The FDA 510(k) was changed — what do Medtech com­pa­nies need to know?

The main path­ways Euro­pean Medtech com­pa­nies use to enter the U.S. mar­ket was changed in June 2026. Innokas QA/RA spe­cial­ist, Min­na Esko­la, com­ments on this change.

The FDA 510(k) is one of the pri­ma­ry reg­u­la­to­ry path­ways for bring­ing med­ical devices to the U.S. mar­ket. It is a pre­mar­ket noti­fi­ca­tion process in which a man­u­fac­tur­er demon­strates that its device is “sub­stan­tial­ly equiv­a­lent” to an already legal­ly mar­ket­ed device, known as a pred­i­cate.

This approach allows many mod­er­ate-risk (typ­i­cal­ly Class II) devices to reach the mar­ket with­out exten­sive clin­i­cal tri­als, mak­ing it faster and often less bur­den­some than more rig­or­ous approval routes. The empha­sis isn’t on prov­ing safe­ty from scratch, but on show­ing that the new device per­forms cor­re­spond­ing­ly as some­thing already approved.

Why it’s rel­e­vant for Euro­pean Medtech com­pa­nies

The 510(k) is not a require­ment with­in Europe. In the EU, devices are approved under the Med­ical Device Reg­u­la­tion (MDR) and must obtain a CE mark to be sold across the Euro­pean Eco­nom­ic Area. How­ev­er, Euro­pean com­pa­nies fre­quent­ly use the 510(k) path­way to access the U.S. mar­ket, as it is one of the world’s largest and most com­mer­cial­ly impor­tant health­care mar­kets. Many glob­al Medtech com­pa­nies enter both path­ways, MDR com­pli­ance for Europe and 510(k) clear­ance for the U.S., as part of a broad­er inter­na­tion­al mar­ket strat­e­gy. “It should be not­ed that the com­pa­nies are not the sole deciders; the path­ways are deter­mined main­ly based on the qual­i­ties of the device,” Min­na reminds.

It’s also impor­tant to note that clear­ance in either the Euro­pean or U.S. mar­ket does not auto­mat­i­cal­ly trans­late to suc­cess­ful entry in both. The EU MDR often requires more exten­sive clin­i­cal evi­dence, stricter doc­u­men­ta­tion, and ongo­ing post-mar­ket sur­veil­lance com­pared to the 510(k) path­way. As a result, Euro­pean man­u­fac­tur­ers may find the U.S. path­way com­par­a­tive­ly more pre­dictable than MDR com­pli­ance and CE mark acqui­si­tion, but not always. “Find­ing the right pred­i­cates is often more work than antic­i­pat­ed,” Min­na notes.

What changed in June 2026

In June 2026, FDA updat­ed its device exemp­tion guid­ance for the first time since 2019. In this update, the list of device types that no longer require a 510(k) sub­mis­sion was expand­ed. The update adds sev­er­al prod­uct codes cov­er­ing well-char­ac­ter­ized, low-risk tech­nolo­gies as 510(k) exempt, fur­ther build­ing on the agen­cy’s exist­ing exemp­tion list.

This reflects a broad­er shift toward risk-based approach on the mar­ket entry, where reg­u­la­to­ry effort is con­cen­trat­ed on high­er-risk tech­nolo­gies while sim­pler, low­er-risk devices face less admin­is­tra­tive bur­den.

In the mean­while, FDA con­tin­ues their long run effort to clar­i­fy the selec­tion and use of pred­i­cate devices in 510(k) sub­mis­sions, aim­ing for valid and cur­rent equiv­a­lence deter­mi­na­tions as device tech­nol­o­gy evolves. This isn’t new to June 2026 but remains a part of the same broad­er push toward a more risk-opti­mized 510(k) pro­gram.

What does this mean for mar­ket strat­e­gy?

The 510(k) path­way remains a cor­ner­stone of U.S. mar­ket access, but it is evolv­ing, and not always in the direc­tion of more paper­work. “Man­u­fac­tur­ers con­sid­er­ing a dual strat­e­gy cov­er­ing both MDR and FDA require­ments should review their prod­ucts against the FDA’s June 2026 exemp­tion expan­sion. Some devices that pre­vi­ous­ly required a 510(k) sub­mis­sion no longer need one,” Min­na advis­es.

“If a device is 510(k) exempt, a com­pa­ny may have a stronger base to enter the U.S. mar­ket first and use the rev­enue gen­er­at­ed there to help fund MDR com­pli­ance costs before expand­ing into the EU,” Min­na says. “How­ev­er, this doesn’t reduce the work required to meet MDR require­ments, and 510(k) exempt devices must still com­ply with the FDA’s gen­er­al con­trols to be sold in the U.S.”

Under­stand­ing these changes is essen­tial for opti­miz­ing costs and resources and plan­ning a glob­al mar­ket entry strat­e­gy in an increas­ing­ly risk-based reg­u­la­to­ry land­scape.

If you are look­ing for expert guid­ance on nav­i­gat­ing mar­ket entries and approval process­es, Innokas qual­i­ty and reg­u­la­to­ry team would be hap­py to plan the steps with you. 

Source (text and image): Innokas (based on an inter­view with Min­na Esko­la)