US Food and Drug Administration have published final guidance explaining when changes to registered devices warrant filing new 510(k) premarket notifications to the agency.
The draft guidance for covering changes to a registered device’s hardware and software that necessitates new 510(k) clearance was released in August 2016, following the release of the final guidance there are no major changes from the previous draft.
Changes that may require new 510(k) filings
- Any hardware change intended to improve a device’s safety or effectiveness requires a new 510(k) application.
- Changes to labelling; technology, engineering or performance; or materials may also require new premarket notification submissions.
For device software, FDA requires submission of new 510(k) applications in the following instances:
- Change introduces a new risk or modifies an existing risk that could potentially result in significant harm.
- Change causes the need for a new risk control measure or modification to a current control measure to address a potentially dangerous situation that could cause significant harm
- Change significantly affects clinical functionality or performance specifications directly tied to the device’s intended use
If you need support creating, submitting or keeping track of your 510(k)’s reach out to our experts or view a demonstration of our product please reach out to us on [email protected] or call the team on +44 1244 287 900.
Christian Hay, Senior Consultant Healthcare for GS1 Global Office has spoken out about revised IDMP standards.
Mr Hays explains:
IDMP standards are essential for the world’s increasingly integrated healthcare. They provide the precise architecture for the computerization of information on medicinal products all around the world. When regulators adopt IDMP, their capacity to interoperate with each other makes for safer patient care; this is, for example, a huge benefit for adverse-event reporting and for documenting medication in patient records.
The ISO IDMP working groups are currently collaborating on creating the implementation guides and will cover the following aspects:
- Medicinal product name
- Ingredient substances
- Pharmaceutical product (route of administration, strength)
- Marketing authorization
- Clinical particulars
The implementation of ISO IDMP will have a large impact on the industry and your company, Instem already supports XEVMPD through Samarind RMS and can support you as you transition into IDMP. To speak to one of our experts or view a demonstration of our product please reach out to us on [email protected] or call the team on +44 1244 287 900.
A major cooperation milestone has been reached between the European Commission & the US FDA.
November 2017 sees a mutual recognition agreement drafted, enabling the recognition of inspections of manufacturing sites for human medicines conducted in their respective territories. This cooperation will aim to improve the use of available resources to safeguard quality and safety of medicines.
The agreement enables both the EU authorities and the FDA to make better use of their inspection resources and focus on sites of higher risk where active pharmaceutical ingredients and medicines for the EU or US markets are manufactured.
European Medicines Agency
The FDA has released draft guidance for its new Breakthrough Medical Device Programme which will replace the current priority review programs including the Expedited Access Pathway (EAP) and the Priority Review Program.
Features included in the new guidance:
- Review of product which could lead to jumping the queue
- More interactive communications
- Post Market data collection in lieu of Pre Market data collection
- Ease sponsors’ clinical study design obligations
- Support from FDA review teams
- Expedited review of manufacturing sites
- Impacts 510(k), Premarket Approval (PMA), Investigational Device Exemption (IDE) and de novo applications.
For more information or a discussion with our experts on how this impacts your medical device products please reach out to Instem and the Samarind RMS team on [email protected] or call the team on +44 1244 287 900.
The Instem team are off once again and are attending this years CPhI. A great show and another opportunity for you to meet with us face to face!
Are you going to the show? Want to set up a meeting with our experts attending the show?
Contact us on [email protected] or call a member of the team on +44 (0) 1244 287 900 to secure your time slot.
Instem is proud to once again to sponsor the TOPRA awards for regulatory excellence! Our product Samarind RMS supports the award for Innovation and will be represented by our team and customers at this years awards dinner. This year’s venue will be in London at the historical Waldorf hotel!
We wish all nominees the best of luck and look forward to cheering you on in November.