Description
This guidance outlines FDA's current thinking on key aspects of the 510(k) Third Party Review Program and third party review of Emergency Use Authorization (EUA) requests by describing FDA's expectations for the review of 510(k) submissions and EUA requests by third party review organizations. This guidance provides updated recommendations on the 510(k) Third Party Review Program and supersedes the "510(k) Third Party Review Program" guidance.
Scope & Applicability
Product Classes
9Low risk medical devices
Specific category of medical devices mentioned for EUA review
Specific category of medical device mentioned for EUA.
removed from eligibility for the 3P510k Review Program due to safety signals
Devices subject to section 522 postmarket surveillance orders; devices subject to postmarket surveillance orders
IVD device clinical studies conducted on de-identified specimens
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.
IVDs requiring UDI on labels
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
10Entities recognized by FDA to review 510(k) submissions and EUA requests.; Organizations responsible for reviewing scientific and technical data; Entities performing reviews of 510(k) and EUA submissions
Entities that perform regulatory reviews as defined by IMDRF
Supervisory personnel at the 3P510k RO
External individuals used by review organizations for specialized knowledge; Personnel involved in the evaluation of 510(k)s
The entity providing information for the AFIC process.
Third Party Review Organization for 510(k) submissions
Personnel assigned by a Third Party Review Organization to conduct substantive review.; Primary reviewer responsible for leading the organization's review team; Personnel assigned to conduct substantive review of a submission; Individual within the RO performing the review.; Qualified individual required for each device type recognized
Personnel assigned by a Third Party Review Organization for final review of a submission.; Individual within the Third Party Review Organization who oversees the review process; Independent individual responsible for final supervisory assessment; Individual providing final supervisory assessment at the RO.; A cover letter signed by the Final Reviewer that clearly identifies the purpose of the submission.
Personnel or external experts involved in the substantive review of a submission.; Individual who provides specific knowledge or expertise; Qualified individual added to review team for specific competency
Qualified third parties recognized to conduct initial reviews of 510(k) submissions
Identified Hazards
Hazards
3Information suggesting a new potentially causal association or a new aspect of a known association between an intervention and an event.
Condition for suspension or withdrawal of recognition
Complaints regarding submitters that indicate safety issues
Related CFR Sections (7)
- 21CFR10.75§ 10.75 Internal agency review of decisions.
(a) A decision of an FDA employee, other than the Commissioner, on a matter, is subject to review by the employee's supervisor under the following circumstances:Read full regulation →
- 21CFR20.61§ 20.61 Trade secrets and commercial or financial information which is privileged or confidential.
(a) A trade secret may consist of any commercially valuable plan, formula, process, or device that is used for the making, preparing, compounding, or processing of trade commodities and that can be said to be the end product of either innovation or substantial effort. There must be a direct relationRead full regulation →
- 21CFR807.95§ 807.95 Confidentiality of information.
(a) The Food and Drug Administration will disclose publicly whether there exists a premarket notification submission under this part:Read full regulation →
- 21CFR10.70§ 10.70 Documentation of significant decisions in administrative file.
(a) This section applies to every significant FDA decision on any matter under the laws administered by the Commissioner, whether it is raised formally, for example, by a petition or informally, for example, by correspondence.Read full regulation →
- 21CFR807.100§ 807.100 FDA action on a premarket notification.
(a) After review of a premarket notification, FDA will:Read full regulation →
- 21CFR807.92§ 807.92 Content and format of a 510(k) summary.
(a) A 510(k) summary shall be in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence. FDA will accept summaries as well as amendments thereto until such time as FDA issues a determination of substantial equivalence. All 510(k) summaries shall conRead full regulation →
- 21CFR809.3§ 809.3 Definitions.
(a) In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use Read full regulation →
See Also (8)
- Best Practices for Communication Between IND Sponsors and FDA During Drug Development (Status: Final)
- Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry (Status: Draft)
- Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP (Status: Final)
- Bundling Multiple Devices or Multiple Indications in a Single Submission: Guidance for Industry and FDA Staff (Status: Final)
- How to Write a Request for Designation (RFD): Guidance for Industry (Status: Final)
- Safety Labeling Changes -- Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (Status: Final)
- CVM GFI #79 Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by CVM (Status: Final)
- Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments: Guidance for Industry (Status: Final)