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
10Implant, Hormone Shot, Combined Pill, and Minipill
Copper T and Progesterone T methods
Barrier method containing spermicide
Information for a Male Latex Condom 510(k) Submission
use a latex condom to help reduce the risk of transmission of many STDs
labeling for natural skin condoms
contraceptive devices including tubal occlusion devices (TODS)
contraceptive devices including intrauterine devices (IUDs)
contraceptive devices including cervical caps; claims for STD protection afforded by cervical caps
contraceptive devices including diaphragms; clinical studies of diaphragms and vaginal spermicides regarding STD protection
Stakeholders
1Entity responsible for submitting NDINs
Regulatory Context
Regulatory Activities
2Required for changes affecting safety and effectiveness.; Submission for modifications to an approved PMA
Premarket notification submission type
Document Types
4Memorandum on Uniform Contraceptive Effectiveness Labeling
Labeling information including dosage, administration, and safety sections
Cornerstone of risk management efforts for prescription drugs
uniform approach to this type of labeling information for the consumer
Attributes
4method was always used correctly with every act of sexual intercourse but failed anyway
estimates of the percent of women likely to become pregnant while using a particular contraceptive method
inclusion of a contraceptive efficacy table in the labeling
table with the pregnancy rates associated with all methods
Technical Details
Substances
5Active component in Progesterone T IUD
Essential trace element in both animals and humans.
COCs usually contain two synthetic steroid hormones, a progestin and an estrogen.; Hormonal component of COCs
COCs usually contain two synthetic steroid hormones, a progestin and an estrogen.
clinical studies of diaphragms and vaginal spermicides
Clinical Concepts
10protection from a few STDs
Treponema pallidum infection
blood-borne pathogen risk for blood-contaminated devices
Infection requiring a 3-month deferral; Infection requiring 3-month deferral after treatment
transmission of STDs including genital warts
transmission of STDs including genital herpes
transmission of STDs including chlamydia
Acquired Immunodeficiency Syndrome
Comorbidity that should not exclude participants from clinical trials
protection from sexually transmitted diseases (STDs)
Standards & References
External Standards
1pregnancy rates based on data from Trussell, et al, from the 17th edition
Related MFDS Guidelines
Korean regulatory guidelines covering similar topics
See Also (8)
- Product Labeling for Laparoscopic Power Morcellators: Guidance for Industry and Food and Drug Administration Staff
- Postmarket Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff
- Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH): Guidance for Industry and Food and Drug Administration Staff
- Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions: Guidance for Industry and Food and Drug Administration Staff
- Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff
- Minimizing Risk for Children's Toy Laser Products: Guidance for Industry and Food and Drug Administration Staff
- Investigational IVDs Used in Clinical Investigations of Therapeutic Products: Draft Guidance for Industry, Food and Drug Administration Staff, Sponsors, and Institutional Review Boards
- Premarket Notification [510(k)] Submissions for Chemical Indicators - Guidance for Industry and FDA Staff