FDA 510 (k) Imréitithe nGLÉAS LASER CAILLTEANAS DON hair I MNÁ AGUS FIR: éifeachtúlachta nó Just SÁBHÁILTEACHTA?

Is é an (k) 510 aighneacht an phríomh-mheicníocht trína feistí leighis a ghlacfar ar an margadh i Stáit Aontaithe Mheiriceá. An FDA sonraí a éilíonn go n-éileamh ar ais coibhéis, sonraí tuairisciúil agus sonraí feidhmíochta chun tacú leis an gcineál seo aighneacht.

Tá misperception ginearálta go nglanann an FDA feistí leighis léasair agus le haghaidh margaíochta amháin bunaithe ar chruthúnas ar an tsábháilteacht. Ní hé sin an bonn tuisceana ceart i ngach cás, mar tá freisin anailís a rinneadh chun athbhreithniú a dhéanamh ar sonraí cliniciúla chun bunús na n-éileamh míochaine le haghaidh gléas nua.

The purpose of a 510k submission to the FDA is to demonstrate that a device is “substantially equivalent” to a predicate device  (one that has been FDA cleared or marketed before 1976).  The submission compares and contrasts the subject and predicate devices, explaining why any differences between them should be acceptable. While human data is not required for all 510(k), in many cases efficacy data from well-controlled clinical studies are required especially for new indications.  According to an official with the FDA, "Many of 510(k) submissions contain or require clinical data to demonstrate substantial equivalence”.  

There have been allegations that the 510(k) process for clearing new medical devices might be ‘cursory’.  In a letter to the N.Y. Times newspaper in November 2008, the Director of the Center for Devices and Radiological Health, FDA responded to this allegation as follows:

“……….under the congressionally established 510(k) process, the FDA often reviews laboratory and clinical data to substantiate the medical claims for a new device, based on the product’s nature and potential risk.

The data are then reviewed by experts within, and sometimes outside, the FDA.  The 510(k) process is an important tool for ensuring that devices entering the market do not raise new questions regarding safety or effectiveness”

In conclusion, the 510(k) submission process is a rigorous one that leads to clearance to market a device, but also requires adherence to strict manufacturing and quality controls.