Dr. D is starting to see a whole bunch of virtual device companies hanging out their shingles and jumping feet first into the medical device industry. In fact, the doctor really enjoys the opportunities associated with providing consulting services to these new companies. In some cases, these new virtual organizations may be “acephalous” (look-it-up), with the collective powers of the organization being shared. However, there are regulatory and quality risks associated with starting a virtual company. It is acceptable to outsource quality and regulatory activities, not unlike outsourcing manufacturing operations to a contract manufacturer. But companies cannot outsource their quality and regulatory responsibilities, which are considered statutory by FDA and regulators outside of the United States.
Simply stated, if the product label contains your organization’s name and your organization owns the regulatory filing, your organization owns the quality and regulatory responsibilities associated with the design, development, manufacturing, regulatory approvals prior to entering the product into commerce, and post-market surveillance activities (i.e., MDRs, Vigilance Reporting, etc.). If you don’t believe Dr. D, just ask the FDA or your notified body about the ownership of these critical responsibilities.
The outsourcing of manufacturing, metrology services, product sterilization, and supplier audits have been considered common practice in the device industry for years. In recent years, the outsourcing of internal audits, the preparation of 510(k)s, PMAs, Technical Files, and Design Dossiers, and the management of product recalls have become common practice.
Question – Can you guess what all of these outsourcing activities have in common?
- Outsourcing of salient processes can save organizations time and money.
- If an organization outsources a product or service, they are not responsible for the outcome.
- Organizations own the quality and regulatory responsibility, regardless of outsourcing.
- None of the above.
- A and C.
If you answered ‘e’, you would be correct. However, select the wrong supplier or fail to qualify a supplier, contractor, or consultant; and instead of saving money, cash will start flowing out the organization at a rapid pace. The phrase, “Throwing good money after bad,” comes to mind.
FDA Warning Letter – Dated 11 December 2013
The doctor was able to find a recent agency warning letter that highlights the reliance on the outsourcing of services deemed critical by FDA and depicted in the QSR. Remember, outsourcing is not the problem. The lack of oversight and the need to own the quality and regulatory responsibilities is the problem.
For this week’s guidance, the doctor will leave the readers with just one takeaway. It is acceptable to outsource just about every conceivable activity associated with medical device manufacturing. However, organizations can never outsource their quality and regulatory responsibilities. Failure to recognize and assume ownership and the wrath of our friends from the agency will be swift and painful.
In closing, thank you, thank you, and thank you again for joining Dr. D and I hope you find value in the guidance provided. Until the next installment of DG – cheers from Dr. D. and best wishes for continued professional success.
- Code of Federal Regulation. (2013, April). Title 21 Part 820: Quality system regulation. Washington, D.C.: U. S. Government Printing Office.
- Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
- Warning Letters – Inspections, Compliance, Enforcement, and Criminal Investigations. (2013, December). Retrieved January 26, 2014, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm379529.htm