Description
This points-to-considerdocumentsupplements existing FDA guidance for premarket submission of in vitro diagnostic devices for approval or clearance. The information requested is intended to be comprehensive but may not be all inclusive. The emphasis is on FDA's particular concerns in the review of cytology devices for gynecologic specimens.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
3Subject of the points-to-consider document; Guidance document title and subject of clinical study requirements; The primary subject of the guidance document.; Subject of the guidance document regarding points to consider for regulatory submission.
Devices compared to reference methods or gold standards
Reference method for cervical cytology
Stakeholders
4responsible for justifying omission of studies
Entity responsible for submitting NDINs
Professional screening specimens for analysis.; Role responsible for referring slides to the next higher trained observer.
Performs histopathological assessment of biopsies
Regulatory Context
Regulatory Activities
4Regulatory filing such as a 510(k) or PMA submitted to the FDA.; Submission including ASCA testing results
Premarket notification submission type
Premarket Approval Application
A medical device submission type (IDE).
Document Types
4Submitted to an existing active IND
Original records where data and diagnoses are recorded and must be maintained.
Definitions, algorithms, and data elements should be included in the study protocol.
Required documentation for using negative archival slides
Attributes
5A functional role of sodium in food
Evaluation required for all gynecologic cytology devices submitted for FDA approval.
the biomarker's clinical sensitivity, specificity, and positive and negative predictive values should be well characterized
used to inform the choice of a biomarker cutoff
Required data for pediatric population estimates
Technical Details
Testing Methods
10Over 50 million performed each year
Conventional methodology used as a baseline for comparison with new devices.
Used to verify abnormal cells identified by computer-assisted devices.
technique to detect epithelial disruption and local malignancy
Clinical endpoint or surrogate endpoint
Commonly used to address uncertainty in the assessment of a treatment effect; The graph shows each of the hypotheses located at a vertex.
Sampling requirement for specific conditions claimed in intended use.
Sampling requirement for specific conditions claimed in intended use.
Conventional method used as a reference for cervical cytology.
A reference method for accuracy, though less than a gold standard.
Processes
3Studies conducted to detect or analyze conditions before marketing.
In vitro methods for product quality and performance assessments
Processing method for cervical cells from mucus and other materials.
Clinical Concepts
6Atypical squamous cells of undetermined significance
TBS diagnosis category (ASCUS).
TBS diagnosis category (HGSIL).
Low grade squamous intraepithelial lesion
High grade squamous intraepithelial lesion
Atypical glandular cells of undetermined significance
Identified Hazards
Hazards
1Required for computer controlled medical devices.
Standards & References
External Standards
2Confirmatory test must be performed according to TBS guidelines; Standard for cervical cytology diagnoses (TBS); TBS categories used for screening diagnoses and reporting cervical/vaginal cytological diagnosis.
System used to categorize cervical diseases and conditions (TBS).
Specifications
3Define and document a minimum set of metrics (e.g., accuracy)
Define and document a minimum set of metrics (e.g., precision)
The validation end-point for in vitro diagnostic methods.
Related CFR Sections (3)
- 21CFR884.4530§ 884.4530 Obstetric-gynecologic specialized manual instrument.
(a) Identification. An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief Read full regulation →
- 21CFR864.3800§ 864.3800 Automated slide stainer.
(a) Identification. An automated slide stainer is a device used to stain histology, cytology, and hematology slides for diagnosis.Read full regulation →
- 21CFR864.5260§ 864.5260 Automated cell-locating device.
(a) Identification. An automated cell-locating device is a device used to locate blood cells on a peripheral blood smear, allowing the operator to identify and classify each cell according to type. (Peripheral blood is blood circulating in one of the body's extremities, such as the arm.)Read full regulation →