FDA Updates and Insights: Inspection of Medical Device Manufacturers
The new FDA Compliance Program for the Inspection of Medical Device Manufacturers and what it means to you.
The FDA just issued their updated compliance program for the Inspection of Medical Device Manufacturers, CP7382.845. This program is now in effect and will continue until it's completion date of September 30, 2004.
If you are not familiar with FDA internal documents, the FDA has to have a plan for how the field offices are to perform their tasks. The FDA's office of compliance prepares these programs which outline how they expect the field to operate. These programs are updated when new regulations are enacted or just after a period of time to make sure that the programs are still appropriate. (For more FDA Updates and Insights, click here).
This Compliance Program was issued Oct. 2000 but was just released to the field.
As is stated in the program's background, "This compliance program provides guidance to FDA field and center staffs for the inspections and administrative/enforcement activities related to the Quality System/Good Manufacturing practices (QS/GMP) regulations (21 CFR 820), the Medical Device Reporting (MDR) regulation (21 CFR 803), and the Medical Device Tracking regulation (21 CFR 821), the Corrections and Removals regulations (21 CFR 806), and the Registration and Listing regulation (21 CFR 807)."
The Program goes on to state, "This compliance program encompasses five regulations for inspecting medical device firms. Under the QS/GMP regulation, manufacturers are expected to control their products from "cradle to grave" meaning from design stage through prost-market surveillance. Manufacturing processes, such as sterilization, are required to be implemented under appropriate controls. The MDR, Tracking and Corrections and Removals regulations involved activities with which manufacturers and importers are required to comply after the devices are distributed. This compliance program provides specific guidance for each. It also requires coverage for the Registration & Listing regulations."
The FDA is keeping the QSIT inspection approach for the next three and half years. The only changes that are very how they are going to conduct these inspections to reduce inspection time.
The FDA will require that all Class III and Class II medical device manufacturers will be inspected under this guidance. There will be three inspection levels. Level 1 inspections are considered Abbreviated Inspections. Level 2 inspections are considered Baseline (Comprehensive) Inspections. Level 3 inspections are considered Compliance Follow-up Inspections.
The following is the manner in which the districts are to schedule inspections:
Priority A Manufacturer of High Risk and Class III Devices.
- Manufactures that have never been inspected.
- OAI (official Action Indicated) follow-up inspections.
- Manufacturers that received their last inspection more than two years ago.
- Any other manufacturer of high risk or Class III device.
- Establishments that are only specification developers or repackers/relabelers.
- Manufacturers of Class II devices that have never been inspected.
- OAI follow-up inspections.
- Manufacturers of Class II or I devices that have conducted more that two recalls in the last 12 months.
- Manufacturer of Class II or I devices that have recently experienced an increase in MDR reports.
- Manufacturers of Class II devices that have received 510(k) clearance notification(s) within the last two years.
- Another other manufacturer of Class II devices.
- Establishments that are only Class II specification developers or repackers/relabelers.
- Manufacturers of Class I devices that have never been inspected.
- Manufacturers of Class I sterile devices.
- Any other manufacturer of Class I devices.
The FDA is still maintaining the program of Pre-notification of Inspections. The evaluation of the pilot phase of the Medical Device Industry Initiatives (MDII) for pre-notification of inspections, annotated FDA-483s and Post Inspectional Notification Letters identified benefits to both industry and FDA. Thus, these programs will be made permanent.
The FDA will use the following inspectional strategy for conducting their inspections:
|
Inspection Level |
Reason for Inspection |
QSIT Subsystems Inspected |
|
1 |
Abbreviated |
CAPA plus one subsystem |
|
2 |
Baseline (Comprehensive) |
The Four Major Subsystem |
|
3 |
Compliance Follow-up |
As directed by inspection guidance |
An interesting fact, the FDA is moving closer to the similar ISO audits and surveillance audits with even more time between comprehensive inspections. For ISO audits the re-certification audit is supposed to be conducted every third year. Here the FDA is expecting that Baseline (Level 2) inspections be conducted at least every 6 years with the Abbreviated (Level 1) inspections being conducted in the in-between years. This is of course if the district resources permit.
Please be aware that the FDA is not reducing their issuance of FDA 483s or even Warning Letters. The FDA will use the following statement to open each FDA 483 issued:
The observations noted in this form FDA 483 are not an exhaustive listing of objectionable conditions. Under the law, your firm is responsible for conducting internal self-audits to identify and correct any and all violations of the quality system requirements.
The FDA will also be inspecting for the use of Electronic Records and Signatures.
All Foreign inspections should also be conducted using the QSIT format and at the appropriate inspection level as defined by the inspection assignment.
Please note: That the failure of foreign device manufacturers to register and to list products exported to the US will subject medical devices to detention upon entry.
This FDA compliance program also has several new areas or concern. They are to the companies that Remarketed Devices (Remanufacturers of Used Devices), Third Party Refurbishers/Reconditioners/Services of Used Devices and finally Reprocessors of Single Use Devices.
The Compliance program addresses each of these areas and what is expected of them to assure compliance.
You should also be aware that the FDA is expecting all companies to verify that their medical device listings are up to date every six months. If you are not doing this, or if you had not updated your registration at least every two years then these observations would be noted in the investigator's report but these observations would not be listed on the FDA 483.
So, it would appear that the FDA is still trying to maintain their level of surveillance on the medical device industry but budget restraints are limiting the FDA's activities. The amount of time that an investigator would spend in your facilities would also be limited according to this program. But, do not get a false sense of security. The FDA will not abandon their mission to protect the public. If they feel that you are into in QS/GMP compliance, I will tell you that they will relentless in making sure that they fully document their case.
The area that a company will most importantly have to understand and implement is the CAPA section of the QS/GMP. I have also found that this is one of the areas most mishandled. Most companies do not understand how to apply CAPA or at least do not have to do route cause analysis. Also, most companies are not applying the PA or Preventative Action part of the CAPA. This is an area that companies need to work on.
Quality data, that includes all quality date review along with management review will be critical to pass any FDA audit under this compliance program.
You could down load a copy of this compliance program from the FDA's website at www.fda.gov or from mdi's offices for a small copying and mailing charge.
Alan Schwartz, mdi Consultants, Inc., Great Neck, NY, has been providing strategic planning on FDA regulatory compliance issues since 1978. Prior to mdi, Alan was a Supervisor of field operations for the US FDA. Mr. Schwartz has worked with the FDA regulated industry worldwide with clients in India, Pakistan, Japan, Korea, Taiwan, Germany, Italy, Argentina and Brazil. He has written articles on dealing with the FDA and does a monthly Insight Report which could be found at mdi's website. His experience in dealing with FDA inspections, prior to, during and after the FDA Investigator has left, is extensive. He has participated in over 400 FDA inspections assisting companies understand the FDA strategy, preparing replies to the FDA 483 and Warning Letters and acting as a third party certification under FDA approval. Mr. Schwartz also is an Internationally Certified Lead Assessor for ISO9000 and is on the editorial advisory board of the Institute of Validation Technology.
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