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.
Contact us to guide your business to “yes”.
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
No predicate device? We’ll help guide you through the process when this is the case to get your device to market.
MDD and MDR
Need help making your device MDR compliant? We can help create your plan to gather clinical data to continue to market in Europe.
513(g)s
Not sure what class your device falls into? Pathmaker will help craft your device description.
International Medical Device Submissions
Investigational Device Exemptions
NIOSH N95 Applications
Confused by NIOSH’s rigorous N95 application requirements? We have assisted multiple clients in attaining NIOSH approval.
Pharmaceuticals
New Drug Applications
Submitting a New Drug Application? Pathmaker will assist you in crafting your application to demonstrate its 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
Need help preparing for a meeting with FDA? Let us help you prepare what you will need to get your drug to market faster.
505(b)(2) Pathway
Orphan Drugs
Other Services
Request for Designation
Is your product a device or a drug or both? We will help you determine what regulatory pathway you will need to follow.
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
Preparing for meeting with FDA for your drug or device? We will provide the information and strategy you need to prepare.
Registration and Listing
Need to register a manufacturing facility with FDA? Pathmaker will guide you through the process of registering and listing where your product is made.
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
Need help developing your clinical trials and evaluation plan? We’re here to help.
Compliance
We’ll help you keep your products on the market so you can focus on what you do best.
Quality
Need help setting up quality systems? Our team can help ensure you pass your next audit.
Get in touch by filling out this quick form
