Regulatory Knowledge At A Glance
Regulatory Landscape
Resource Center
united States of America
Key laws, acts, regulations, directives, guidelines, guidance documents, standards and other relevant resources for business development and regulatory professionals in the medical industry.
Easy to Understand. Easy To Use.
Key Takeaways
- Determine if your product meets the definition of a medical device per Section 201(h) of the Food, Drug & Cosmetic Act.
- Determine if an appropriate product classification exists for your product
- Classify Your Device and Understand Applicable Regulatory Controls
- Select and Prepare the Correct Premarket Submission
- Send your Premarket Submission to the FDA and Interact with FDA Staff During Review
- Comply with Applicable Regulatory Controls Including the Establishment Registration and Device Listing
Step 1
Strategy
Develop a strong and agile regulatory strategy with a long-term view.
Step 2
Compliance
Ensure compliance with pre-market and post-market requirements.
Step 3
Communication
Interact and negotiate with regulatory authorities as much as necessary .
A point in history
The Food, Drug and Cosmetic Laws
1906 | Pure Food and Drug Act |
1912 | Sherley Amendment |
1938 | FD&C Act (elixir sulfanilamide) |
1944 | Public Health Service (PHS) Act |
1951 | Durham-Humphrey Amendment |
1958 | Food Additives Amendment |
1962 | Kefauver-Harris Amendment (thalidomide) |
1976 | Medical Device Amendments (faulty medical devices had caused 10,000 injuries) |
1983 | Orphan Drug Act |
1984 | Drug Price Competition and Patent Term Restoration Act |
1990 | Safe Medical Devices Act (SMDA) |
1992 | Medical Device Amendments |
1992 | Prescription Drug User Fee Act (PDUFA I) |
1997 | FDA Modernization Act (FDAMA) |
2011 | Food Safety Modernization Act (FSMA) |
2012 | Food and Drug Administration Safety and Innovation Act |
2013 | Drug Quality and Security Act |
2015 | Improving Regulatory Transparency for New Medical Therapies Act |
2016 | 21st Century Act (CCA) |
2018 | Right to Try Act |
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