Description
According to the FDA Compliance Policy Guide No. 7133.11 (dated October 1, 1980) an x-ray system designed for and limited by its design for diagnostic purposes to only one of the following body regions is classified as "other than general purpose" for the purpose of Section 1020.31.
Scope & Applicability
Product Classes
6Subject of the premarket notification guidance; Subject of the 510(k) review requirements; Device requiring barrier features and specifications in critical areas; Medical device subject to 510(k) submission
product with multiple components like vials and packets
Subject of the premarket notification guidance; Subject of the 510(k) review requirements; Device requiring sterility assurance level of 10-6; Medical device subject to 510(k) submission
Branch responsible for the guidance
Drawings should show barrier features and specifications in critical areas
Must be an effective barrier for minimizing the passage of microorganisms
Stakeholders
3Entity submitting development data and knowledge; Entity performing the work process for change
Entities submitting data to FDA for device clearance
Entity responsible for submitting NDINs
Regulatory Context
Attributes
2Quality parameter that must remain unchanged for the policy
Standard for 510(k) clearance
Identified Hazards
Hazards
1Risk that surgical apparel is intended to protect against.; Risk that surgical apparel is intended to prevent.
Related CFR Sections (4)
- 21CFR862.9§ 862.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the casRead full regulation →
- 21CFR878.4040§ 878.4040 Surgical apparel.
(a) Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgicalRead full regulation →
- 21CFR878.4370§ 878.4370 Surgical drape and drape accessories.
(a) Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector thaRead 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 →
Related Warning Letters (2)
- 2023-11-14
CGMP/QSR/Medical Devices/Misbranded
Wello Inc.
- 2023-02-14
CGMP/QSR/Medical Devices/PMA/Adulterated
Wintech Medipro LLC
See Also (8)
- The Least Burdensome Provisions: Concept and Principles: Guidance for Industry and FDA Staff (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)
- CPG Sec. 391.200 Warning Statement in Advertisements for High-Intensity Mercury Vapor Discharge Lamps that are not Self-Extinguishing (21 CFR 1040.30(e)(3)*) (Status: Final)
- CPG Sec. 390.425 Records and Reports; Applicability - 21 CFR 1002.1 (Status: Final)
- Testing Guidance for Male Condoms Made From New Material (Non-Latex) (Status: Final)
- Addendum to: Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities (Status: Final)
- Thermal Endometrial Ablation Devices (Submission Guidance for an IDE) (Status: Final)