Draft: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices: Draft Guidance for Industry and Food and Drug Administration Staff | Guideline Explorer

Scope & Applicability

Product Classes

5

Medical Devices

Medical devices intended for human use; Approved or cleared medical devices

Class II Device

Devices subject to section 522 postmarket surveillance orders; devices subject to postmarket surveillance orders

Class I Device

Low risk medical devices

Medical Device

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

Digital health technologies

Systems using computing platforms, software, or sensors

Stakeholders

3

Sponsor

Entity responsible for submitting applications under section 524B

Manufacturer

Entity responsible for submitting NDINs

Institutional Review Board

Governs top dose in clinical studies

Regulatory Context

Attributes

5

Fit-for-purpose

Status of PRO instruments for regulatory decision-making.

Statistical Power

adequate statistical power and accounting for planned analyses

Reliability

reliability includes accuracy, completeness, and traceability

Relevance

relevance includes the availability of data for key study variables

Valid scientific evidence

Standard required to substantiate safety and effectiveness.

Identified Hazards

Hazards

1

Bias

mitigate potential unwanted bias in learning or performance estimation

Related CFR Sections (6)

21CFR801.40§ 801.40 Form of a unique device identifier.
(a) Every unique device identifier (UDI) must meet the technical requirements of § 830.20 of this chapter . The UDI must be presented in two forms:Read full regulation →
21CFR830.3§ 830.3 Definitions.
As used in this part:Read full regulation →
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 →
21CFR812.1§ 812.1 Scope.
(a) The purpose of this part is to encourage, to the extent consistent with the protection of public health and safety and with ethical standards, the discovery and development of useful devices intended for human use, and to that end to maintain optimum freedom for scientific investigators in theirRead full regulation →
21CFR812.2§ 812.2 Applicability.
(a) General. This part applies to all clinical investigations of devices to determine safety and effectiveness, except as provided in paragraph (c) of this section.Read full regulation →
21CFR812.3§ 812.3 Definitions.
(a) Act means the Federal Food, Drug, and Cosmetic Act (sections 201-901, 52 Stat. 1040 et seq., as amended ( 21 U.S.C. 301-392 )).Read full regulation →

Related Warning Letters (10)

CGMP/QSR/Medical Devices/Adulterated/Misbranded
Royal Philips
2025-10-28
Medical Device Reporting/Misbranded
Insung Medical Co. Ltd.
2025-09-30
Clinical Investigator
Shirish M. Gadgeel, M.D.
2025-09-09
Clinical Investigator
Mark J. Savant, M.D
2025-07-15
Medical Device Reporting/Misbranded
Insightra Medical Inc.
2025-07-08
CGMP/QSR/Medical Devices/Adulterated
Aju Pharm Co., Ltd.
2025-06-24
CGMP/QSR/Medical Devices/Adulterated
DFI Co., Ltd.
2025-06-03
Bioresearch Monitoring Program/Institutional Review Board (IRB)
United Health Products, Inc.
2025-05-20
CGMP/QSR/Medical Devices/Adulterated
EpiCare Acquisitions, LLC
2025-04-08
Clinical Investigator
Americo F. Padilla, M.D.
2025-03-25