Ultimate Guide For FDA Medical Device Approval Process

If you are medical device manufacturer and looking for FDA for your device then read our complete article to know about FDA, FDA approval process, the time required for FDA approval.

In the United States, all activity related to the medical device is control by the U.S. Food and Drug Administration (FDA) under the Medical Device Regulation Act of 1976 follow to the Federal Food, Drug and Cosmetics Act of 1938.

FDA medical device classification:

Medical Device classified into three classes basically as per FDA. Class I devices is self-enrolled but most of the Class II devices need FDA 510(k) submission and for Class III required Pre-Market (PMA) submission.

Class I: Low Risk (Example: Hospital Beds And Tongue Depressors)

Class II: Medium-Risk (Example: Blood Pressure cuffs, Absorbable suture)

Class III: High-Risk (Example: Coronary Stent, Implantable pacemaker) FDA medical device approval process:Step-by-step FDA medical device approval process is as follows: Step 1:Classified your device as per FDA medical device classification. Also, check the three letter Product Code and seven digit Regulation Number related with the predicate devices you recognize.

Step 2:Beside Part 820, most Class I medical devices required to agree with QSR (GMP). Execute QMS (Quality Management System) for Class II and Class III. Creative Class II, and all Class III, devices will likely require clinical investigations. Get "Pre-Submission (Pre-Sub)" contribution from the FDA.

Step 3:In the event that the clinical examination will be required, they ought to apply for an Investigational Device Exemption (IDE). Develop clinical trial agreement and conduct studies.

Step 4:For Class II medical devices, plan and submit 510(k) Premarket Notification application and pay the related charge. For Class III devices, prepare and submit Premarket Approval (PMA) application. Pay PMA accommodation cost.

Step 5:For Class III medical devices, FDA conducts office examinations of each real provider related to the plan and creation of your gadget. All gatherings must be reliable with FDA QSR.

Step 6:For the Class II medical devices, the FDA issues 510(k) freedom letter and posts it on the web. Also, for Class III medical devices, the FDA issues approval of PMA letter and posts it on the web.

Step 7:Starting at now, you ought to be in full consistency with QSRs. The FDA won't look at Class I or II medical device producers for consistence preceding devices registration but does conduct unplanned inspections and can issue a Form 483 for non-compliance.

Step 8:If you have no nearby nearness in the US, name the FDA US Agent delegate as a neighbourhood purpose of contact with the FDA.

Step 9:Rundown your gadget and enlist your organization using FURLS system on the FDA site according to 21 CFR Part 807. Pay charges for Establishment Registration and Listing which must be renewed each year.

Step 10:You are right now prepared to move your devices in the US. Your association and device registration status will be recorded on the FDA site.

Operon Strategist provide guidance to manufacturers for FDA medical device approval process.

Medical devices consultant