Regulatory Open Forum

I suggest that the compliance/regulatory department's most important job is to accurately understand, and plan accordingly, for what FDA (by way of U.S. law) thinks and believes.  My experience, and FDA apparently is agrees, is that foreign manufacturers and the stateside importer(s) often don't have a close business relationship.  For example, time and again I've seen where foreign manufacturers rapidly connect with any number of initial importers to facilitate faster introduction of their products into the U.S.  As concerning as that may be, it's reality.

Accordingly, U.S. medical device law and FDA (via its promulgated regulations based on the law) have retained its stance on the separate reporting obligations for importers as distinguished from manufacturers.  Here are various statements [emphasis added by me] from FDA when it promulgated its regulations on this matter, and responding to concerns that many stakeholders I'm sure share:

• "...Who Shall Report...Although manufacturers and importers would be subject to identical reporting requirements...each has been separately defined to clarify that both would be required to report..."

• "...One comment suggests that a distributor be permitted to submit reports on behalf of a manufacturer with the manufacturer's consent...FDA disagrees with the comment. A manufacturer is ultimately responsible for its devices..."

• "...The rule applies equally to manufacturers and importers..."

• "...The final rule applies to all manufacturers and importers of marketed devices..."

• "...The Food and Drug Administration (FDA) is issuing a final rule that requires manufacturers and importers...to report to FDA..."

• "...The [importer complaint file] requirement also is necessary to enable FDA to determine whether...an importer is reporting when it receives or otherwise becomes aware of [reportable] information...Absent the complaint file requirement, FDA could-not be assured that device importers had fully complied with the [importer MDR reporting] requirements of the final rule..."

• "...Many comments on the 1980 proposal recommended that all device distributors [including importers] be exempt from reporting, primarily because manufacturers are more knowledgeable about their devices and are better equipped to evaluate potential device problems and hazards. Other comments stated that FDA would receive unnecessary multiple reports of the same incident if both manufacturers and distributors were required to report...FDA has carefully considered the comments...and has tentatively concluded [that this suggestion has merit] with one exception regarding importers...FDA is retaining...the requirement of the 1980 proposal that device importers report...for two reasons: (1) information concerning deaths or serious injuries and requests for correction involving an imported device will most likely be sent to the importer (as the first link in the chain of domestic distribution of a device), not to the foreign manufacturer; and (2) FDA has no authority to require foreign manufacturers to report device incidents to the agency..."

• "...If FDA is to be able to prevent or reduce deaths or serious injuries from devices...the agency needs to receive this information in a timely manner from all manufacturers and importers..."

In light of the FD&C Act's and FDA's underlying premises for the separate importer and manufacturer MDR requirements, I assert that it is imperative (to a firm's regulatory health and to public health) that the foreign manufacturer and initial importer clearly understand and distinguish their statutorily separate MDR reporting obligations, and then to approach MDR reporting accordingly.  It would be contrary to U.S. law if we were to think that a manufacturer's MDR report unilaterally fulfills the importer's separate MDR reporting obligation, or vice versa.  Such collaborative MDR reporting is only permitted by special exemption granted after applying to the FDA and demonstrating therein that the collaboration and parties can fulfill the separate intentions for importer MDR reporting vs. manufacturer MDR reporting.

I suggest that the compliance/regulatory department's most important job is to accurately understand, and plan accordingly, for what FDA (by way of U.S. law) thinks and believes.  My experience, and FDA apparently agrees, is that foreign manufacturers and the stateside importer(s) often don't have a close business relationship.  For example, time and again I've seen where foreign manufacturers rapidly connect with any number of initial importers to facilitate faster introduction of their products into the U.S.  As concerning as that may be, it's reality.

Accordingly, U.S. medical device law and FDA (via its promulgated regulations based on the law) have retained its stance on the separate reporting obligations for importers as distinguished from manufacturers.  Here are various statements [emphasis added by me] from FDA when it promulgated its regulations on this matter, and responding to concerns that many stakeholders I'm sure share:

• "...Who Shall Report...Although manufacturers and importers would be subject to identical reporting requirements...each has been separately defined to clarify that both would be required to report..."

• "...One comment suggests that a distributor be permitted to submit reports on behalf of a manufacturer with the manufacturer's consent...FDA disagrees with the comment. A manufacturer is ultimately responsible for its devices..."

• "...The rule applies equally to manufacturers and importers..."

• "...The final rule applies to all manufacturers and importers of marketed devices..."

• "...The Food and Drug Administration (FDA) is issuing a final rule that requires manufacturers and importers...to report to FDA..."

• "...The [importer complaint file] requirement also is necessary to enable FDA to determine whether...an importer is reporting when it receives or otherwise becomes aware of [reportable] information...Absent the complaint file requirement, FDA could-not be assured that device importers had fully complied with the [importer MDR reporting] requirements of the final rule..."

• "...Many comments on the 1980 proposal recommended that all device distributors [including importers]be exempt from reporting, primarily because manufacturers are more knowledgeable about their devices and are better equipped to evaluate potential device problems and hazards. Other comments stated that FDA would receive unnecessary multiple reports of the same incident if both manufacturers and distributors were required to report...FDA has carefully considered the comments...and has tentatively concluded [that this suggestion has merit] with one exception regarding importers...FDA is retaining...the requirement of the 1980 proposal that device importers report...for two reasons: (1) information concerning deaths or serious injuries and requests for correction involving an imported device will most likely be sent to the importer (as the first link in the chain of domestic distribution of a device), not to the foreign manufacturer; and (2) FDA has no authority to require foreign manufacturers to report device incidents to the agency..."

• "...If FDA is to be able to prevent or reduce deaths or serious injuries from devices...the agency needs to receive this information in a timely manner from all manufacturers and importers..."

In light of the FD&C Act's and FDA's underlying premises for the separate importer and manufacturer MDR requirements, I assert that it is imperative (to a firm's regulatory health and to public health) that the foreign manufacturer and initial importer clearly understand and distinguish their statutorily separate MDR reporting obligations, and then to approach MDR reporting accordingly.  It would be contrary to U.S. law if we were to think that a manufacturer's MDR report unilaterally fulfills the importer's separate MDR reporting obligation, or vice versa.  Such collaborative MDR reporting is only permitted by special exemption granted after applying to the FDA and demonstrating therein that the collaboration and parties can fulfill the separate intentions for importer MDR reporting vs. manufacturer MDR reporting.