Description
The Food and Drug Administration (FDA) is issuingthis guidance documentto provide clarity to industry and FDA staff on the Center for Devices and Radiological Health's (CDRH's) compliance policy for low risk products that promote a healthy lifestyle (general wellness products).1This guidance does not apply to products (e.g., drugs, biologics, dietary supplements, foods, or cosmetics) regulated by other FDA Centers or to combination products.2
Scope & Applicability
Product Classes
5low risk products that promote a healthy lifestyle
Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.
Products intended for maintaining or encouraging a general state of health
Devices subject to section 522 postmarket surveillance orders; devices subject to postmarket surveillance orders
A product that meets both factors for a low risk general wellness product.
Regulatory Context
Attributes
3Criteria for a product to be covered by the general wellness policy
Product that penetrates or pierces the skin or mucous membranes; If the product is intended to enhance delivery of active pharmaceutical ingredients, the product would be invasive.
The product is noninvasive as it does not penetrate the stratum corneum.
Identified Hazards
Hazards
3Risk that may pose a safety concern to users; Risks from lasers or radiation exposure.
Risk associated with neurostimulation products
Risks from lasers or radiation exposure.
Related CFR Sections (5)
- 21CFR3.2§ 3.2 Definitions.
For the purpose of this part:Read full regulation →
- 21CFR809.10§ 809.10 Labeling for in vitro diagnostic products.
(a) The label for an in vitro diagnostic product shall state the following information, except where such information is not applicable, or as otherwise specified in a standard for a particular product class or as provided in paragraph (e) of this section. Section 201(k) of the act provides that “a Read full regulation →
- 21CFR890.3420§ 890.3420 External limb prosthetic component.
(a) Identification. An external limb prosthetic component is a device intended for medical purposes that, when put together with other appropriate components, constitutes a total prosthesis. Examples of external limb prosthetic components include the following: Ankle, foot, hip, knee, and socket comRead full regulation →
- 21CFR890.3500§ 890.3500 External assembled lower limb prosthesis.
(a) Identification. An external assembled lower limb prosthesis is a device that is intended for medical purposes and is a preassembled external artificial limb for the lower extremity. Examples of external assembled lower limb prostheses are the following: Knee/shank/ankle/foot assembly and thigh/kRead full regulation →
- 21CFR876.5020§ 876.5020 External penile rigidity devices.
(a) Identification. External penile rigidity devices are devices intended to create or maintain sufficient penile rigidity for sexual intercourse. External penile rigidity devices include vacuum pumps, constriction rings, and penile splints which are mechanical, powered, or pneumatic devices.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
- 2025-09-30
Medical Device Reporting/Misbranded
Insung Medical Co. Ltd.
- 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.
See Also (8)
- ICH Q12: Implementation Considerations for FDA-Regulated Products: Draft Guidance for Industry (Status: Draft)
- Development of Local Anesthetic Drug Products With Prolonged Duration of Effect (Status: Draft)
- Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products: Draft Guidance for Industry (Status: Draft)
- Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
- The Least Burdensome Provisions: Concept and Principles: Guidance for Industry and FDA Staff (Status: Final)
- CPG Sec. 398.450 Applicability of Positive Beam Limitation (PBL) Requirements When PBL is Provided on "Other than Stationary General Purpose" Radiographic System (Status: Final)
- Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators (Status: Final)
- CPG Sec. 398.300 Registration of Assemblers of Diagnostic X-Ray Systems as Device Manufacturers (Status: Final)