Navigating Medical Device Design Control & Risk Management
Helping you navigate integrated design control and risk management, while providing complete visibility into the entire development process for your medical device.
Verification and Validation (V&V) is a necessary step in every type of product development. Verification is a process of evaluating the development lifecycle to check if a team is on the right track of creating the final product. Validation is the process of evaluating the final product to check whether the software meets the business needs. Are we making the right product and did we make the right product = V&V
Pulse Check: New Revision for ISO 62366-1 Application of Usability Engineering to Medical Devices Michelle's Moment: Last month, I had attended a "Meet the Experts" event sponsored by UL. The day was very informative with presentations by their experts on human factors engineering (HFE), 60601-amendment update, risk management, and material characterization. One topic of particular interest covered the recent changes to ISO 62366-1 Application of Usability Engineering to Medical Devices which was updated in March. Somehow amid the myriad of other regulatory changes this year, this one managed to slip by me! For others who may have missed the revision, here are some highlights:
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Pulse Check: New FDA Draft Guidance: Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices Michelle's Moment: The recent guidance Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices proposes a method for companies to use relevant scientific data for adult clinical trials and appropriate statistical tools to facilitate the application or different data sets.
Pulse Check: FDA Provides Clarification on the "Add-to-File" Process Michelle's Moment: For those of you who follow my newsletters, blogs, and webinars, you will be familiar with my commentary on FDA's recent final guidance Safety Considerations to Mitigate the Risk of Misconnection with Small-bore Connectors Intended for Enteral Applications. This guidance recommended industry use an "add-to-file" pathway to submit design changes needed to comply with the new connector standards. I don't know about you, but this was the first I had heard of an "add-to-file". I went on a mission to find out more about what the FDA expects this process to look like.
Pulse Check: New FDA Draft Guidance: Patient Preference Information - Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device Labeling Michelle's Moment: FDA is listening to patients, are you? Recently the FDA reiterated in a blog post the profound impact that patient advocate groups have in influencing public policy and FDA perspective: "What we learn through these conversations informs our work. It becomes part and parcel of the regulations we put into place to promote and protect the public health."
Pulse Check: Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions Michelle's Moment: FDA has released a number of related guidance documents that are all reinforcing the same theme: Expedited Access for Premarket Approval and De Novo Medical Device Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approvals and De Novo Classifications
Pulse Check: FDA Draft Guidance on the Acceptance of Medical Device Clinical Data from Studies Conducted Outside the U.S. Michelle's Moment: The FDA released a new guidance on the Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States (OUS). This guidance focuses on considerations sponsors should take into account when initiating, or relying on previously collected data from, an OUS clinical study to support product submissions.
Pulse Check: CDRH Seeks Participants for the Electronic Submission for Home Use Device Labeling Pilot Program Michelle's Moment: With the announcement launching FDA’s Medical Device Home Use Initiative (MDHUI) in 2010, FDA committed to several actions to support the safety and safe use of medical devices in the home. The commitments included to: Establish guidelines for manufacturers of home use devices; Develop a home use device labeling repository; Increase public awareness and education.
Pulse Check: New FDA Regulatory Guidance Document: Safety Considerations to Mitigate the Risks of Misconnection with Small-bore Connectors Intended for Enteral Applications Michelle's Moment: The FDA's new guidance document Safety Considerations to Mitigate the Risks of Misconnection with Small-bore Connectors Intended for Enteral Applications introduced a concept I was previously unfamiliar with - "Add-to-File". The guidance introduced it casually as if it was a common pathway industry was familiar with and used often "If such devices with an existing 510(k) clearance have been modified... FDA does not intend to object if firms submit a declaration of conformity... in an 'add-to-file' to their existing 510(k) rather than submitting a new 510(k)". That's it. That's the extent of explanation and instruction on add-to-file.