FDA drafts guid­ance on Type V DMFs for com­bi­na­tion prod­ucts

The FDA on Mon­day is­sued draft guid­ance de­tail­ing when a Type V drug mas­ter file (DMF) can be used to pro­vide in­for­ma­tion about CDER-led com­bi­na­tion prod­ucts that in­clude a de­vice con­stituent that may be used in mul­ti­ple com­bi­na­tion prod­ucts.

DMFs are a vol­un­tary sub­mis­sion to the FDA of con­fi­den­tial in­for­ma­tion about cer­tain as­pects re­lat­ed to a drug or man­u­fac­tur­er. There are five types of DMFs, Type II-V (Type I DMFs were dis­con­tin­ued in 2000), with Type V DMFs cov­er­ing FDA ac­cept­ed ref­er­ence in­for­ma­tion that would not fit in the oth­er DMF types.

Specif­i­cal­ly, the FDA says the draft guid­ance ap­plies to CDER-led com­bi­na­tion prod­ucts that in­cor­po­rate a de­vice con­stituent with elec­tron­ic or soft­ware com­po­nents that per­form func­tions such as drug de­liv­ery; pro­vid­ing in­for­ma­tion used to make a de­ci­sion about a treat­ment or drug de­liv­ery; in­ter­face with oth­er de­vices or sys­tems to trans­mit in­for­ma­tion; or con­trol the prod­uct’s user in­ter­face.

The FDA notes that the guid­ance does not cov­er com­bi­na­tion prod­ucts where the de­vice con­stituent is a con­tain­er clo­sure sys­tem, as those may be sub­mit­ted as a Type III DMF.

“For such com­bi­na­tion prod­ucts, a Type V DMF can be an ef­fi­cient mech­a­nism to pro­vide in­for­ma­tion re­gard­ing the de­vice con­stituent part when the same in­for­ma­tion is ap­plic­a­ble to sev­er­al CDER ap­pli­ca­tions, and ad­di­tion­al mea­sures to en­sure con­sis­ten­cy are need­ed,” the FDA writes.

The FDA al­so notes that be­cause de­vice tech­nol­o­gy changes rapid­ly, mak­ing amend­ments to a Type V DMF is an ap­pro­pri­ate path­way for re­port­ing changes to the FDA for com­bi­na­tion prod­ucts.

The FDA ex­plains that once it re­views a Type V DMF for a de­vice, “its re­view may be ap­plic­a­ble to oth­er CDER ap­pli­ca­tions if the de­vice in­for­ma­tion re­mains un­changed and is per­ti­nent to oth­er CDER ap­pli­ca­tions that al­so in­cor­po­rate the DMF by ref­er­ence,” which the agency says would fa­cil­i­tate more ef­fi­cient and con­sis­tent re­views.

How­ev­er, the FDA notes that the guid­ance “does not ad­dress FDA pre­mar­ket re­view stan­dards or ex­pec­ta­tions” for de­vice con­stituents and that spon­sors should not sub­mit a Type V DMF to CDER if the same in­for­ma­tion is con­tained in a de­vice mas­ter file held by an­oth­er cen­ter at the agency.

The guid­ance al­so de­scribes the ad­min­is­tra­tive pro­ce­dure for sub­mit­ting and re­view­ing DMFs and makes rec­om­men­da­tions on the con­tent that should be in­clud­ed in Type V DMF sub­mis­sions, amend­ments and an­nu­al re­ports.

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