Medical Devices & Combination Products

According to FDA, a medical device is "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is intended for the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease or other condition”.

In the U.S., as well as in other countries, medical devices must be either approved through a Premarket Approval (PMA) process or cleared via a 510(k) submission before they can be marketed. These products must not only demonstrate proof of safety and effectiveness but must also adhere to current Good Manufacturing Practice (cGMP) standards throughout their distribution and use by patients. 

Services offered by Prologos Law:

• FDA Administrative Proceedings

• Form 483, Warning Letters and Consent Decree

• IRB participation and auditing

• Action Indicated Notices

• US Customs Product Entry

• Product Exports

• Type A, B, C Meetings

• CRO / CMO Agreements

• Clinical Trial Agreements

• Informed Consents and Case Reports Forms

• Clinical Operations Support for Site Initiation and Enrollment

• Good Laboratory Practices (GLPs)

• Good Clinical Practices (GCPs)

• Current Good Manufacturing Practices (cGMPs)

• Regulatory Strategy (IDE, 510k, DeNovo, QSubs, PMA)

• Humanitarian Device Exemption (HDE)

• Unique Device Identification (UDI and GUDID) 

• IRB participation and auditing

• Training

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