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Best Practices for Establishing a Compliant Medical Device and Complaint Handling System
All medical device manufacturers are required to comply with the complaint handling requirements and medical device reporting (MDR) pursuant to the applicable statutes and regulations.
This webinar is intended to help you get familiar with the best practices for the medical device complaint handling system. This webinar is also intended to provide guidance on how to meet the regulatory requirements for handling any complaints concerning all medical device types.
Question And Answers
1. What is the flexibility of Quality System Regulations (QSR) requirements according to section 21 CFR 820.5?
- 21 CFR 820.5 requires Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured, and that meets the requirements of this part.
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2. What are the general objectives of section 21 CFR Part 820 QSR?
- The QSR specifies general objectives such as use of trained employees, design reviews, design validation, calibrated equipment, process controls, etc., rather than methods, because a specific method would not be appropriate to all operations. In some cases, however, the QSR does specify the particular type of method to be used, such as written procedures or written instructions.
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3. Where is the QSR applied?
- The QSR applies to finished devices intended to be commercially distributed for human use unless there is an approved exemption in effect.
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4. What is the meaning of Finished Device according to FDA?
- Finished device means any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.
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5. What is the meaning of Manufacturer?
- Manufacturer means any person who designs, manufactures, fabricates, assembles, or processes a finished device. Manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development and initial distributors of foreign entities performing these functions.
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6. What is the meaning of Adverse Event according to FDA?
- Adverse event means any incident where the use of a medication (drug or biologic, including human cell, tissue, or cellular or tissue-based product (HCT/P), at any dose, or a medical device (including in vitro diagnostics) is suspected to have resulted in an adverse outcome in a patient.
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7. How the the Initial Review and Evaluation of the Complaints interpretated?
- Section 820.198(b) discusses the initial review and evaluation of the complaints in order to determine if the complaints are "valid." This evaluation is not the same as a complaint investigation. It is important to note that this evaluation is not the same as a complaint investigation. The evaluation is performed to determine whether the information is truly a complaint or not and to determine whether the complaint needs to be investigated or not. If the evaluation decision is not to investigate, the justification must be recorded.
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8. What should be done by the manufacturer if he cannot obtain the information described in 820.198(e)?
- If the information described in section 820.198(e) cannot be obtained, then the manufacturer should document the situation and explain the efforts made to ascertain the information. This will be considered to be acceptable as long as a reasonable and good faith effort was made.
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9. What does the section21 CFR 820.198 (e) of Complaint Files says about Accessibility to the Investigated Complaints and the Records?
- When the manufacturer's formally designated complaint unit is located at a site separate from the manufacturing establishment, the investigated complaint(s) and the record(s) of investigation shall be reasonably accessible to the manufacturing establishment.
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10. What is the Record Retention Period for Complaint Files according to section 21 CFR 820.180(b)?
- All records (complaint files) required by this part shall be retained for a period of time equivalent to the design and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution by the manufacturer.
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