Description
U.S. Department Of Health and Human ServicesFood and Drug AdministrationCenter for Devices and Radiological Health
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
3legally marketed device used for substantial equivalence comparison
Subject of the guidance
The devices that are the subject of this guidance are Class II non-spinal metallic bone screws and washers
Stakeholders
1Entity responsible for submitting NDINs
Regulatory Context
Regulatory Activities
1Premarket notification submission type
Document Types
4Premarket submission contents include a Declaration of Conformity.; Document included in premarket submission; Example ASCA Declaration of Conformity (DOC) for Basic Safety
You should submit your test method or protocol.
Required element of the test design considerations.
Regulatory requirement for submission
Attributes
1Determined based on stability data; Established through stability testing; also called dating period.; Established through formal stability studies; Establishing the period during which a drug product is expected to remain within specifications; Period for drug products; The period during which a drug product is expected to remain within specifications; Duration product remains within acceptance criteria; Period during which product remains within specifications; Established for intermediates pu
Technical Details
Testing Methods
1Demonstration of substantial equivalence for non-automated sphygmomanometers
Processes
1Required for contaminated equipment and media before disposal
Clinical Concepts
1Sounds detected during manual blood pressure measurement
Standards & References
External Standards
2Standard for performance testing of blood pressure cuffs
Standard for non-automated sphygmomanometers
Specifications
1Predefined limits used to evaluate test results
Related CFR Sections (4)
- 21CFR807.93§ 807.93 Content and format of a 510(k) statement.
- 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 →
- 21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information:Read full regulation →
- 21CFR870.1120§ 870.1120 Blood pressure cuff.
(a) Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.Read full regulation →
Related MFDS Guidelines
Korean regulatory guidelines covering similar topics
See Also (8)
- CPG Sec. 310.100 Pacemaker Reuse (Status: Final)
- Device Labeling Guidance #G91-1 (Blue Book Memo) (Status: Final)
- Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
- Predetermined Change Control Plans for Medical Devices: Draft Guidance for Industry and FDA Staff (Status: Draft)
- 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 (Status: Draft)
- Refuse to Accept Policy for 510(k)s: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Medical Glove Guidance Manual: Guidance for Industry and FDA Staff (Status: Final)
- Guidance for Over-the-Counter (OTC) Human Chorionic Gonadotropin (hCG) 510(k)s - Guidance for Industry and FDA Reviewers/Staff (Status: Final)