Through the development phase you have planned, designed, verified/validated your product and then carefully designed and implemented your manufacturing processes. Your product begins commercial use and nothing should go wrong………right? I think we have all heard the classic phrase "the best laid plans of mice and men often go astray". This applies equally in the medical product world. Either you don’t anticipate everything that may occur in the real life application of your product (e.g., user training, human factors, drug interactions, off-label use, short-term vs long-term use, larger patient population demographics, etc.) or at a minimum you find ways (designs/manufacturing) to improve upon your product. If a company has a robust Customer Feedback/Post Market Surveillance Process, a strong Corrective and Preventative Action (CAPA) Process and a responsive Design Control Process, they can respond efficiently and effectively while gaining customer loyalty.
The challenge can often be that design changes must be reviewed to determine if regulatory filings are required. In the pharmaceutical world, the decision is more tightly regulated. When approved through an NDA, a drug specification is locked down along with its manufacturing process (including testing methodology). Changes are allowable but the range of changes are significantly more narrow than what might be seen in the medical device world (refer to FDA guidance - Changes to an Approved NDA or ANDA) even when you compare to class III medical devices approved via a PMA (refer to FDA guidance - Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process). For class II and a very limited number of class III medical devices design changes that do not require a new 510(k) submission is much broader.
Due to the vague language in regulation on design changes to class II and a limited number of class III devices, companies are often challenged to make the “correct” decision. If the wrong decision is made, a company can have product shipments stopped overnight and worst, if a adverse event profile has created a concern for safety or there are indications for use outside of FDA clearance, a recall may be required. Additionally, a company may be forced to communicate with their customers or the general product that their device is not on the market legally. None of these outcomes is positive.
We recommend for changes that are in the “grey” area that you have an independent assessment to confirm and potentially bolster your decision not to submit a 510(k). RQMIS consultants are former ODE reviewers that help support this activity. We standby our recommendations! For those changes that require a submission make sure you have a robust design control process that requires input as to the verification and validation testing requirements of FDA and Notified Bodies to assure a smoother submission process with the relevant third parties. Your thoughts on the “grey area” of when to file?
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