Company: Avidcare
WL Date: 4/17/01
Product: In home Asthma Monitoring System
…”Under a United States Federal law, the Federal Food, Drug and Cosmetic Act (the Act), these products are considered to be medical devices because they are used to diagnose or treat a medical condition or to affect the structure or function of the body. Home Health Monitoring Systems and their associated software are medical devices as defined by Section 201(h) of the Act.
Your firm is manufacturing and marketing a Model SP-20 Asthma Monitoring System which uses spirometry for in-home monitoring of asthma. That device does not have a 510(k) pre-market clearance or pre-market approval.
During the September 12-29, 2000, inspection you claimed to be exempt from pre- market requirements because the device is the subject of an investigational study conducted by _____ and _____ Based on the information provided to our investigators during the inspection, it did not appear that this study formed a valid basis for exemption because the requirements for Investigational Device Exemptions (Title 21, Code of Federal Regulations, Part 812 [21 CFR 812]) have not been met. Investigations conducted at _____ and _____ verified that the SP-20 Asthma Monitoring System is not exempt from pre-market requirements.
Therefore, the Model SP-20 Asthma Monitoring System (including the home monitor, clinical station and associated software) is adulterated within the meaning of Section 501(f)(1)(B) of the Act in that they are Class III devices under Section 513(f) and do not have an approved application for pre-market approval in effect pursuant to Section 515(a) or an approved application for an Investigational Device Exemption under Section 520(g).
The SP-20 Asthma Monitoring system is also misbranded within the meaning of Section 502(o) of the Act in that a notice or other information respecting the modification and new intended use of the device was not provided to the FDA as required by Section 510(k) and 21 CFR 807.81(a)(3)(i) and (ii).
Our inspection also found that your devices are adulterated within the meaning of Section 501(h) of the Act in that the methods used in, facilities or controls used for manufacturing, packing, storage or installation of the medical devices are not in conformance with the Good Manufacturing Practices (GMP) requirements set forth in the Quality System Regulations for Medical Devices as prescribed by 21 CFR 820.
GMP violations that were observed during the September 12-29, 2000, inspection include:
1. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified requirements are met (21 CFR 820.30). For example, software version 1.18 was not implemented through an Engineering Change Order, and the software was not validated.
2. Failure to establish and maintain procedures for implementing corrective and preventive action (21 CFR 820.100). For example, a recall was conducted without following established procedures.
3. Failure to maintain a complete Device Master Record (21 CFR 820.181). For example, the Remote Programming Function is not included in the functional requirement specifications.
4. Failure to develop, conduct, control and monitor production processes to ensure that devices conform to specifications (21 CFR 820.70). There is no procedure to define and control the use of remote programming.
5. Failure to conduct quality audits to assure that the quality system is in compliance with requirements (21 CFR 820.22). There are no records that quality audits have been conducted.
6. Failure to establish and maintain procedures for control and distribution of finished devices to ensure that only those devices approved for release are distributed (21 CFR 820.160). Packing lists and shipping documents erroneously indicate that products have been shipped when, in fact, they have not been shipped.
7. Failure to establish and maintain procedures to control labeling (21 CFR 820.120). No written procedures exist to assure that only properly released labeling is shipped with devices.
FDA District: Minneapolis
