Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions: Guidance for Industry and Food and Drug Administration Staff | Guideline Explorer

Description

Thisguidance documentdescribes the Food and Drug Administration's (FDA or Agency) current approach to considering uncertainty in making benefit-risk determinations to support FDA premarket decisions for medical device premarket approval applications (PMAs), De Novo requests, and humanitarian device exemption (HDE) applications. FDA believes the approach described in this guidance promotes the public health by helping patients have timely access to new medical devices meeting the applicable statutory standard for safety and effectiveness, such that probable benefits of device use outweigh the probable risks and the device will provide clinically significant results in a significant portion of the target population, based on the totality of the valid scientific evidence.

Scope & Applicability

Product Classes

6

Class III Device

Generally recommended for Enhanced Documentation; Regulatory classification mentioned for implantable sensors and HPV tests; Mentioned in the context of an in vitro nucleic acid test for CMV DNA.

Class II Device

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

Class I Device

Low risk medical devices

Breakthrough Devices

Designation for expedited or priority devices under 21st Century Cures Act

Breakthrough Device

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

Humanitarian Use Device

Medical device intended for small populations

Stakeholders

3

Institutional Review Board

Governs top dose in clinical studies

sponsor

responsible for justifying omission of studies

advisory committee

External body providing input on labeling changes

Regulatory Context

Attributes

4

Safety and Effectiveness

Cybersecurity is part of device safety and effectiveness

Sample size

Determined during the planning of a research study

Benefit-Risk Determination

The process of weighing probable benefits against probable risks.

Reasonable Assurance of Safety and Effectiveness

Standard for PMA approval

Related CFR Sections (3)

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 →
21CFR814.82§ 814.82 Postapproval requirements.
(a) FDA may impose postapproval requirements in a PMA approval order or by regulation at the time of approval of the PMA or by regulation subsequent to approval. Postapproval requirements may include as a condition to approval of the device:Read full regulation →
21CFR814.46§ 814.46 Withdrawal of approval of a PMA.
(a) FDA may issue an order withdrawing approval of a PMA if, from any information available to the agency, FDA determines that:Read full regulation →