Step by Step: FDA Cracks Down on Unauthorized Medical Device Modifications

The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical device (i.e., 510(k)).¹ With a nod to the late Eddie Rabbitt’s 1981 hit, “Step by Step,” medical device companies often modify products, step by step, for lifecycle management purposes and to sell next-generation products. However, when those modifications fall outside the scope of an existing clearance, FDA can take action if it believes the changes require a new marketing submission. The recent Warning Letter highlights a critical aspect of medical device regulation: while a device may initially be cleared through the 510(k) process, subsequent changes that could significantly affect safety or effectiveness or be a major change in intended use can trigger significant regulatory scrutiny. Companies must conduct robust risk-based assessments to determine whether modifications require a new 510(k) submission or other regulatory authorization.

Background

• FDA conducted an inspection of the firm and found the modifications.
• The device in question originally received FDA clearance through the 510(k) process.
• The cleared indications for use specified that the device was intended for a specific medical procedure within a defined timeframe.
• The manufacturer implemented a design modification involving a change to the device’s physical characteristics, a feature not included in the original 510(k).
• This prompted FDA to classify the device as “adulterated,” as it lacked an approved premarket approval (“PMA”) application or an investigational device exemption (“IDE”) for the modified device.
• In addition, the device was deemed “misbranded” due to the absence of a new 510(k) notification reflecting the design change.

FDA Guidance on Device Modifications

• FDA’s guidance document, “Deciding When to Submit a 510(k) for a Change to an Existing Device,” outlines that significant modifications — those that could significantly affect the device’s safety or effectiveness — necessitate a new 510(k) submission.²
• Manufacturers must conduct a risk-based assessment to determine if a change requires a new submission.
• In this case, the agency concluded that the design modification changed the device’s physical characteristics and, therefore, required a new 510(k) submission due to its potential effect on the device’s performance.
  • FDA noted that certain technological characteristics were not recorded in the 510(k).

AGG Observations

• The Warning Letter serves as a reminder that a company must review each modification to determine whether it could significantly affect the safety or efficacy of the product or result in a major change in intended use.
• The agency discovered the issue through an inspection; there is no specific indication that FDA received a competitor trade complaint. FDA can learn of non-compliance in a number of ways.
• Companies should review the applicable regulation (21 C.F.R. § 807.81) and FDA’s guidance document to determine if a new 510(k) submission is required.
• If a company concludes that a new 510(k) submission is not required, it should prepare an internal memo to file to explain the rationale in case questioned later by FDA.

Many minor changes can ultimately result in a significant change to safety or efficacy or major change in intended use. Step by step. Review carefully each modification.

[1] The Warning Letter can be accessed here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/qapel-medical-inc-699244-02052025.

[2] U.S. Food & Drug Admin., Deciding When to Submit a 510(k) for a Change to an Existing Device (Oct. 25, 2017), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device.