On 22 February 2013, the Food and Drug Administration's (FDA or "the agency") Center for Devices and Radiological Health (CDRH) issued a draft guidance titled, Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements - Draft Guidance for Industry and Food and Drug Administration Staff, which describes how to differentiate violative devices from non-violative devices with respect to Corrections and Removals (21 C.F.R. Part 806), as well as Voluntary Recalls (21 C.F.R. Part 7). The purpose of the guidance is to clarify when a change to a device constitutes a medical device recall, to distinguish those instances from product enhancements that do not meet the definition of a medical device recall, and to identify the associated regulatory reporting requirements for each type of activity.

The guidance does not address when changes to marketed devices trigger new product submissions. In addition, the guidance does not address issues regarding radiological health devices concerning radiation defects or failures to comply with radiation safety performance standards described in 21 C.F.R. Parts 1020-1050.

The document is organized into seven (7) sections, including definitions, recall identification, differentiating violative devices from non-violative devices, and recall and product enhancement reporting requirements. The guidance provides a question-and-answer format, which includes answers to FDA questions that the agency believes could be helpful to companies in properly identifying medical device recalls. Also, the guidance provides a Recall Decision Making Flow Chart, which is intended to assist companies in making an assessment for each proposed change to its device.

Correctly categorizing a change to a device as a recall or product enhancement impacts the applicability and nature of industry responsibilities and FDA oversight, as described in 21 C.F.R. Part 7, Subpart C- Recalls (Including Product Corrections)--Guidance on Policy, Procedures, and Industry Responsibilities.

Product enhancement defined

FDA’s regulations do not define product enhancement; however, the guidance document defines it as a change or improvement to a non-violative device as part of continuous device improvement activities. For example, product enhancements include, but are not limited to the following:

  • changes designed to better meet the needs of the user;
  • changes to make the product easier to manufacture; and
  • changes to the appearance of the device that do not affect its use.

A product enhancement is both 1) a change to improve the performance or quality of a device, and 2) not a change to remedy a violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) caused by the device. The guidance reiterates that a product enhancement is not a medical device recall. Presumptively, by emphasizing that product enhancements are for non-violative devices, a product enhancement could not be used to address a safety-related device issue.

Recall identification

The guidance provides a series of Q&As intended to guide industry in determining if the proposed change in the device should be considered a recall or product enhancement. The guidance instructs companies to determine the reason for a proposed change to the device, which includes but is not limited to the following:

  • the device design;
  • the manufacturing process;
  • the device labeling (e.g., updating the labeling of a distributed product); and
  • marketing practices (e.g., a removal of the device from the field).

The distinction between a recall and product enhancement depends on an assessment of each change individually, as well as the impact of all such changes on the device as a whole. If any change or group of changes addresses a violation of the FD&C Act, then that change would generally constitute a medical device recall.

Differentiating violative devices from non-violative devices

The document includes a section with a series of Q&As that assist device companies in determining if the device change(s) is being considered to correct a device failing to meet a specification(s) or failing to perform as intended, which would generally be considered by FDA as a violative situation that could initiate recall. On the other hand, a change to improve the performance or quality of a legally marketed, non-violative device could be considered a product enhancement and not a medical device recall.

Recall reporting requirements

This section of the guidance basically provides instructions for performing a recall as described in 21 C.F.R. Part 806, including definitions of Class I, II and III recalls and factors to consider in performing a thorough Health Hazard Evaluation (HHE), once a manufacturer determines that a proposed change meets the definition of a medical device recall. The series of Q&As in this section is intended to help companies process and submit the necessary documentation to FDA in accordance with the correction and removal regulation described above.

Product enhancement reporting requirements

The guidance explains that as long as a device manufacturer’s change or changes are initiated to reduce a risk to health posed by the device, “even if your change is not a recall” (line 417 of the draft guidance), FDA requires the company to submit an 806 report unless all the information has already been provided to FDA under the Medical Device Reporting (MDR) requirements (21 C.F.R. Part 803). The guidance goes on to provide some examples of changes that the agency would consider reportable under 806. In addition, the guidance explains that an 806 report submitted for product enhancements should be identified as such by the manufacturer. If FDA concurs that the change(s) is a product enhancement, the agency will not treat the report as a recall but will determine the appropriate premarket and postmarket actions necessary to address the information contained in the 806 report.

As drafted, this section appears to create ambiguity between Parts 7 and 806 of the regulations, and may differ from the FDA Recall Coordinators’ interpretations of what constitutes a recall. Specifically, Part 7 defines a recall as including “a firm’s removal or correction of a marketed product” (21 C.F.R. § 7.3(h)). Part 806 requires notifications for changes initiated to “reduce a risk to health” or “to remedy a violation … caused by the device that could present a risk to health” (21 C.F.R. § 806.10(a)(1) and (2)). Part 7 also indicates that notifications to users about safety related issues are “recalls” even when associated with “a situation in which use of, or exposure to, the violative product is not likely to cause adverse health consequences” (21 C.F.R. § 7.3(m)(3)). How a notice to users about a risk to health would not also be a recall (as suggested in the draft guidance) is not clear.

Potential areas of concern

The medical device industry should be aware of the potential risk that FDA may disagree about specific changes when seeking to characterize safety related improvements, corrections to labeling, or changes to a device’s design to address common adverse events as product enhancements, rather than as corrections. Given this risk, it will be important to see how narrowly FDA defines or, in practice, accepts or rejects a manufacturer’s characterization as to agreeing that the change is a product enhancement and not a recall situation.

Comments

The FDA has opened public dockets for comments on this draft guidance and will be accepting comments until 23 May 2013. Electronic comments on Docket No. FDA–2013–D–0114 can be submitted at www.regulations.gov. Written comments can be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.