Rachel Beavins Tracy, EtQ
This year is proving to have some big changes in store for life sciences companies. The new Trump administration brings changes in key areas such as the Affordable Care Act and Medical Device User Fee Agreements (MDUFA). So, which regulatory issues should life sciences companies watch for this year? We’ve put together a shortlist of key regulatory issues in 2017.
1. FDA Finalizes Premarket Submission Guidelines for Medical Device Cybersecurity Management
Medical device cybersecurity has been getting a lot of attention lately, with the federal government investigating dozens of medical devices last year over suspected vulnerabilities.
To help manufacturers combat this growing risk, the Food and Drug Administration released new guidance for premarket submissions on medical devices. Highlights include recommendations to:
- Use the 2014 NIST voluntary Framework for Improving Critical Infrastructure Cybersecurity.
- Develop cybersecurity Risk Management programs to better identify and fix device vulnerabilities.
- Create disclosure plans for when manufacturers discover vulnerabilities. Manufacturers can still provide consumer alerts and patches without notifying the FDA, unless it’s a problem that would impact device function or result in serious health impacts.
This guidance is consistent with federal requirements that medical device manufacturers implement Quality Management Systems that ensure compliance with Current Good Manufacturing Practices (cGMP).
2. 21st Century Cures Act
After previously stalling over disagreements on how to pay for it, the Senate overwhelmingly passed this act and it was signed into law in December 2016.
The 21st Century Cures Act is set to:
- Ensure the expansion of medical research
- Accelerate new drug and medical device approval
- Provide $1 billion in grants for drug abuse and prevention programs over the next 2 years
- Strengthen mental health parity regulation
It’s clear that the new legislation favors medical device manufacturers who have established processes for Risk Management.
3. Europe Adopts New Medical Device Regulations
In March, European Union (EU) regulators enacted sweeping changes to medical device regulations, which promote product consistency while better protecting patient safety.
The new laws tighten requirements in multiple areas of medical device manufacturing, including:
- Extending compliance requirements throughout the supply chain.
- Enhanced packaging and recordkeeping requirements.
- Improved traceability and post-market surveillance.
For those companies doing business in the EU, the new requirements involve taking steps around supply chain contracts, as well as updating internal procedures around regulatory compliance and Employee Training.
4. New Guidance around the Drug Supply Chain Security Act
The implementation of the Drug Supply Chain Security Act (DSCSA) is well underway. The law’s enactment will take place in multiple stages over the coming decade, with the government aiming to create an interoperable electronic system to:
- Verify drug legitimacy at the package level.
- Improve detection of illegitimate drugs in the supply chain.
- Improve the efficiency of drug recalls.
Of course, if you’re among the growing list of manufacturers using FDA Compliance Software, you’re already ahead of the game. By integrating your data across the production process, including tracking suppliers, you can provide a more secure, traceable product that extends safety into the supply chain.