Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission: Draft Guidance for Industry and Food and Drug Administration Staff

Description

FDA is issuing this draft guidance to provide our current thinking on the use of best practices in selecting a predicate device in 510(k) submissions to enhance the predictability, consistency, and transparency of the 510(k) Program. FDA developed this draft guidance in response to public feedback, and to continue to modernize the framework for 510(k) review. The recommendations in this draft guidance propose factors for consideration as best practices for choosing a predicate device that focus on characteristics of the predicate, including selecting a predicate device that was cleared using well-established methods, meets or exceeds expected safety and performance, is without unmitigated use-related or design-related safety issues, and is without an associated design-related recall. FDA believes use of these best practices will encourage the evolution of safer and more effective medical devices in the 510(k) Program over time.

Scope & Applicability

Regulatory Context

• 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 →

• 21CFR807.93§ 807.93 Content and format of a 510(k) statement.

  (a)Read full regulation →

• 21CFR807.81§ 807.81 When a premarket notification submission is required.

  (a) Except as provided in paragraph (b) of this section, each person who is required to register his establishment pursuant to § 807.20 must submit a premarket notification submission to the Food and Drug Administration at least 90 days before he proposes to begin the introduction or delivery for inRead full regulation →

• CGMP/QSR/Medical Devices/Adulterated

  Envoy Medical Inc.

  2025-12-09

• CGMP/QSR/Medical Devices/Adulterated

  Hong Qiangxing Shenzhen Electronics Limited

  2025-11-25

• CGMP/QSR/Medical Devices/Adulterated

  Spectra Therapy, LLC

  2025-08-12

• CGMP/QSR/Medical Devices/Adulterated

  Mectronic Medicale S.R.L.

  2025-08-05

• CGMP/QSR/Medical Devices/Adulterated

  Aju Pharm Co., Ltd.

  2025-06-24

• CGMP/QSR/Medical Devices/Adulterated

  Sedecal S.A.

  2025-05-27

• CGMP/QSR/Medical Devices/Adulterated

  NeuroSync, Inc.

  2025-05-20

• Noah Medical Corporation

  2025-04-22

• CGMP/QSR/Medical Devices/Adulterated

  EpiCare Acquisitions, LLC

  2025-04-08

• Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device

  Exer Labs, Inc.

  2025-03-25

• Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
• CPG Sec. 325.100 Karaya Gum Powder and Related Devices for Use by Ostomates (Status: Final)
• Device Labeling Guidance #G91-1 (Blue Book Memo) (Status: Final)
• CPG Sec. 310.100 Pacemaker Reuse (Status: Final)
• CPG Sec. 390.425 Records and Reports; Applicability - 21 CFR 1002.1 (Status: Final)
• Checklist of Information Usually Submitted in an Investigational Device Exemptions (IDE) Application for Refractive Surgery Lasers [excimer] (Status: Final)
• Immunotoxicity Testing Guidance (Status: Final)
• Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Sharps Containers (Status: Final)