Are you making these mistakes with FDA 21 CFR PART 820 made for medical devices

 Manufacturers are expected to follow the quality system requirements described in FDA 21 CFR part 820This document guides to govern the design, manufacture, packaging, labelling, storage, installation, and servicing of medical devices intended for human use. The requirements in 21 CFR Part 820 are meant to ensure the safety and efficacy of medical devices sold in the US marketplace.

FDA conducts regular inspections of medical device manufacturers to ensure compliance with these regulations. The inspection process, known as the Quality System Inspection Technique (QSIT), evaluates a company’s internal quality processes to determine whether they are in alignment with or in violation of these regulatory requirements. If any violations are discovered, the inspecting agent from FDA will issue in the form of 483 Inspectional Observations, Warning Letters what is applicable

 

Here are the most common mistakes companies run into with FDA 21 CFR Part 820:

1.  CAPA Procedures and 21 CFR Part 820.100(a) CAPA not followed adequately and repeat failure is detected

2.  Complaint Handling and CFR Part 820.198(a) Parameters described in procedure are not fulfilled and closure is not timely and adequate.

3.  Nonconforming Product and CFR Part 820.90(a) Investigation is not proper, CAPA is not applied conclusion is not enough, preventive action is not proper, repeat failure is detected.

4.  Purchasing Controls and CFR Part 820.50 control for specification and artwork s not controlled purchase found with old label artwork and specification. PO does not mention specification or art- work reference

5.  Process Validation and CFR Part 820.75 System is not adequate, not followed, re-validation where defined is not done or done late, changes are not captured in validation. Protocols are not properly and timely approved before starting activities.

6.  Quality Audit and CFR Part 820.22 Audit done randomly, annual plan is not available, Audit closer is not proper, audit compliance are not reviewed in Management review meeting.

7.  Device History Records and CFR Part 820.184 Incomplete, completed in hurry just before audit, quality and regulatory are not in full control of DHR.

8.  Design Validation and CFR Part 820.30(g) Protocol is not adequate; all aspects of validation are not covered. Documentation is not proper.

9 PMS (post marketing surveillance) System is not followed. Some reportable incidents are not informed to FDA. Some critical or major complaints related to product not covered in PMS

10 UDI (Unique Device Identification) system documentation and records are poorly maintained.

11. Production, process control and quality control and assurance: System inadequate, documentation is not timely, and records are filled late or improper. Critical values are not verified by another independent person.

 

IZiel adopts an analytical mindset thus enabling us to root out all possible non-conformances in a regulatory submission. IZiel works in collaboration with your team to develop the complete Design History File (DHF) including requirements management, risk management, process validations and software validations using robust design controls process and quality system procedures. Thereafter, IZiel team works with their regulatory team in USA to complete the submissions (510k or PMA) for USFDA Approvals.