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.

Federal Food, Drug, and Cosmetic Act (FD&C Act)

Federal law

Code of Federal Regulations Title 21 (21 CFR)

FDA regulations

Medical Device Databases

21 CFR Part 7 - Enforcement Policy

FDA regulation

21 CFR Electronic Records; Electronic Signatures

Final Guidance Document

21 CFR Part 801 Labeling

FDA regulation

21 CFR Part 803 Medical Device Reporting

FDA regulation

21 CFR Part 806 Medical Devices: Report of Corrections and Removals

FDA regulation

21 CFR Quality System Regulation

FDA regulation

21 CFR Unique Device Identification

FDA regulation

510(k) Premarket Notification Database

Medical Devices Database

Premarket Approval (PMA) Database

Medical Devices Database

Easy to Understand. Easy To Use.

Key Takeaways

  1. Determine if your product meets the definition of a medical device per Section 201(h) of the Food, Drug & Cosmetic Act.
  2. Determine if an appropriate product classification exists for your product
  3. Classify Your Device and Understand Applicable Regulatory Controls
  4. Select and Prepare the Correct Premarket Submission
  5. Send your Premarket Submission to the FDA and Interact with FDA Staff During Review
  6. 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

Democratizing MedTech Regulatory Knowledge

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