Company D - Q and A.pdf
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- Attached to
- DEPARTMENT FO VETERANS AFFAIRS - POSITIVE AIRWAY PRESSURE DEVICES AND ACCESSORIES RECOMPETE
- Solicitation number
- 36C79125Q0029-0001
About this file
This document appears to be a Question and Answer (Q&A) document regarding FDA regulatory requirements for mask liners and interfaces in a positive airway pressure delivery system. The key points are:
The document discusses technical requirements for medical devices, specifically addressing two main concerns: FDA 510K Standard compliance and material composition for mask liners. The regulatory guidance indicates that while mask liners may not require full FDA 510K approval, all patient-contacting components must be demonstrated to be biocompatible. The document references the Federal Register for Medical Devices and specifically Part 868 for Anesthesiology Devices, which classifies positive airway pressure delivery systems as Class II (special controls) devices. The key regulatory requirement emphasized is that all patient-contacting components must be proven biocompatible, regardless of whether they are considered a primary device or an accessory.
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| Company F - Q and A.pdf | ||
| Company E - Q and A.pdf | ||
| Company B - Q and A.pdf |
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Text version
1. Concerning the following statement:
1. Offerors will submit documentation that products meet or exceed United States FDA 510K Standard (“FDA Standard”).
Q. Mask Liners do not require any FDA or 510K approval since there are no claims that affect the function or safety of the PAP system itself or claims that it improves therapy efficacy. Also, this is an accessory vs a device, so 510k clearance is not required.
A. The need for mask liners to be FDA cleared or 510 approved can be reconsidered where applicable.
2. Concerning the following statement:
4) Materials: All materials used for the construction of interfaces must be independently certified as being medical grade, hypoallergenic substances, free from impurities which may cause allergic reaction. There must be confirmation of biocompatibility and toxicological safety for all product parts which come into contact with the skin or the mucosa by an independent testing institution. All materials must be latex-free
Q. This appears to be a minimum technical requirement for an Interface CLIN 0008(we noticed CLIN 0008 was a typo in the Mask Liner section and "interface" was listed in this statment) as these type of requirements are more typical for a CPAP Interface and not a mask liner. "Hypoallergenic substances, free from impurities which may cause allergic reaction" is a statement that does make sense. These are simple comfort accessories that do not require third party testing for biocompatibility and toxicological safety. Can the latex statement be changed to all material touching the skin must be latex-free?
A. Per the Federal register for Medical Devices; Anesthesiolgy Devices; Classification of the Positive Airway Pressure Delivery System, all components that touch the patient must be demonstrated to be biocompatible.
FDA and 510 approval will not be required for mask liners.
List of Subjects in 21 CFR Part 868
PART 868—ANESTHESIOLOGY DEVICES
1. The authority citation for part 868 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
2. Add § 868.5273 to subpart F to read as follows:
§ 868.5273 https://www.ecfr.gov/current/title-21/part-868 https://www.govinfo.gov/link/uscode/21/351 https://www.govinfo.gov/link/uscode/21/360 https://www.govinfo.gov/link/uscode/21/360c https://www.govinfo.gov/link/uscode/21/360e https://www.govinfo.gov/link/uscode/21/360j https://www.govinfo.gov/link/uscode/21/360
Positive airway pressure delivery system.
(a) Identification. A positive airway pressure delivery system is a prescription noninvasive ventilatory device that delivers expiratory positive airway pressure for patients suffering from obstructive sleep apnea. The system also provides positive airway pressure during incipient apnea. The system may include a dedicated flow generator and a patient interface.
(b) Classification. Class II (special controls). The special controls for this device are:
(1) The patient-contacting components of the device must be demonstrated to be biocompatible.
PART 868—ANESTHESIOLOGY DEVICES
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