Jan 2, 2011

510(k) Approval Timeline Part 2

My original 510(k) approval timeline is my post popular post ever!  I didn't even follow up with my latest project information.  We extended the disposable product line and it was 30 day FDA review, no questions asked / response required, approval in April to May 2010.  We justified not doing sterilization, biocompatibilty, shelf life, and packaging.  All in all it was about as good as it can get time wise.  Timeline went something like this:

  • August to December 2009: Concept and prototype to design
  • Jan to March 2010: Product build and verification / validation testing
  • April to May 2010: 510(k) Approval
Our validation was an animal study using a physician, who filled out a questionnaire like one to ten, how much is this better than the predicate device after he or she used it, oh boy did I learn something there, I'll go over that some other time.

Now we just have to sell them...

1 comment:

Anonymous said...

Lo and behold…..challenges and changes galore for the medical device industry at global and some key local levels (the need for glocal “Current” Good Regulatory Practice to successfully “dance” in tune with the regulators cannot but be overemphasized):
• US-FDA’s Innovation Initiative and CDRH’s assurance of the safety and effectiveness of medical technologies
• GHTF disbanding & regrouping with regulators only (without industry participation – while the Asian Harmonization Working Party (AHWP) web site is sponsored by industry stalwarts)
• Recast “legal framework” initiative of (possible repeal) Directives 90/385/EEC, 93/42/EEC & 98/79/EC by Q1 2012 – led by Health and Consumer Protection Directorate General of the European Commission (DG-SANCO) [while the industry is yet to catch up with the last technical revisions per Directive 2007/47/EC]
• Health Canada’s Summary Technical Documentation (STED) implementation effective July 2011 for non-in vitro diagnostic Class III and IV Premarket Medical Device Licence Applications
• Status of ASEAN Medical Device Directive (AMDD) given the glaring lack of information from ASEAN Consultative Committee on Standards and Quality (ACCSQ) Medical Device Product Working Group (MDPWG).

………………………………..Amarjit S. Jowandha