FDA pro­vides rig­or­ous over­sight of med­i­cal de­vices

Modern Healthcare - - Comment -

The Jan. 25 ed­i­to­rial “Left to their own de­vices” (p. 26) re­gret­tably pro­vides an in­ac­cu­rate de­pic­tion of the safety of med­i­cal de­vices and the Food and Drug Ad­min­is­tra­tion’s reg­u­la­tory process.

The col­umn con­demns the FDA for not re­quir­ing clin­i­cal trial test­ing for all new med­i­cal de­vices as the agency does for drugs. But de­vices and drugs are fun­da­men­tally dif­fer­ent, and there is no rea­son they should be reg­u­lated or eval­u­ated the same way.

Med­i­cal tech­nol­ogy en­com­passes ev­ery­thing from tongue de­pres­sors to brain stim­u­la­tors. The FDA tar­gets the amount of ev­i­dence re­quired to prove safety and ef­fec­tive­ness to the risk of the de­vice.

For the new­est, high­est-risk de­vices, the FDA does re­quire clin­i­cal trial test­ing sim­i­lar to phar­ma­ceu­ti­cals. For low­er­risk de­vices, com­pa­nies sub­mit hun­dreds—some­times thou­sands— of pages of sci­en­tific ev­i­dence cov­er­ing bench test­ing, an­i­mal stud­ies, bio­com­pat­i­bil­ity test­ing, etc., that FDA re­views to de­ter­mine safety and ef­fec­tive­ness.

There is no prece­dent—no stud­ies, no literature—that shows hu­man tri­als pro­duce safer de­vices when those de­vices have al­ready un­der­gone such rig­or­ous pre­mar­ket test­ing.

As science and tech­nol­ogy evolve, so does the reg­u­la­tory sys­tem. This in­dus­try has and will con­tinue to en­gage with all stake­hold­ers on process im­prove­ments. But to ig­nore the mil­lions of peo­ple over the decades who have ben­e­fited from med­i­cal tech­nol­ogy thanks to the FDA’s rig­or­ous over­sight and in­dus­try’s com­mit­ment to safety does a dis­ser­vice to the pa­tients we serve.

Scott Whi­taker Pres­i­dent and CEO

Ad­vaMed Wash­ing­ton, D.C.

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