to potential applicants on how to identify a reference listed drug (RLD), reference standard, and the basis of submission in an abbreviated new drug application (ANDA) submission.

CDER & CBER

Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff

Section 3011 of the 21st Century Cures Act (Cures Act) added new section 507, Qualification of Drug Development Tools (DDTs), to the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance meets the Cures Act’s mandate to issue final guidance on the section 507 qualification process. Specifically, this guidance represents the Center for Drug Evaluation and Research’s (CDER’s) and the Center for Biologics Evaluation and Research’s (CBER’s) current thinking on implementation of section 507 of the FD&C Act with respect to describing the process for requestors interested in qualifying DDTs and on taxonomy for biomarkers and other DDTs.

Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act

This draft guidance document provides answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilar products and proposed interchangeable products, as well as describe FDA’s interpretation of certain statutory requirements added by the BPCI Act.

Cross Labeling Oncology Drugs in Combination Regimens

The purpose of this guidance is to describe FDA’s current recommendations about including relevant information in labeling for oncology drugs approved for use in a combination regimen, including important considerations for cross labeling of these drugs. This guidance does not address all issues that might arise relating to labeling for oncology drugs for use in a combination regimen.

Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs

This guidance recommends approaches that sponsors of clinical trials intended to support a new drug application or a biologics license application can take to increase enrollment of underrepresented populations in their clinical trials.

Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017

This guidance provides stakeholders information regarding FDA’s implementation of the Prescription Drug User Fee Amendments of 2017 under Title I of the FDA Reauthorization Act of 2017. Because PDUFA VI created changes to the user fee program, this guidance explains the new fee structure created by the statute, and the types of fees for which entities are responsible.

Providing Regulatory Submissions in Electronic Format – Standardized Study Data

This guidance and the technical specifications documents it incorporates by reference describe the requirements for an electronic submission of standardized clinical and nonclinical study data under section 745A(a) of the FD&C Act. In accordance with section 745A(a), following the issuance of a final guidance on this topic, study data contained in the submission types identified in this guidance must be submitted electronically in a format that FDA can process, review, and archive.

CDRH

Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency (Revised)

This guidance is intended to assist manufacturers in providing timely, informative notifications about changes in the production of certain medical device products that will help prevent or mitigate shortages of such devices during the COVID-19 public health emergency.

This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act.

Enforcement Policy for Bioburden Reduction Systems Using Dry Heat to Support Single-User Reuse of Certain Filtering Facepiece Respirators During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

FDA is issuing this guidance to provide a policy for bioburden reduction systems that use dry heat to help support the single-user reuse of certain particulate filtering facepiece respirators (FFRs).

This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act.

Regulatory Considerations for Microneedling Products

This guidance is being issued to assist industry in understanding when a microneedling product is a device as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act, and is, therefore, subject to the device requirements under the FD&C Act and its implementing regulations. This document also provides information on the regulatory pathway to market for microneedling devices for aesthetic use.

Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised)

FDA is issuing this guidance to provide a policy to help expand the availability and capability of non-invasive remote monitoring devices to facilitate patient monitoring while reducing patient and healthcare provider contact and exposure to COVID-19 for the duration of the COVID-19 public health emergency.

This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act.

Necessary Automated External Defibrillator Accessories: Policy Regarding Compliance Date

FDA is issuing this guidance to revise its compliance policy regarding the deadline for filing premarket approval applications for previously cleared accessories necessary to the operation of automated external defibrillator systems. This policy is based, in part, in consideration of the burden on healthcare facilities as they transition to FDA-approved AEDs and on the manufacturers as they prepare to implement the PMA requirements while addressing the challenges related to Coronavirus Disease 2019 (COVID-19).

CDRH & CBER

Electromagnetic Compatibility (EMC) of Medical Devices

The Food and Drug Administration has developed this guidance document to recommend information that should be provided in a premarket submission (i.e., premarket approval (PMA) application, humanitarian device exemption (HDE), biologics license application (BLA), premarket notification (510(k)) submission, investigational device exemption (IDE) and De Novo request) to demonstrate electromagnetic compatibility for electrically powered medical devices and medical devices with electrical or electronic functions.

Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices

This guidance describes the information that the Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research, in collaboration with the Office of Regulatory Affairs, will provide to a person whose request for a CFG for a device is denied, and the process for seeking review of such a denial.

CBER

Investigational COVID-19 Convalescent Plasma

On August 23, 2020, FDA issued an Emergency Use Authorization for COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19. FDA recognizes that while COVID-19 convalescent plasma may be used under an EUA consistent with the authorization, COVID-19 convalescent plasma may also be used under an investigational new drug application. For the purposes of this guidance, the term “COVID-19 convalescent plasma” refers to the convalescent plasma authorized under the EUA, while the term “investigational convalescent plasma” refers to convalescent plasma that does not meet all the conditions of the EUA and/or is being used under an IND.

FDA is issuing this guidance to provide recommendations to health care providers and investigators on the use of COVID-19 convalescent plasma or investigational convalescent plasma during the public health emergency.

CVM

CVM GFI #242 In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products

This document serves to provide CVM’s current thinking on how to formulate in-use statements for multiple-dose injectable animal drug products as well as how to design and carry out in-use stability studies to support these in-use statements.

CVM GFI #255 Elemental Impurities in Animal Drug Products Questions and Answers

This guidance is intended to assist sponsors of animal drug products in addressing changes in the United States Pharmacopeia (USP)1 requirements for the control of elemental impurities in drug products marketed in the United States.

CVM GFI #197 Documenting Electronic Data Files and Statistical Analysis Programs

For new animal drug applications, FDA requires full reports of investigations which have been conducted to show a drug is safe and effective for use. Additionally, section 512(n)(1)(E) of the FD&C Act requires that abbreviated applications for the approval of a new animal drug contain information to show that the new animal drug is bioequivalent to the approved new animal drug.

Federal Register publications of note

FR Vol 85, No. 228 Termination of the Food and Drug Administration’s Unapproved Drugs Initiative; Request for Information Regarding Drugs Potentially Generally Recognized as Safe and Effective

FR Vol. 85, No. 223 Guidance Documents Related to Coronavirus Disease 2019; Availability

FR Vol. 85, No. 223 Request for Comments on Discretion To Institute Trials Before the Patent Trial and Appeal Board

COVID-19 specific FDA webpages

Personal Protective Equipment EUAs

Face Masks, Including Surgical Masks, and Respirators for COVID-19

Hand Sanitizers / COVID-19 webpage update

FDA updates on hand sanitizers consumers should not use

Removal Lists of Tests that Should No Longer Be Used and/or Distributed for COVID-19: FAQs on Testing for SARS-CoV-2

Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2

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