Breakthrough Devices Program: Guidance for Industry and Food and Drug Administration Staff | Guideline Explorer

Description

FDA is issuing this guidance to describe the policies FDA intends to use to implement section 515B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360e-3), as created by section 3051 of the 21st Century Cures Act (Cures Act), amended by section 901 of the FDA Reauthorization Act of 2017, and amended by Section 3001 of the SUPPORT for Patients and Communities Act (the SUPPORT Act) (the “Breakthrough Devices Program”). The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The Breakthrough Devices Program may also be applicable to certain devices that benefit populations impacted by health and/or healthcare disparities. In addition, consistent with our obligations under the SUPPORT Act, the Breakthrough Devices Program may also be available for certain non-addictive medical products to treat pain or addiction (FD&C Act section 515B (21 U.S.C. 360e-3)). The Breakthrough Program is intended to help patients have more timely access to medical devices by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency’s mission to protect and promote public health.

Key Topics

Terms and concepts identified from this document

Scope & Applicability

Product Classes

3

Combination Product

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.

In Vitro Companion Diagnostic Devices

Devices used to identify patients eligible for specific drug treatments

Breakthrough Device

Devices providing for more effective treatment or diagnosis of life-threatening diseases

Stakeholders

2

Sponsor

Entity responsible for submitting applications under section 524B

Special government employees

Experts FDA may consult to assess standard of care

Regulatory Context

Regulatory Activities

10

PMA

Premarket Approval Application

513(g)

relevant previous communications with FDA about the subject device including 513(g)

IDE

Investigational Device Exemption submissions; Submission Documentation for Investigational Device Exemptions; Investigational Device Exemption submission recommendations

IDE application

Investigational Device Exemption submission

Pre-Submission

Process to obtain FDA feedback on Documentation Level

Q-Submission

System used to track interactions outside of formal marketing submissions; The program for requests for feedback and meetings for medical device submissions.

Breakthrough Device designation request

Request submitted by sponsors to enter the program

510(k)

Premarket notification submission type

De Novo request

Classification request eligible for reduced small business fees

Humanitarian Device Exemption

Marketing submission type requiring QMS information; Regulatory pathway for devices for small patient populations

Document Types

3

Data Development Plan

A program feature involving an example approach for data collection; High-level document outlining data collection expectations for the product lifecycle; Example of information helpful in a DDP

Q-Submission

Submission type used for Breakthrough Device designation requests

Clinical Protocol Agreement

A program feature for designated breakthrough devices; Binding agreement in writing for clinical protocols; Request for agreement not subject to acceptance review

Attributes

4

Reasonable assurance of safety and effectiveness

Statutory standard for PMA approval.

Indications for Use

conformity with an FDA-recognized standard can help demonstrate that an NGS-based test developer has performed the activities necessary to identify the indications for use; number and types of samples used in the study should be statistically justified for the test’s indications for use; If a modification expands the indications for use beyond aiding in the diagnosis of symptomatic individuals; Acceptable performance levels depend on these

Indication for use

Determines the classification of a product

Health equity

Absence of unfair, avoidable differences in health status

Technical Details

Testing Methods

6

Adaptive study designs

Flexible clinical trial design option.

Mechanical fatigue testing

Non-clinical test

Biocompatibility

Required testing if the coil is patient contacting.

Electromagnetic compatibility

Non-clinical test

Statistical analysis plan

Topic for a sprint discussion

In vitro diagnostic product

IVD used for earlier diagnosis of preeclampsia

Processes

1

Sterilization

Required for contaminated equipment and media before disposal

Clinical Concepts

8

Life-threatening diseases

Criterion for device eligibility in the program

Adverse events

Safety findings including deaths and post-mortem examinations

Sickle cell disease

specific blood disorder mentioned as a factor in accuracy

Irreversibly debilitating diseases

Criterion for device eligibility in the program

Addiction

Non-addictive medical products to treat pain or addiction are eligible

Life-threatening

Criterion for Breakthrough Device designation; Criterion for breakthrough designation

Irreversibly debilitating

Criterion for Breakthrough Device designation; Criterion for breakthrough designation

Amyotrophic lateral sclerosis

A disease mentioned in the context of mixed methods study examples.

Identified Hazards

Hazards

1

Morbidity

Substantial impact on day-to-day functioning

Standards & References

External Standards

2

IEC 60601-1-2

Collateral Standard: Electromagnetic disturbances

Medical Device User Fee Amendments of 2017

Commitments for feedback timelines

Specifications

3

Surrogate endpoints

Used in efficient clinical study designs to predict clinical benefit.

Acceptance Criteria

limits for solid state form and particle size; Tightening acceptance criteria; Numerical limits or ranges for tests

Standard of Care

Current clinical practice in the U.S. used as a baseline for comparison

Related CFR Sections (1)

21CFR3.2§ 3.2 Definitions.
For the purpose of this part:Read full regulation →

Enforcement Impact

Deficiencies cited in Warning Letters referencing the same regulations

Adulterated under section 501(f)(1)(B)

22

Misbranded under section 502(o)

20

Failure to establish and maintain procedures to control the design of the device

10

Failure to adequately develop, maintain, and implement written MDR procedures

10

Failure to establish and maintain procedures for implementing corrective and preventive action

10

Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints

8

Unapproved Device Violations

8

Failure to establish and maintain procedures for implementing corrective and preventive actions

8

Failure to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints

8

Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures

7

Recent Cases

Related Warning Letters (10)

Related MFDS Guidelines

Korean regulatory guidelines covering similar topics

혁신의료기기 우선심사 가이드라인
Medium