Description
For questions regarding this document contact Colin Pollard, at (240) 276-4155, or by email atcolin.pollard@fda.hhs.gov.
Scope & Applicability
Product Classes
5Subject of the premarket notification guidance; apply this guidance document to 510(k)s for menstrual tampons or pads; Subject of the guidance document regarding premarket notification; Devices addressed in this guidance document
One of the primary menstrual products covered by the guidance scope.; external menstrual products
apply this guidance document to 510(k)s for menstrual tampons or pads; Subject of the guidance document regarding premarket notification
not intralabial pads or reusable menstrual pads are excluded from the scope
If your device contains a drug or biologic, it is a combination product; Device containing a drug or biologic
Stakeholders
1Entity responsible for submitting NDINs
Regulatory Context
Attributes
3A specific property of menstrual products to be described in submissions.; standardization for user safety
Risk classification for investigational devices
Tampon absorbency level of 15-18 grams
Identified Hazards
Hazards
4risk associated with tampon use
Warning statement recommended for scented tampons
Risk management information should identify hazardous situations such as adverse tissue reaction.
Identified risk for tampons
Related CFR Sections (6)
- 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 →
- 21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information:Read full regulation →
- 21CFR812.2§ 812.2 Applicability.
(a) General. This part applies to all clinical investigations of devices to determine safety and effectiveness, except as provided in paragraph (c) of this section.Read full regulation →
- 21CFR884.5425§ 884.5425 Scented or scented deodorized menstrual pad.
(a) Identification. A scented or scented deodorized menstrual pad is a device that is a pad made of cellulosic or synthetic material which is used to absorb menstrual or other vaginal discharge. It has scent (i.e., fragrance materials) added for aesthetic purposes (scented menstrual pad) or for deodRead full regulation →
- 21CFR884.5435§ 884.5435 Unscented menstrual pad.
(a) Identification. An unscented menstrual pad is a device that is a pad made of cellulosic or synthetic material which is used to absorb menstrual or other vaginal discharge. This generic type of device includes sterile unscented menstrual pads used for medically indicated conditions, but does not Read full regulation →
- 21CFR801.430§ 801.430 User labeling for menstrual tampons.
(a) This section applies to scented or scented deodorized menstrual tampons as identified in § 884.5460 and unscented menstrual tampons as identified in § 884.5470 of this chapter .Read full regulation →
Related Warning Letters (10)
- 2025-12-09
CGMP/QSR/Medical Devices/Adulterated
Envoy Medical Inc.
- 2025-11-25
CGMP/QSR/Medical Devices/Adulterated
Hong Qiangxing Shenzhen Electronics Limited
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated
Contec Medical Systems Co., Ltd.
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Royal Philips
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Qianjiang Kingphar Medical Material Co Ltd.
- 2025-10-21
CGMP/QSR/Medical Devices/Adulterated
LEVO AG
- 2025-10-07
CGMP/QSR/Medical Devices/Adulterated
Technological Medical Advancements LLC
- 2025-09-23
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
The Richline Group, Inc.
- 2025-09-16
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
SeniorLife Technologies, Inc.
- 2025-09-09
Clinical Investigator
Shirish M. Gadgeel, M.D.
See Also (8)
- Bone Anchors - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Device Labeling Guidance #G91-1 (Blue Book Memo) (Status: Final)
- CPG Sec. 310.100 Pacemaker Reuse (Status: Final)
- Immunotoxicity Testing Guidance (Status: Final)
- General/Specific Intended Use - Guidance for Industry (Status: Final)
- Dental Handpieces - Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff (Status: Final)
- Medical Glove Guidance Manual: Guidance for Industry and FDA Staff (Status: Final)
- Hemodialysis Blood Tubing Sets - Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff (Status: Final)