Practice Areas

Pathmaker FDA Law has over 30 years of experience in guiding medical device and pharmaceutical businesses in getting their products approved or cleared. We understand what regulatory bodies require and what path is right for you to get your drug or device to market. 

Medical Devices

510(k) Submissions

We’ll guide you through the process and help craft the 510(k) submission to ensure that it meets the substantial equivalence criteria and is approved on its first submission.

PMA Submissions

Our team will help you put together your pre-market approval to demonstrate that your device is safe and effective.

De Novo Submissions

We’ll help guide you through the process when this is the case to get your device to market.

MDD and MDR

We can help create your plan to gather clinical data to continue to market in Europe.

513(g)s

We will help craft your device description if you are not sure what category your device falls into.

International Medical Device Submissions

We can help you prepare your submission for an unknown or unfamiliar market.

Investigational Device Exemptions

We will help you through the approval process to get safety and effectiveness data. 

NIOSH N95 Applications

We will guide you through the confusing NIOSH N95 application.

Pharmaceuticals

New Drug Applications

We will assist you in crafting your application to demonstrate your new drugs safety and effectiveness.

Investigational New Drug Applications

We will help you prepare for meeting with FDA to obtain FDA feedback prior to submission.

Drug type A, B, and C Meetings

We can help you prepare what you will need to get your drug to market faster and approved by the FDA.

Other Services

Request for Designation

We will help you determine what regulatory pathway you will need to follow depending on if you are bring a devices, drug or both to market.

Pre-Submissions

We’ll help you prepare for meeting with FDA to obtain FDA feedback prior to submission.

Pre-Submission Meetings

The team at Pathmaker will go with you to meet FDA to obtain their feedback prior to a submission.

FDA Milestone Meetings

We will provide the information and strategy you need to prepare for a meeting with the FDA regarding your drug or device.

Registration and Listing

Pathmaker will guide you through the process of registering and listing the manufacturing facility for your product.

General Guidance

We’ll guide you through the process and help craft the 510(k) submission to ensure that it meets the substantial equivalence criteria and is approved on its first submission.

Clinical

We’re here to help you develop our clinical trials and evaluation plan.

Compliance

We’ll help you keep your products on the market so you can focus on what you do best.

Quality

Our team can help ensure your quality systems pass your next audit.